cmTriage

K183285

CureMetrix, Inc · cleared 2019-03-08 · product code QFM · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“cmTriage is a software only device that can be segmented into three components: (1) Image Forwarding and Result File Receiving Software, (2) Image Processing and Analysis Software, and (3) Notification Result File.”
Algorithmartificial intelligence algorithm
source quote (p.3)
“cmTriage uses an artificial intelligence algorithm to analyze 2D FFDM screening mammograms and flags those that are suggestive of the presence of at least one suspicious finding at the exam level.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.4)
“The CureMetrix image forwarding software, acting as a PACS listener, receives a copy of the mammography DICOM image(s), creates a local copy of the image(s), de-identifies the local copy, encrypts the local copy, transmits the local copy to the CureMetrix cloud, and then deletes the local copy.”

Validation studies (1)

Retrospective clinical

n=1,255 cases

endpoints: 95% confidence interval (CI) for sensitivity and specificity; time performance

Reported performance (9 observations)

sensitivity0.869CI 83.6% to 90.2%
source quote (p.8)
“Sensitivity was observed at mean of 86.9% with a 95% confidence interval (CI) of 83.6% to 90.2%.”
specificity0.885CI 86.4% to 90.7%
source quote (p.8)
“Specificity was observed at a mean of 88.5% with a 95% CI of 86.4% to 90.7%.”
aurocas written: “auc”0.951CI 0.937 to 0.964
source quote (p.8)
“Overall cmTriage was able to demonstrate an area under the curve (AUC) of 0.951 with a 95% CI of 0.937 to 0.964 on this dataset.”
aurocas written: “AUC for Density 1”0.964CI 0.934 to 0.994
source quote (p.8)
“Density 1: AUC 0.964 with a 95% CI of 0.934 to 0.994”
aurocas written: “AUC for Density 2”0.964CI 0.946 to 0.981
source quote (p.8)
“Density 2: AUC 0.964 with a 95% CI of 0.946 to 0.981”
aurocas written: “AUC for Density 3”0.94CI 0.917 to 0.963
source quote (p.8)
“Density 3: AUC 0.940 with a 95% CI of 0.917 to 0.963”
aurocas written: “AUC for Density 4”0.958CI 0.92 to 0.995
source quote (p.8)
“Density 4: AUC 0.958 with a 95% CI of 0.92 to 0.995”
aurocas written: “AUC for Mass lesion type”0.941CI 0.923 to 0.959
source quote (p.8)
“Mass: AUC 0.941 with a 95% CI of 0.923 to 0.959”
aurocas written: “AUC for Calcifications lesion type”0.972CI 0.958 to 0.985
source quote (p.8)
“Calcifications: AUC 0.972 with a 95% CI of 0.958 to 0.985”

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/K183285