ART-Plan (v.2.2.0)
K234068Therapanacea SAS · cleared 2024-04-22 · product code MUJ · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“ART-Plan is a software platform allowing users with an account to contour regions of interest on 3D images, perform multi-model registration of images, and help in the decision for the need for replanning based on contours and doses on daily images.”
source quote (p.6)
“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: Both devices allow automatic segmentation on medical images using AI algorithms”
Validation studies (8)
Retrospective clinical
n=17 patients
endpoints: Mean DSC should not regress negatively between the current and last validated version of Annotate beyond a maximum tolerance margin set to -5% relative error.
Retrospective clinical
n=17 patients
endpoints: The Dice Similarity Coefficient (DSC) is equal to or superior to the acceptance criteria set by the AAPM: DSC (mean)≥ 0.8.; The Hausdorff distance 95th percentile (HD95) is equal to or inferior to the acceptance criteria set HD95 (mean) ≤ 5.75 mm.
Retrospective clinical
n=17 patients
endpoints: The Dice Similarity Coefficient (DSC) is equal to or superior to the acceptance criteria set by the AAPM: DSC (mean)≥ 0.8.; The Hausdorff distance 95th percentile (HD95) is equal to or inferior to the acceptance criteria set HD95 (mean) ≤ 5.75 mm.; Mean DSC (US) ≥Mean DSC (nUS); Mean HD95(US) ≤ Mean HD95 (nUS)
Retrospective clinical
n=15 patients
endpoints: The clinicians' qualitative evaluation of the auto-segmentation is considered acceptable for clinical use without modifications (A) or with minor modifications / corrections (B) with a A+B % above or equal to 85% considering the following scale: A. the contour is acceptable for a clinical use without any modification B. the contour would be acceptable for clinical use after minor modifications/corrections C. the contour requires major modifications (e.g. it would be faster for the expert to manually delineate the structure)
Retrospective clinical
n=15 patients
endpoints: The clinicians' s qualitative evaluation of the propagated contours post-registration are considered acceptable for clinical use without modifications (A) or with minor modifications / corrections (B) with a A+B % above or equal to 85% for deformable and above or equal to 50% for rigid registration considering the following scale: A. the contour is acceptable for a clinical use without any modification B. the contour would be acceptable for clinical use after minor modifications/corrections C. the contour requires major modifications (e.g. it would be faster for the expert to manually delineate the structure)
Retrospective clinical
n=19 patients
endpoints: DVH parameters (PTV): < 2%; DVH Individual Pass Rates (PTV): > 76.7%; Median Gamma Index 2%/2mm: ≥ 92%; Median Gamma Index 3%/3mm: ≥ 93.57%
Retrospective clinical
n=19 patients
endpoints: Jacobian Determinant = 1 +/- 5%
Retrospective clinical
n=45 patients
endpoints: Relative differences on DVH parameters (PTV/OARs): ≤ 4.4% (with some superior individual values); for Lungs ≤ 24.4%; Median Gamma Index 2%/2mm (with different thresholds): ≥ 86.3%; Median Gamma Index 3%/3mm (with different thresholds): ≥ 91.75%
Reported performance (4 observations)
source quote (p.8)
“The Dice Similarity Coefficient (DSC) is equal to or superior to the acceptance criteria set by the AAPM: DSC (mean)≥ 0.8.”
source quote (p.8)
“The Dice Similarity Coefficient (DSC) is equal to or superior to inter-expert variability: DSC (mean)≥ 0.54 or DSC (mean) ≥ mean (DSC inter-expert) + 5%.”
source quote (p.8)
“Mean DSC should not regress negatively between the current and last validated version of Annotate beyond a maximum tolerance margin set to -5% relative error.”
source quote (p.9)
“Mean DSC (US) ≥Mean DSC (nUS)”
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K242822 (decision 2025-02-25) from Therapanacea SAS for a matching device line ("ART-Plan+ (v.3.0.0)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K242822
- 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).