Contour ProtegeAI

K210632

MIM Software Inc. · cleared 2021-10-20 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Contour ProtégéAI is an accessory to MIM software. It includes processing components to allow the contouring of anatomical structures using machine-learning-based algorithms automatically.”
Algorithmmachine-learning-based algorithms, neural network models
source quote (p.4)
“It includes processing components to allow the contouring of anatomical structures using machine-learning-based algorithms automatically. new and modified CT neural network models with additional contours, a modified Prostate MR neural network model”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

sample size not stated

endpoints: Dice coefficient

Reported performance (1 observation)

diceas written: “Dice coefficient”stated without valueCI lower 95th percentile confidence bound
source quote (p.10)
“The mean and standard deviation Dice coefficients, along with the lower 95th percentile confidence bound, were calculated for both the proposed Contour ProtégéAI device and the MIM Maestro atlas segmentation reference device for each structure of each neural network model. Contour ProtégéAI results were equivalent or had better performance than the MIM atlas segmentation reference device. Equivalence is defined such that the lower 95th percentile confidence bound of the Contour ProtégéAI segmentation is greater than 0.1 Dice lower than the mean MIM Maestro atlas segmentation reference device performance.”

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

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/K210632