Caption Interpretation Automated Ejection Fraction Software
Caption HealthThe Caption Interpretation Automated Ejection Fraction Software uses AI to analyze transthoracic cardiac ultrasound images and automatically estimate the left ventricular ejection fraction. This helps clinicians in cardiac evaluations by providing a consistent and efficient measurement of heart function, aiding diagnosis and treatment decisions.
Intended Use
Used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or DICOM-compliant PACS system to provide automated estimation of left ventricular ejection fraction, assisting clinicians in cardiac evaluation in adult patients.
Technology
The software applies machine learning algorithms to select image clips from cardiac ultrasound views (apical four chamber, two chamber, and parasternal long-axis), performs automated ejection fraction calculations, and outputs the ejection fraction as a percentage along with confidence metrics.
Performance
The software underwent extensive software verification and validation including algorithm performance testing on separate datasets, and clinical studies validating ejection fraction accuracy against accepted methods, meeting predefined acceptance criteria with performance comparable or superior to expert readers.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/9/2020
4 months - 2
FDA Approval
7/22/2020
Other devices from Caption Health
- Caption Interpretation Automated Ejection Fraction Software2023 • DE NOVO
- Caption Interpretation Automated Ejection Fraction Software2022 • 510K
- Caption Guidance2020 • 510K
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