Name and address of the manufacturer:

TheraPanacea

7 bis boulevard Bourdon
75004 Paris
France

Product name:

ART-Plan™ is a medical device.

UDI: (01)03770019940006(10)1.10.1(11)220511

The version of the software is 1.10.1 mentioned on its “About” module of the software.

Intended use:

 ART-Plan is a software designed to assist the contouring process of the target anatomical regions on 3D-images of cancer patients for whom radiotherapy treatment has been planned.

The SmartFuse module allows the user to register 3D-images and display them to facilitate the comparison and delineation of image data by the user.

With the Annotate module, users can create and edit the contours for the regions of interest on 3D-images.

The images and contours created require verifications, potential modifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy.

The device is intended to be used in a clinical setting, by trained professionals only.

 

Performance:

 Quality:

The quality of the contours may depend on the skills of the user and the quality of the imagery.

Processing time:

Under optimal conditions, the contouring of an anatomy with the automatic contouring tool can take between 2 and 3 minutes, depending on the number of structures detected.

If several actions are carried out simultaneously in ART-Plan, the processing time may increase.

   A user manual is provided with the device.

   Precautions for use and contraindications:

The software is contraindicated outside the context of radiotherapy. Only patients undergoing radiotherapy treatment may use the software.

  Warnings:

 

  • The user must take note of all the recommendations mentioned in this manual. TheraPanacea cannot be held responsible for any consequences of not following these recommendations.

 

  • ART-Plan is developed as a tool to assist in the preparation and follow-up of radiotherapy treatment and should not be used as a basis for diagnosis. Do not use ART-Plan outside the scope defined above.

 

  • Do not create a user account for a person who is not trained in the use of the software and/or does not have the necessary skills to use a software manipulated in the preparation of a radiotherapy treatment.

 

  • To prevent musculoskeletal and eye problems, the user should take regular breaks to limit the fatigue leading to the above-mentioned problems.

 

  • When connecting to the platform with a phone or tablet screen, the user should select the “Computer version” option of their communication device. The platform is optimally used for a screen size of 17 inches and more. It is not recommended to use the ART-Plan platform on a smaller device as it could lead to errors due to poor visualization or understanding of the interface.

 

  • The server must be installed in a room with air conditioning and a high-voltage outlet.

 

  • Do not install ART-Plan on your own initiative, without going through TheraPanacea. The configuration and use of ART-Plan in a non-contractual context could lead to data loss and disturbances on the equipment and the clinical treatment.

 

  • The server installation environment must be specified to TheraPanacea before the installation date. Non-compliant environment specifications could cause damages to the server.

 

  • Do not use the software after the period covered by the contract. Therapanacea will not be able to ensure the maintenance of the installed version beyond the period defined in the contract.

 

  • ART-Plan is a Web solution. It may be necessary to refresh the page (F5 or Refresh button of the browser) in order to visualize the result of some tasks.

 

  • If a corrupted volume is imported into ART-Plan, its visualization and use can lead to a malfunction of the software or a misuse by the user.

 

  • If one or more slices between the second and penultimate slice of a DICOM volume are missing, the volume cannot be loaded in the Annotate module. The user must verify that the total number of slices of the imported volume in ART-Plan is the same as the total number of slices of the volume indicated in the hosting from which the DICOM was imported.

 

  • Caution: do not import corrupted DICOM or DICOM containing erroneous data. It could lead to errors or malfunctions.

 

  • A data format other than the one specified in this chapter will not be taken into account by the platform. To load DICOM files into ART-Plan from a local storage medium, the user must first compress them into a .zip file.

 

  • Import of data into ART-Plan will not work if required DICOM tags are not filled out and/or non supported information are indicated. Please refer to ART-Plan’s DICOM Conformance document to know required and supported DICOM tags by the solution.

 

  • A user account must be opened to users who have been trained by the manufacturer or by an ART-Plan administrator in the user structure of the software. Do not create a user account for a person who is not trained in the use of the software and/or does not have the necessary skills to use a software manipulated in the preparation of a radiotherapy treatment.

 

  • The contours made in ART-Plan must be checked and validated by one or more authorized person(s).

 

  • The user must circumvent on quality imagery. Lower quality volumes or volumes with artifacts (e.g., an implant) may result in misinterpretation of the patient’s anatomy by the software and thus produce low quality contours. Please check the quality of the images before loading them into the ART-Plan solution.

 

  • The processing time depends on the anatomy, the equipment used by the health care institution, the number of users connected and the type of actions already underway. Additional time must be taken by the user to check and possibly modify the automatically generated contours.

Please note that there might be variations in the processing time of ART-Plan’s functions.

 

  • Some firewalls, if active, may block access to ART-PLAN.

 

  • Editing a category instantly changes the rights and access of all users in the category. The user modifying the category must verify that all impacted users have the rights and the appropriate access to their responsibilities, skills and experience.

 

  • Deleting a category results in the modification of each user account belonging to that category. They will be assigned the default category “User”. The user deleting a category must ensure that impacted users recover the rights and access that correspond to their responsibilities, skills and experience.

 

  • The user creating or modifying a user account must verify that the rights and access authorized by the assigned category match the skills and experience of that user.

 

  • Changing the category of a user account changes its rights and access. The user modifying the account must verify that the impacted user has the skills, responsibilities and experience required to belong to the selected category.

 

  • If the category of an account has been changed since deactivation, the user’s rights and access will also be changed. The user reactivating the account must verify that the new rights and accesses of the category assigned to the impacted user still correspond to his skills and experience. If this is not the case, he must assign a new category.

 

  • In order not to delay the work of users, users with the appropriate rights should regularly export and then delete patients to free up storage space.

 

  • These actions are irreversible. We advise you to export the data to an external storage space before deleting it.

 

  • Before deleting DICOMs from ART-Plan platform, the user must ensure that the patient’s DICOMs are stored on another medium.

 

  • If a deactivation request has been made by TheraPanacea, it is imperative that the clinical practice facility deactivate the ART-Plan solution.

 

  • If the deactivation of the solution is decided by the clinical practice facility, TheraPanacea cannot be held responsible for the deactivation of the solution and the consequences of the impossibility to use the solution.

 

  • Do not reactivate the solution until TheraPanacea has informed that the adverse event has been resolved.

 

  • The administrator must be fully aware of the consequences related to the management of the platform and the opening and definition of user accounts.

 

  • The quality and reliability of the above information depends on the imported data. Please verify data before importing them into ART-Plan.
  • Verify the total number of slices of imported volumes.

 

  • Caution: If there is an error in the Frame Of Reference DICOM tag, the imaging exams may be grouped incorrectly. In case of inconsistency, please refer to the attributes of the DICOM file.

 

  • In case of re-import of a corrupted DICOM, the DICOM present in ART-Plan and re-imported will be replaced. The structures created and contoured in Annotate on the re-imported DICOM are not retained.

 

  • Please verify that the type of import selected suits your needs.

 

  • The detection of similarities depends on the information contained in the DICOM tags.

 

  • When the user chooses to group data with different identifying information in one and the same patient, the identifying information is not changed in the DICOM files. As a result, the exported data will return to its original identifiers.

 

  • The user must verify that the value of the Patient’s Sex Attribute tag of the primary image used is filled to propose the appropriate structures.

 

  • A message informs the user of the identity of the person originally on the project. If the user validates the handover, the user initially on the project is informed of the identity of the person who took the handover. The actions performed by the initial user are automatically saved before being redirected to the home page.

 

  • Before deleting DICOMs from ART-Plan platform, the user must ensure that the patient’s DICOMs and/or projects from the ART-Plan platform are stored on another medium.

 

  • The user must verify the identity of the patient and the name of the project before performing any action on the project.

 

  • The time it takes to load a project can affect the quality of the images viewed. The user must wait a few seconds before editing the project for optimal handling and visibility.

 

  • The primary image is used for patient positioning throughout the radiotherapy sessions. Contours and treatment planning are done on the primary image. When creating a project, please verify that the primary image corresponds to the positioning image.

 

  • Only the following images can be used as primary image when creating a project:
    • CT image whose patient position is indicated as HFS, HFDL, HFDR, HFP, FFS, FFDL, FFDR or FFP in the Patient position tag (0018, 5100).
    • MR image An axial MRI whose value contained in the tag Image Patient Orientation (0020,0037) is (1,0,0).

 

  • Image quality is variable. The user must ensure the good quality of the primary image before starting the contouring step.

 

  • The choice of an appropriate primary image is the responsibility and appreciation of the user.

 

  • The choice of an appropriate secondary image is the responsibility and appreciation of the user.

 

  • The user must check that the structures added with the “Structure list” function have not already been created by:

–        The “New Structure” function.

–        The launch of an automatic contouring.

–        Adding another list of structures.

  • If the structure added with the “Structure list” function has already been created, it will have the same name but contain an incremental number.

 

  • The quality of the simple brush depends on the tracing performed by the user.

 

  • The quality of the agile brush depends on the tracing done by the user and also on the quality of the image.

 

  • The quality of the single polygon depends on the plotting done by the user.

 

  • The quality of the agile polygon depends on the plotting done by the user and also on the quality of the image.

 

  • The quality of the interpolation depends on the plot made by the user and also on the quality of the image. Interpolated contours must be checked by the user.

 

  • The automatic segmentation function makes a proposal to the user. This proposal must be checked and validated by one or more users with the appropriate skills.

 

  • The (0010,0040) Patient’s Sex Attribute tag is taken into account for the autoseg:

– if the tag is “F” or “M”, the sex specific organs (prostate, breast, etc.) are coutoured according to the tag

– if the tag is empty or “O”:

– if batch : no contour is delineated except external contour

– if auto segmentation on Annotate : only common contours to the 2 sexes are delineated

  • The Truefisp pelvis model, when using a Linac MRI, and the model pelvis T2 are not adapted to the female anatomy.
  • The automatic contouring (including external contour) function may generate inappropriate contours in the following cases:
    • When the volume used as the primary image is an image taken of a child
    • When the patient has a particular anatomy. This assessment is the responsibility of the user.
    • When the primary CT volume is that of a patient not positioned on his back at the time of acquisition.
    • If the value entered in the Patient Position tag (0018, 5100) is incorrect.
    • When the value entered in the Patient’s Sex Attribute tag (0010,0040) is empty or incorrect.
    • When the DICOM-CT contains an unusually high number of slices.
    • When the quality of the images used as input is not satisfying enough. Therefore, the contours produced in a CBCT might have a low resolution.
    • When the primary volume is an MRI whose acquisition sequence is not compatible with the selected auto-contouring model.
    • When the patient is unusually positioned on the image (image not centered on the patient, head rotated on the side…)

 

  • When the user creates a structure, a standardized name is proposed. However, the user can modify this proposal to give the structure a name of his or her choice. In this situation, when the automatic contouring function is launched, the interface cannot inform the user of the presence of a duplicate between the automatically contoured structures and those already present in the regions of interest area. The user must check that there are no duplicate structures between those he or she has created and those generated by the automatic contouring function.

 

  • In order to suggest the most relevant structures to the user, a CT that does not include a chiasma but does include a liver, is not considered as Head and Neck case. In that case, no Head and Neck structures will be automatically segmented.
  • External contour generation may not have satisfactory results when performed on anatomies not covered by automatic contouring:

–  Automatic contouring on CT images covers all anatomies.

–  Automatic contouring on MR images covers sequences and anatomies: Brain T1, Abdo TF, Pelvis T2, Pelvis TF.

  • Caution: it is not recommended to use low-resolution input images such as CBCT for autosegmentation, as it could lead to low quality contours.

 

  • In order to suggest the most relevant structures to the user, a CT that does not include a chiasma but does include a liver, is not considered as Head and Neck case. In that case, no Head and Neck structures will be automatically segmented.

 

  • The automatic contouring (including external contour) function on secondary image may generate inappropriate contours in the following cases:
    • When the volume used as a secondary image is an image of a child
    • When the patient has a particular anatomy. The evaluation is the responsibility of the user.
    • When the secondary volume is the CT of a patient not positioned on the back at the time of acquisition.
    • When the value entered in the Patient Position tag (0018, 5100) is erroneous.
    • When the value entered in the Patient’s Sex Attribute tag (0010,0040) is empty or erroneous.
    • When the DICOM-CT contains an unusually high number of slices.
    • When the quality of the input images is not satisfactory enough. For example, contours produced from a CBCT may have a low resolution.
    • When the secondary volume is an MRI whose acquisition sequence or orientation is not compatible with the selected contouring model.
    • When the secondary volume and the primary volume have significantly different cut thicknesses
    • When the patient is unusually positioned on the image (image not centered on the patient, head rotated on the side…)

 

  • The structure name and colour settings defined for automatic contouring also apply in the case of automatic contouring of a secondary image.

 

  • Please note that there might be variations in the quality of contour transfers in the case of rigid fusion for CT-CT replanning. If you are not satisfied with the result, Therapanacea advises to perform a deformable fusion or to use the manual tools available to improve the quality of the contours.

 

  • Contours must be reviewed and validated by users with the appropriate expertise and skills.

 

  • Non validated contours can be exported from ART-Plan and downloaded into another software. In that case, make sure to validate those contours before using them for treatment planning.

 

  • We hardly recommend not to export non-validated contours.

 

  • Depending on the type of MR-RT, the results may differ.

 

  • Bad image quality (artefacts, motion, uncommon high slice thickness, etc.) can lead to incorrect Pseudo-CT.

 

  • Please be careful to choose the correct pseudo-CT model associated with the primary MR image.

 

  • Although ART-Plan does not offer dose calculation tools, manual customization of HU values may affect future dose calculations computed on other devices based on modified CT. Please review every HU modification before exporting the CT.

 

  • Please check the quality of the pseudo-CT before validating it.

 

  • Please check the quality of contours from the automatic delineation, before using it to validate the pseudo-CT.

 

  • Particular attention is required when entering data in the tables “HU reference values” and “calibration curve”. Indeed, these values have an influence on the generation and evaluation of the Pseudo-CT.

 

  • Non validated contours can be exported from ART-Plan and downloaded into another software. In that case, make sure to validate those contours before using them for treatment planning.

 

  • Warped images (generated from a validated fusion) and other generated images in ART-Plan (projections, Pseudo-CT) can be exported from ART-Plan and downloaded into another software. In that case, please make sure to not confuse these images with original images. For this purpose, you can use the following DICOM tags:
    • Series Description (0008,103e): contains  “fusion” or the name of a projection or “Pseudo-CT”,
    • Image type (0008,0008) : “Derived”,
  • The automatic batch contouring functions(including external contour) can generate inappropriate contours in the following cases:
  • When the image used as the primary image is an image taken of a child.
  • When the patient has a particular anatomy. This assessment is the responsibility of the user.
  • When the primary image is that of a patient not positioned on his back during acquisition.
  • When the value entered in the Patient position tag (0018, 5100) is wrong.
  • The automatic contouring function to be applied depends on the user’s selection.

If the value entered in the Patient’s Sex Attribute tag (0010,0040) of the CT is empty or incorrect, automatic contouring is not launch as part of batch. The CT will be redirected to the destination application to facilitate the workflow but only the external contour will have been generated in ART-Plan.

 

  • Please check Patient’s Sex Attribute tag (001,0040) before sending an image to batch to verify that it is not empty and correct.

 

  • The automatic contouring function makes a proposal to the user. This proposal must be checked and validated by one or more users with the appropriate skills.

 

  • DICOM Series description tag must be checked before sending an image to batch. Installation centers using this configuration must inform users of the processes to be implemented according to their protocol.

 

  • In order to suggest the most relevant structures to the user, a CT that does not include a chiasma but does include a liver, is not considered as Head and Neck case. In that case, no Head and Neck structures would be automatically segmented.

 

  • Fusions must be verified before they are used in patients’ treatments.

 

  • All fusions initiated through manual or automatic methods may be modified and must be verified and approved by the users before use in a clinical context.

 

  • Caution: the maximum of the deformation scale of the deformation grid tool is 2 cm. All deformation values greater than 2 cm will be displayed with the same color (red) on the screen. For the exact deformation value, please refer to the information in yellow in the lower left corner of the screen.

 

  • Caution: this modification option causes the previously established fusion to be deleted.

 

  • Warning: In the case of a group of secondary images, validating a fusion will validate each warped image in the group. Please verify each warped image before validating the fusion.

 

  • Warning: In the case of a group of linked sources, deleting a fusion will delete each warped image in the group. Please make sure that no warped images are used.