ART-Plan
K232479TheraPanacea · cleared 2023-12-22 · product code MUJ · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“ART-Plan is a software intended to be used by trained clinicians who are familiar with radiation therapy, such as medical physicists, medical dosimetrists and radiation oncologists. The software consists of different applications, each used for specific purposes at a different phase of radiation treatment planning.”
source quote (p.19)
“ART-Plan offers deep-learning based automatic segmentation for the following localizations: ... ART-Plan offers deep-learning based synthetic CT-generation from MR images for the following localizations: ... ART-Plan offers deep-learning based synthetic CT-generation from CBCT images for the following localizations:”
source quote (p.20)
“Our curves show that validation and training data are very close to each other, reaching convergence after some epochs (depending on the structure), demonstrating no overfitting of the training data. Once convergence is achieved, the model is considered ready to be tested and clinically validated on a different, yet representative data set, following a well-established process of validation that has already been submitted to and cleared by the FDA.”
Validation studies (3)
Retrospective clinical
n=38 cases
endpoints: Dice Similarity Coefficient (DSC); qualitative evaluation (A+B%)
standards: AAPM
Retrospective clinical
n=45 cases
endpoints: Gamma passing criteria; mean dose deviation
standards: AAPM
Retrospective clinical
n=272 patients
endpoints: Gamma index; DVH parameters (PTV); DVH parameters (OARs)
Reported performance (1 observation)
source quote (p.21)
“The Dice Similarity Coefficient (DSC) is equal to or superior to the acceptance criteria set by the AAPM: DSC (mean)≥ 0.8.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- recall_reason_pattern
Software/algorithm-related recall in product code MUJ (Philips Medical Systems (Cleveland) Inc, initiated 2025-08-05): "Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet Firs" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97049
- recall_reason_pattern
Software/algorithm-related recall in product code MUJ (Philips Medical Systems (Cleveland) Inc, initiated 2025-07-17): "Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ," Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97309
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).