Contour ProtegeAI

K210632

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

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems.”

Algorithmmachine-learning-based algorithms

source quote (p.4)

“It includes processing components to allow the contouring of anatomical structures using machine-learning-based algorithms automatically.”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

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).