ART-Plan (v.2.2.0)
Therapanacea SASART-Plan (v.2.2.0) is a medical software platform designed to help clinicians involved in radiotherapy for cancer patients. It allows users to contour regions of interest on 3D images, perform image registration and fusion from multiple imaging modalities (CT, MRI, CBCT), generate synthetic CT images using deep learning, and support decision-making for treatment replanning. This assists medical professionals in precisely targeting radiation therapy and adapting treatment based on daily patient imaging data, improving safety and treatment efficacy for cancer patients aged 18 and above.
Intended Use
ART-Plan's indicated target population is cancer patients for whom radiotherapy treatment has been prescribed, for whom relevant imaging data is available. It is not intended for patients under 18 years. Indicated users are trained medical professionals involved in radiation therapy. Use environments include hospitals and clinics.
Technology
ART-Plan is a software platform enabling 3D image contouring, multi-modal image registration (CT, MR, CBCT), AI-based auto-segmentation, and synthetic CT generation from MR and CBCT using deep learning. It supports dose computation on CT and synthetic CT for external beam photon irradiation and assists in replanning decisions by comparing dose and volume metrics across images.
Performance
Performance validation involved quantitative and qualitative evaluation of auto-segmentation (using metrics like Dice Similarity Coefficient and Hausdorff distance), propagation of contours, and dosimetric validation of synthetic CT and dose computation. Tests showed clinical acceptability with high agreement to expert manual contours and dose equivalence to conventional CT, confirming safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/22/2023
4 months - 2
FDA Approval
4/22/2024
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