ART-Plan+ (v.3.0.0)

ART-Plan+ is a deep-learning based software designed to automate medical charged-particle radiation therapy planning by performing automatic segmentation of anatomical structures and generating treatment plans. Its substantial equivalence was confirmed through non-clinical testing demonstrating clinical acceptability of its autosegmentation performance and automatic plan generation, aiming to enhance efficiency and consistency in clinical radiotherapy.

Therapanacea SAS has received a substantial equivalence determination for their ART-Plan+ (v.3.0.0) software, classifying it as a Class II medical charged-particle radiation therapy system. This regulatory approval, issued on February 25, 2025, allows the device to be marketed, subject to general controls and additional regulations applicable to its classification. ART-Plan+ is a software platform that leverages deep learning for automatic segmentation of organs at risk, lymph nodes, and targets on 3D CT and MR images across various body regions. It also features a SmartPlan module for the automatic generation of radiotherapy treatment plans, primarily for prostate treatments, which can then be imported into existing Treatment Planning Systems. Intended for trained medical professionals, the software's clinical acceptability was confirmed through comprehensive non-clinical testing, including evaluations of autosegmentation performance, inter-expert variability, and automatic plan generation, validating its equivalence to a legally marketed predicate device.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What are the specific deep-learning models or architectures used for the automatic segmentation, and how were they trained and validated for diverse patient populations and imaging modalities?; Beyond prostate treatments, what is the current or planned scope for SmartPlan's automatic treatment generation capabilities across other body sites and radiation therapy modalities?; How does ART-Plan+ quantify and mitigate uncertainties associated with its automatic segmentation and treatment planning, especially in anatomically challenging regions or for complex disease sites?; What are the long-term clinical outcomes or real-world effectiveness studies available for treatment plans generated by ART-Plan+, particularly concerning dose distribution accuracy and patient safety?; What quality assurance protocols and user-interface features are in place to allow clinicians to review, modify, and ensure the safety and efficacy of automatically generated contours and plans?