Caption Interpretation Automated Ejection Fraction Software
Caption HealthThe Caption Interpretation Automated Ejection Fraction Software is an AI-powered tool that automatically analyzes previously acquired cardiac ultrasound images to estimate the left ventricular ejection fraction. This helps clinicians assess heart function more efficiently and accurately by providing automated measurements, confidence metrics, and video clip visualizations within compatible ultrasound or PACS systems.
Intended Use
Used to process previously acquired transthoracic cardiac ultrasound images to provide automated estimation of left ventricular ejection fraction to assist clinicians in cardiac evaluation.
Technology
Machine learning algorithms are applied to previously acquired biplane apical echocardiographic ultrasound images to calculate left ventricular ejection fraction. The updated device uses expanded training data from multiple ultrasound devices and clinical sites, simplified network architecture with pooling layers and quantization, optimized image quality algorithms, and runtime speed optimizations to improve performance and efficiency.
Performance
Extensive verification and validation testing demonstrated that the device meets design requirements and is substantially equivalent to its predicate. In a retrospective validation study with 186 diverse ultrasound studies, the device measured ejection fraction with a root mean square deviation of 7.21%, showing slightly improved accuracy and comparable outlier rates compared to the predicate device, confirming safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/12/2021
10 months - 2
FDA Approval
1/19/2022
Other devices from Caption Health
- Caption Interpretation Automated Ejection Fraction Software2023 • DE NOVO
- Caption Guidance2020 • 510K
- Caption Interpretation Automated Ejection Fraction Software2020 • 510K
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