ART-Plan+ (v.3.0.0)
K242822Therapanacea SAS · cleared 2025-02-25 · product code MUJ · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“ART-Plan+ is a software platform allowing contour regions of interest on 3D images and to provide an automatic treatment plan.”
source quote (p.6)
“ART-Plan+ offers deep-learning based automatic segmentation of OARs and LNs for the following localizations: -Head and neck (on CT images) -Thorax/breast (on CT images) -Abdomen (on CT and male on MR images) -Pelvis male (on CT and MR images) -Pelvis female (on CT images) -Brain (on CT images and MR images) ART-Plan+ offers deep-learning based automatic segmentation of targets for the following localizations: Deep learning algorithm. The proposed device and primary predicate share an AI delineation method.”
Validation studies (7)
Retrospective clinical
n=24 patients
endpoints: DSC
Retrospective clinical
n=18 patients
endpoints: clinical acceptability (A, B, C scale)
Retrospective clinical
n=24 patients
endpoints: Mean DSC
Reader study (MRMC)
n=13 patients
endpoints: Mean DSC (annotate) vs Mean DSC (inter-expert)
Retrospective clinical
n=51 patients
endpoints: lesion-wise sensitivity; lesion-wise precision; lesion-wise DSC similarity coefficient; patient-wise DSC similarity coefficient; patient-wise false positive
Retrospective clinical
n=43 patients
endpoints: sensitivity; DSC
Retrospective clinical
n=20 patients
endpoints: effectiveness difference (%) in DVH achieved goals between manual plans and automatic plans; % of clinical acceptable automatic plans after expert review
Reported performance (6 observations)
source quote (p.10)
“The lesion-wise sensitivity is equal to or superior to state-of-the-art as benchmark: mean lesion-wise sensitivity ≥ 0.86”
source quote (p.10)
“The lesion-wise precision is equal to or superior to state-of-the-art as benchmark: mean lesion-wise precision ≥ 0.70”
source quote (p.10)
“The lesion-wise DSC similarity coefficient (DSC) is equal to or superior to state-of-the-art as benchmark: mean lesion-wise DSC ≥ 0.78”
source quote (p.10)
“The patient-wise DSC similarity coefficient (DSC) is equal to or superior to state-of-the-art as benchmark: mean patient-wise DSC ≥ 0.83”
source quote (p.10)
“The sensitivity is equal to or superior to state-of-the-art as benchmark: mean sensitivity ≥ 0.80”
source quote (p.10)
“The DSC is equal to or superior to state-of-the-art as benchmark: mean DSC ≥ 0.76”
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K253091 (decision 2025-12-23) from Therapanacea Sas for a matching device line ("ART-Plan+ (v3.1.0)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K253091
- 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).