Caption Interpretation Automated Ejection Fraction Software
Caption Health • Radiology • 01/19/2022
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.
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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 AnalysisFDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Authorized before §524B enforcement
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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.
Supply Chain BOM Evidence
Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.
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.
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