Contour ProtégéAI

K231765

MIM Software Inc. · cleared 2023-11-08 · 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 automatically contour imaging data using machine-learning based algorithms.”
Algorithmmachine-learning based algorithms, neural network models
source quote (p.4)
“Contour ProtégéAI is an accessory to MIM software. It includes processing components to automatically contour imaging data using machine-learning based algorithms. A total of 550 CT images from 41 clinical sites across multiple continents was gathered for the training of the final 4.1.0 neural network models.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Retrospective clinical

n=754 images · 27 site(s)

endpoints: Statistical non-inferiority of the Dice score compared with the reference predicate.; Statistical non-inferiority of the MDA score compared with the reference predicate.; Cumulative Added Path Length (APL) compared to the reference predicate.; Localization accuracy of each structure.

Standalone

sample size not stated

endpoints: Average user evaluation of 2 or higher, when measured on a three-point scale.

Reported performance (1 observation)

diceas written: “Dice Contour ProtégéAI (Bone_Mandible)”0.86CI 0.83
source quote (p.13)
“Bone_Mandible 0.86 ± 0.07 (0.83) *”

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
2
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K253270 (decision 2026-03-27) from Mim Software, Inc. for a matching device line ("Contour ProtégéAI+") — a new clearance for the same line is a change event. The newer clearance's parsed summary mentions a PCCP.

    first seen 2026-07-08 · k_number:K253270

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K250035 (decision 2025-02-03) from MIM Software Inc. for a matching device line ("Contour ProtégéAI+") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K250035

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/K231765