ART-Plan+ (v3.1.0)

K253091

Therapanacea Sas · cleared 2025-12-23 · product code MUJ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.9)
“Standalone software application accessed via a compliant browser (Chrome, Mozilla Firefox and Edge) on a personal computer, tablet or phone (In case of connection to the platform with a screen of a phone or a tablet, the user must choose the option for the desktop site of his communication device. The platform is optimally used with 17 inches and up screen. Facilitates display and visualization of data by user.”
AlgorithmDeep learning algorithm; AI (deep learning neural networks)
source quote (p.9)
“AI (deep learning neural networks) and Deep learning algorithm.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (8)

Retrospective clinical

n=24 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=24 patients

endpoints: Mean DSC (SCT) should be equivalent to Mean DSC (CT) beyond a maximum tolerance margin set to -5% relative error.

Retrospective clinical

n=18 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=24 patients

endpoints: Mean DSC (annotate) ≥ 0.8

Retrospective clinical

n=20 patients

endpoints: Quantitative evaluation: effectiveness difference (%) in DVH achieved goals between manual plans and automatic plans ≤ 5%; Qualitative evaluation: % of clinical acceptable automatic plans ≥ 93% after expert review.

Retrospective clinical

n=15 patients

endpoints: Median 2%/2mm ≥ 92%; Median 3%/3mm ≥ 93.57%; A median dose deviation (synthetic-CT compared to standard CT) of ≤2% in 276.7% of patients

Retrospective clinical

n=15 patients

endpoints: Jacobian determinant = 1 +/- 5%

Retrospective clinical

n=10 patients

endpoints: The clinicians' qualitative evaluation of the overall registration output following clinical protocols to qualitatively assess registration outcomes is considered acceptable for clinical use with A+B% above or equal to 85% for deformable considering the following scale: A. The registration exceeds the expectation B. The registration meets the expectation (incl. cases for which additional margin may be required or registration might be relaunched using different supporting tools) C. The registration is not acceptable

Reported performance (3 observations)

diceas written: “Mean DSC (Annotate non-regression)”stated without value
source quote (p.12)
“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.”
diceas written: “Mean DSC (SCT vs CT)”stated without value
source quote (p.12)
“Mean DSC (SCT) should be equivalent to Mean DSC (CT) beyond a maximum tolerance margin set to -5% relative error.”
diceas written: “Mean DSC (Annotate quantitative)”0.8
source quote (p.12)
“Mean DSC (annotate) ≥ 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

35
recalls in product code, 24mo
17
MAUDE reports in code, 12mo
-50%
vs code's own 3-yr baseline
2
drift signals on this device
  • 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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K253091