cmTriage
K183285CureMetrix, Inc · cleared 2019-03-08 · product code QFM · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“CureMetrix's cmTriage is a radiological computer-assisted triage and notification software device.”
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. These flags are viewed by the radiologist via their Picture Archiving and Communication System (PACS) worklist. The decision to use cmTriage codes and how to use cmTriage codes is ultimately up to the radiologist. cmTriage does not send a proactive alert directly to the radiologist.”
source quote (p.5)
“This software component includes the software algorithm that is responsible for identifying and quantifying image characteristics that are consistent with a suspicious region of interest in a screening mammogram. When the software algorithm detects imaging characteristics suggestive of a suspicious region of interest, the Image Processing and Analysis Software component sets a flag in the Notification Result File indicating that the exam is "Suspicious" and sends the file back to the Image Forwarding and Result File Receiving Software. While the software algorithm informs the notification process, no other diagnostic information is generated from the algorithm or available to the user beyond the notification.”
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. Within the CureMetrix cloud, the cmTriage service receives the DICOM image(s), decrypts the image(s), groups them by study, analyzes the image(s) within the study, and produces a result for each study. The results are produced in the form of DICOM Structured Report (SR) file with a cmTriage result. The result file is encrypted and transmitted from the CureMetrix cloud back to cmEdge where it is decrypted and re-associated with the original study.”
Validation studies (1)
Retrospective clinical
n=1,255 cases
endpoints: validate that cmTriage operates at a 95% CI for both sensitivity and specificity above the 80% CI reported in the BCSC; determine time performance of cmTriage to ensure that mammograms can be processed, and notification results returned for use by radiologists within minutes which is clinically acceptable
Reported performance (3 observations)
source quote (p.8)
“Sensitivity was observed at mean of 86.9% with a 95% confidence interval (CI) of 83.6% to 90.2%.”
source quote (p.8)
“Specificity was observed at a mean of 88.5% with a 95% CI of 86.4% to 90.7%.”
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.”
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
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).