cmAngio® V1.0

CureMetrix, Inc. • Radiology • 10/05/2023

510(k)IEC 62304 Class B

Device Purpose

cmAngio® V1.0 is a prescription-only artificial intelligence software designed to process both FFDM and DBT screening mammograms, assisting qualified physicians by automatically detecting and marking Breast Arterial Calcification. This system functions as an adjunctive tool to enhance the identification of this incidental finding within the standard mammography workflow, without being intended for primary cancer diagnosis or standalone diagnostic decisions.

Summary

cmAngio® V1.0 is a software device utilizing proprietary artificial intelligence to process screening mammograms, specifically Full Field Digital Mammograms (FFDM) and Digital Breast Tomosynthesis (DBT) images. Its primary purpose is to aid qualified interpreting physicians in the identification of Breast Arterial Calcification (BAC), which is considered an incidental finding. The software works by detecting the presence or absence of BAC at both the overall study level and the individual breast level. Furthermore, it enhances the visualization process by marking BAC segments on thumbnail representations of the mammographic images, thereby assisting in the localization of these calcifications. The cmAngio® V1.0 software is designed for use by qualified interpreting physicians as an adjunctive tool within the existing breast screening mammography workflow. It is important to note that the device is not intended for the primary interpretation of digital mammography images concerning breast cancer detection. Consequently, it should not be used in isolation to make any diagnostic or treatment decisions. cmAngio® V1.0 is available for prescription use only and aims to support clinicians by improving the detection of BAC, which can be indicative of other health considerations.

AI Regulatory Concerns

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

Keywords

Breast Arterial CalcificationArtificial IntelligenceMammographyScreeningImage ProcessingFFDMDBTIncidental FindingPhysician AidLocalization

Device Metadata

Submission Number

K232367

Company

CureMetrix, Inc.

Panel

Radiology

Product Code

N/A

Data Type

Images

Clinical Function

Assessment

AI Function

Analysis

AI Subclass

quantification/feature localization

Relevant Clinical Questions

Q1. What is the standalone performance (sensitivity, specificity, accuracy) of cmAngio® V1.0 in detecting and localizing Breast Arterial Calcification across diverse patient populations and varying image qualities for both FFDM and DBT modalities?; How does the integration of cmAngio® V1.0 into the standard mammography reading workflow affect the interpreting physician's efficiency, diagnostic confidence for BAC, and overall report turnaround time?; What are the specific features or characteristics of the AI algorithm used in cmAngio® V1.0, including details about its training dataset, validation methods, and its robustness against common image artifacts or atypical BAC presentations?; Beyond simple detection and localization, does cmAngio® V1.0 offer any quantitative assessment of BAC (e.g., extent, density), and how might such quantitative data correlate with cardiovascular risk or other clinical outcomes?; What studies have been conducted to evaluate the clinical utility and impact of cmAngio® V1.0, specifically regarding changes in patient management or follow-up recommendations based on BAC findings highlighted by the software?

Risk Classification

ESL Analysis

IEC 62304 ClassB

FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Authorized before §524B enforcement

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Cybersecurity Evidence

Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.

Cyber Score5/100

SBOM Evidence⚠ Not mentioned in summary

Cyber Risk Assessment⚠ Not mentioned in summary

Postmarket Plan⚠ Not mentioned in summary

§524B ApplicableNo

Supply Chain BOM Evidence

Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.

SBOMSoftware Bill of Materials

- Not detected

ML-BOMMachine Learning Bill of Materials(training data, algorithm, dataset)

✓ Detected

SaaSBOMSoftware-as-a-Service Bill of Materials

- Not detected

HBOMHardware Bill of Materials

- Not detected

CBOMCryptography Bill of Materials

- Not detected

VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange

- Not detected

OBOMOperations Bill of Materials

- Not detected

Analysis:

• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.

• Evidence of ML-BOM detected in AI-generated device summary.

• This device was authorized before §524B took effect. Cybersecurity evidence requirements were less prescriptive at the time.

• Postmarket cybersecurity monitoring plan not clearly documented in AI-generated device summary.

• Not detected in AI-generated device summary: SBOM, SaaSBOM, HBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.

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