ART-Plan+ (v3.1.0)

ART-Plan+ (v3.1.0) is a software platform for radiotherapy treatment planning used by cancer patients undergoing radiation therapy. It includes three modules: Annotate (automatic contouring of organs and tumors on CT/MR images), SmartPlan (automatic treatment plan generation for prostate), and AdaptBox (synthetic-CT generation from CBCT, dose computation, and replanning decision support for head/neck, breast/thorax, and male pelvis anatomies). The device is intended for use by trained medical professionals in hospitals and clinics.

ART-Plan+ v3.1.0 shares core technological features with its primary predicate (ART-Plan+ v3.0.0) and reference device (ART-Plan v2.2.0): standalone software using AI-based deep learning for automated delineation, DICOM compatibility, and CBCT-based synthetic-CT generation with dose computation on CT/synthetic-CT images for photon beam external beam irradiation. Key differences from the primary predicate include the AdaptBox module (covered by reference device), addition of new anatomical structures (ribs, cauda equina, prostate CTVn), and improved SmartPlan prescription coverage for prostate.

Not stated in this summary.

ART-Plan+ v3.1.0 is substantially equivalent because it performs the same intended functions as the predicate devices: automatic contour generation, radiotherapy treatment plan creation, and CBCT-based adaptation decision-making using identical methodologies (AI segmentation, synthetic-CT generation, dose computation). The device was validated through non-clinical performance testing including autosegmentation DSC comparison (minimum -5% tolerance), qualitative clinician evaluation (≥85% acceptance), treatment plan quantitative/qualitative assessment (≤5% DVH difference, ≥93% clinical acceptability), and synthetic-CT dosimetric validation (≥92% 2%/2mm gamma, ≥93.57% 3%/3mm gamma). All validation tests passed acceptance criteria, demonstrating clinical acceptability equivalent to predicate devices.