ART-Plan
TheraPanaceaART-Plan is a radiotherapy treatment planning software that assists clinicians by visualizing and fusing multimodal medical images, automatically segmenting organs and lymph nodes using AI, generating synthetic CT images from MR and CBCT scans, computing dose distributions for radiation therapy, and aiding in treatment adaptation decisions. It enhances workflow efficiency and accuracy for trained professionals managing radiotherapy for cancer patients.
Intended Use
ART-Plan is a software intended to be used by trained clinicians familiar with radiation therapy to aid radiotherapy treatment planning involving visualization, registration, segmentation, synthetic CT generation, dose computation, and adaptation decision-making.
Technology
ART-Plan integrates AI-driven automatic delineation (deep learning-based segmentation), multimodal rigid and deformable image registration, synthetic CT generation from MR and CBCT, and dose computation within a software platform accessible via standard web browsers. The software supports manual and semi-automatic contouring, visualization and evaluation of fused images, and assists in offline adaptation decision-making for radiotherapy.
Performance
ART-Plan's modules have been validated through extensive clinical and bench testing including qualitative and quantitative evaluation of automatic segmentation, image registration, synthetic CT generation, and dose calculation using metrics like Dice Similarity Coefficient (DSC), gamma passing rates, and clinical expert assessments. Testing demonstrated safety, effectiveness, non-inferiority to predicate devices, and no significant bias across demographic subgroups.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/16/2023
4 months - 2
FDA Approval
12/22/2023
Other devices from TheraPanacea
- ART-Plan (v.2.2.0)2024 • 510K
- ART-Plan2023 • 510K
- ART-PLAN2022 • 510K
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