ART-Plan+ (v.3.0.0)

ART-Plan+ is a software platform for cancer radiotherapy planning that automatically contours organs at risk, lymph nodes, and tumors on CT and MR images using deep learning algorithms. It also generates automatic radiotherapy treatment plans for prostate cancer that users import into their own Treatment Planning System for dose calculation, review, and approval. The device is intended for use by trained medical professionals in hospitals and clinics treating patients 18 years and older.

Both ART-Plan+ and the predicate (Radiation Planning Assistant) use AI-based delineation methods for automatic contouring of regions of interest. ART-Plan+ offers deep-learning segmentation across multiple anatomical sites (head/neck, thorax, abdomen, pelvis, brain) on both CT and MR images, while the predicate provides autocontouring for a range of structures. Both devices allow creation of contours and treatment plans that users import into their own Treatment Planning System for dose calculation and approval.

Not stated in this summary.

ART-Plan+ is substantially equivalent because it performs the same intended functions as the predicate using the same AI-based approach: both enable external beam radiotherapy planning with photon beams using CT images, both automatically contour regions of interest, and both allow users to export plans for independent dose calculation. The device was validated through non-regression testing (DSC ≥0.8 for new organs, no more than -5% regression for existing structures), qualitative expert review (≥85% acceptable), inter-expert variability comparison (≥Mean DSC inter-expert with -5% tolerance), and clinical plan acceptability (≥93% of automatic plans clinically acceptable). All validation datasets were representative of worldwide radiotherapy populations, and all acceptance criteria were met, demonstrating that ART-Plan+ performs equivalently to the predicate with no additional claims or risks.