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Caption Interpretation Automated Ejection Fraction Software

Caption Health, Inc • Radiology • 02/24/2023

De NovoIEC 62304 Class B
FDA Summary PDF

Device Purpose

Caption AutoEF is an AI-driven software that utilizes deep learning, specifically convolutional neural networks, to automate the calculation of left ventricular ejection fraction from standard echocardiogram clips by identifying apical views and segmenting the left ventricle. This technology aims to enhance cardiac assessment by providing rapid, accurate LVEF measurements, thereby streamlining clinical workflows and reducing interobserver variability in echocardiographic interpretation.

Summary

Caption AutoEF is an innovative AI software engineered to automate the crucial calculation of left ventricular ejection fraction (LVEF) derived from standard transthoracic echocardiogram clips. Its core methodology involves leveraging advanced deep learning algorithms to meticulously identify apical views and perform frame-by-frame segmentation of the left ventricle's endocardium. This automated process circumvents the need for laborious manual tracing, directly computing and delivering a quantitative ejection fraction to significantly aid cardiologists in their diagnostic assessments of cardiac function. The scientific foundation of AutoEF lies in its sophisticated convolutional neural networks, which were rigorously developed and then locked prior to extensive validation to ensure unbiased performance evaluation. Clinical testing has substantiated its efficacy, demonstrating a high degree of agreement with LVEF measurements performed by expert cardiologists. By integrating seamlessly into existing post-processing workflows, Caption AutoEF not only streamlines the overall echo reporting process but also critically contributes to reducing interobserver variability, thereby fostering more consistent and reliable cardiac assessments.

AI Regulatory Concerns

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

Keywords

Caption AutoEFAI softwaredeep learningleft ventricular ejection fractionLVEFtransthoracic echocardiogramapical viewsleft ventricle segmentationconvolutional neural networksinterobserver variability

Device Metadata

Submission Number
DEN220063
Company
Caption Health, 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 was the specific dataset size and diversity used for training and validating the convolutional neural networks in Caption AutoEF?; How does Caption AutoEF's performance compare to other automated LVEF quantification tools in terms of accuracy, processing time, and robustness across different image qualities?; What is the impact of varying echocardiogram image quality or atypical cardiac anatomies on the accuracy of Caption AutoEF's LVEF calculations?; Beyond LVEF, are there plans to extend Caption AutoEF's capabilities to quantify other echocardiographic parameters or identify other cardiac abnormalities?; How does the integration of Caption AutoEF into clinical workflows specifically affect patient throughput and the time to diagnosis in real-world cardiology practice?

Risk Classification

ESL Analysis
FDA Device ClassII

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

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Cybersecurity Evidence

Powered by SBOMator™

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 Score25/100
SBOM Evidence⚠ Not mentioned in summary
Cyber Risk Assessment⚠ Not mentioned in summary
Postmarket Plan✓ Detected 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(deep learning, neural network, algorithm, dataset, bias)
✓ Detected
SaaSBOMSoftware-as-a-Service Bill of Materials(server, network)
✓ 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, SaaSBOM detected in AI-generated device summary.

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

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

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Caption Interpretation Automated Ejection Fraction Software - Caption Health, Inc | ESL FDA AI Device Intelligence