CogNet QmTRIAGE

K220080

MedCognetics, Inc. · cleared 2022-09-29 · product code QFM · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“The MedCognetics (CogNet) QmTRIAGE is a non-invasive computer-assisted triage and notification software as a medical device (SaMD) that analyzes 2D FFDM screening mammograms using a machine learning algorithm”
Algorithmmachine learning algorithm
source quote (p.4)
“The MedCognetics (CogNet) QmTRIAGE is a non-invasive computer-assisted triage and notification software as a medical device (SaMD) that analyzes 2D FFDM screening mammograms using a machine 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 (1)

Retrospective clinical

n=800 cases

endpoints: overall Area Under Receiver Operating Characteristics (AUROC); Sensitivity; Specificity

Reported performance (3 observations)

sensitivity0.87
source quote (p.6)
“Also validated was Sensitivity and Specificity, achieving an overall Sensitivity of 87% and a Specificity of 89% across the entire test dataset, without subgroup breakdown, which exceeded the standard of care as reported in the Breast Cancer Surveillance Consortium (BCSC) study.”
specificity0.89
source quote (p.6)
“Also validated was Sensitivity and Specificity, achieving an overall Sensitivity of 87% and a Specificity of 89% across the entire test dataset, without subgroup breakdown, which exceeded the standard of care as reported in the Breast Cancer Surveillance Consortium (BCSC) study.”
aurocas written: “auc”0.9569CI 0.9364-0.9738
source quote (p.6)
“The validation of the performance of MedCognetics' QmTRIAGE algorithm for triage of 2D FFDM achieved an overall Area Under Receiver Operating Characteristics (AUROC) of 0.9569 with 95% CI: 0.9364-0.9738 across the entire test dataset, without subgroup breakdown.”

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
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K252482 (decision 2025-12-11) from Medcognetics, Inc. for a matching device line ("CogNet AI-MT+") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K252482

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/K220080