ART-PLAN
TheraPanaceaART-Plan is an advanced software tool designed to assist medical professionals in cancer radiotherapy planning. It supports visualization and manipulation of 3D multi-modal medical images (CT, MR, PET-CT, CBCT, 4D-CT) and includes AI-driven automatic and semi-automatic segmentation of organs at risk and lymph nodes. It also allows image registration and generation of synthetic CT images from MRI, facilitating precise and efficient radiation treatment planning.
Intended Use
Software for multi-modal visualization, contouring and processing of 3D images of cancer patients for whom radiotherapy treatment is prescribed, supporting AI-based contouring and multi-modal image registration.
Technology
Web-based software platform that supports display, processing, registration (rigid and deformable), and AI-based segmentation of multi-modal DICOM-compliant images including CT, MR, PET-CT, CBCT, and 4D-CT. Offers automatic delineation of organs at risk and lymph nodes using deep learning, and synthetic CT generation from MR images. Supports cloud or server deployment.
Performance
Performance testing included extensive quantitative and qualitative validation of auto-segmentation and image registration modules against acceptance criteria derived from literature and clinical expert standards, with Dice Similarity Coefficients above thresholds and clinician qualitative evaluations indicating clinical acceptability. Additional testing showed equivalence with predicate devices and performance on pediatric and US populations. Software verification and validation followed FDA guidance for major software risk level.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/21/2022
2 months - 2
FDA Approval
6/17/2022
Other devices from TheraPanacea
- ART-Plan (v.2.2.0)2024 • 510K
- ART-Plan2023 • 510K
- ART-Plan2023 • 510K
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