ART-Plan
Therapanacea SASART-Plan is a medical imaging software that helps clinicians visualize, contour, and process 3D multi-modal images like CT, MR, and PET-CT for cancer patients undergoing radiotherapy. The software uses AI to automatically delineate organs at risk and lymph nodes to assist in treatment planning, saving time and improving precision. It also supports image registration and generation of synthetic CT images from MRI.
Intended Use
ART-Plan is a software application intended to display, visualize, contour (including AI-based contouring), register, and manipulate 3D multi-modal medical images for cancer patients undergoing radiotherapy treatment.
Technology
ART-Plan combines two key modules: SmartFuse for image fusion and Annotate for automatic, semi-automatic, and manual contouring. It supports DICOM 3.0 data across multiple modalities (CT, PET, MR) and includes AI deep learning-based segmentation models for various anatomical regions. The system also allows generation of synthetic CT images from MR data and incorporates rigid and deformable image registration.
Performance
ART-Plan v1.10.1 was tested extensively for performance, showing equivalence to the predicate device. Performance evaluations included quantitative tests using Dice Similarity Coefficient to compare AI contours with expert annotations, qualitative expert reviews, and robustness checks to ensure no overfitting. Tests covered multiple anatomical structures across CT and MR images, with acceptance criteria meeting or exceeding AAPM standards. Bug fixes were verified with the same criteria. Clinical and animal studies were not conducted for this submission.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/4/2023
3 months - 2
FDA Approval
4/19/2023
Other devices from Therapanacea SAS
- ART-Plan (v.2.2.0)2024 • 510K
- ART-Plan2023 • 510K
- ART-PLAN2022 • 510K
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