Medscape Medical NewsAll articles

Caption Interpretation Automated Ejection Fraction Software

Caption Health • Radiology • 01/19/2022

510(k)IEC 62304 Class B
FDA Summary PDF

Device Purpose

The Caption Interpretation Automated Ejection Fraction Software utilizes machine learning algorithms to automatically calculate left ventricular ejection fraction from previously acquired transthoracic cardiac ultrasound images, providing clinicians with a quantitative assessment for cardiac evaluation. This updated version enhances performance and efficiency through algorithm retraining with expanded datasets, simplified network architecture, and optimized image processing, validated by achieving improved accuracy in retrospective studies.

Summary

The Caption Interpretation Automated Ejection Fraction Software is a medical image management and processing system designed to assist clinicians in cardiac evaluations of adult patients. It processes previously acquired transthoracic cardiac ultrasound images (DICOM clips) using machine learning algorithms to automatically estimate left ventricular ejection fraction (LVEF). The software operates on various platforms, including ultrasound devices, personal computers, or compatible DICOM-compliant PACS systems, and can store, manipulate, and allow measurements on these images. It automatically selects relevant image clips from apical four-chamber, apical two-chamber, or a combination of parasternal long-axis with apical views, calculates the LVEF as a percentage, and provides a confidence metric to the clinician. This updated version of the software maintains the core machine learning-based approach for EF calculation from biplane apical echocardiographic images but incorporates several technological enhancements. These include retraining its algorithms with an additional 30% more data from diverse ultrasound devices and clinical sites, simplifying its network architecture with simple pooling layers and quantization, and using linear support vector machines for image quality algorithms. These changes aim to improve performance across varied devices and patient types, reduce computational complexity for faster operation, and maintain clinical efficacy. Performance was validated in a retrospective study of over 186 studies, demonstrating a Root Mean Square Deviation (RMSD) of 7.21 EF% against biplane method ground truth, a slight improvement over its predicate, with comparable outlier rates.

AI Regulatory Concerns

Powered byJev by TypeSafe AI

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

Keywords

Automated Ejection FractionMachine LearningEchocardiographyLeft Ventricular Ejection Fraction (LVEF)Cardiac UltrasoundImage Processing SoftwareDICOMApical ViewsRetrospective ValidationAlgorithm Retraining

Device Metadata

Submission Number
K210747
Company
Caption Health
Panel
Radiology
Product Code
N/A
Data Type
Images
Clinical Function
Assessment
AI Function
Analysis
AI Subclass
quantification/feature localization

Relevant Clinical Questions

  • Q1. How does the simplified network architecture (simple pooling, quantization) and linear SVM impact the algorithm's robustness to variations in image quality or atypical cardiac anatomy not extensively represented in the expanded training dataset?; What specific patient demographics or cardiac conditions, if any, showed the most significant improvement or continued challenges in LVEF accuracy with the retrained algorithms and optimized image quality thresholds?; Given the runtime speed optimization, what is the typical processing time for an LVEF estimation on standard computing hardware, and how does this compare to the previous version under similar conditions?; How does the "confidence metric" provided with the LVEF estimate correlate with the actual error rates, and what specific factors most influence a lower confidence score?; Beyond RMSD, were there any secondary performance metrics evaluated, such as inter-operator variability if human clip selection was compared, or performance in specific LVEF ranges (e.g., severely reduced, borderline)?

Risk Classification

ESL Analysis
FDA Device ClassII

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

Learn how Parasoft automates IEC 62304 compliance testing →

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 Score20/100
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, machine learning, algorithm, dataset, ground truth)
✓ Detected
SaaSBOMSoftware-as-a-Service Bill of Materials(network, platform)
✓ Detected
HBOMHardware Bill of Materials(hardware)
✓ Detected
CBOMCryptography Bill of Materials
- Not detected
VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange
- Not detected
OBOMOperations Bill of Materials(runtime)
✓ 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, HBOM, OBOM 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, CBOM, VDR/VEX. These may be present in the full FDA submission.

Preparing a similar submission?

ESL takes complete ownership of your software evidence work - SBOM & CVE remediation with SBOMator™, static analysis & unit testing with Parasoft, traceability, and full IEC 62304 lifecycle support.

Assess Your Readiness →Or contact ESL directly
Caption Interpretation Automated Ejection Fraction Software - Caption Health | ESL FDA AI Device Intelligence