ART-Plan

K232479

TheraPanacea · cleared 2023-12-22 · product code MUJ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
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.”
Algorithmdeep-learning based automatic segmentation; deep-learning based synthetic CT-generation
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:”
Adaptive (vs locked)No
source quote (p.19)
“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.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (5)

Retrospective clinical

n=8,950 patients

endpoints: Dice Similarity Coefficient (DSC); clinicians' qualitative evaluation

standards: AAPM

Retrospective clinical

n=8,034 images

endpoints: median 2%/2mm gamma passing criteria; median 3%/3mm gamma passing criteria; mean dose deviation

standards: AAPM

Retrospective clinical

n=1,670 images

endpoints: median 2%/2mm gamma passing criteria; median 3%/3mm gamma passing criteria; mean dose deviation

Bench

n=272 other

endpoints: DVH or median dose deviation; median 2%/2mm gamma passing rated; median 3%/3mm gamma passing criteria

Retrospective clinical

sample size not stated

endpoints: pass the performed tests

Reported performance (6 observations)

diceas written: “Dice Similarity Coefficient (DSC) for auto-segmentation”0.8
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.”
diceas written: “Dice Similarity Coefficient (DSC) for SmartFuse (anatomical registration)”0.81
source quote (p.21)
“Dice Similarity Coefficient (DSC) of the segmented registered and non registered image is equal to or superior to the acceptance criteria set by the AAPM: DSC(mean)≥0.81”
diceas written: “Dice Similarity Coefficient (DSC) for SmartFuse (anatomical registration vs benchmark)”0.65
source quote (p.21)
“Dice Similarity Coefficient (DSC) of the segmented registered and non registered image is equal to or superior to a benchmark device: DSC(mean)≥0.65”
diceas written: “DICE diff inter-expert (Duodenum)”1.32
source quote (p.27)
“DICE diff inter-expert=1.32%”
diceas written: “DICE diff inter-expert (Large bowel)”1.19
source quote (p.27)
“DICE diff inter-expert=1.19%”
diceas written: “DICE diff inter-expert (Small bowel)”2.44
source quote (p.27)
“DICE diff inter-expert=2.44%”

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/K232479