AISAP Cardio V1.0 is an AI-powered software that analyzes cardiac point-of-care ultrasound images to detect and assess valvular pathologies like regurgitations and stenosis, and measures key cardiac functions such as ejection fraction and chamber sizes. It supports physicians by generating diagnostic reports that aid in interpreting ultrasound images, improving accuracy and efficiency in evaluating heart conditions in adult patients.
Intended Use
AISAP CARDIO V1.0 is a software platform that automatically processes and analyzes acquired cardiac POCUS images, producing a report with diagnostic assessment and measurements of several key cardiac structural and functional parameters, including presence of valvular pathology and measurements of left ventricle ejection fraction, ventricular dimensions, atrial areas, aortic and vena cava diameters. The device outputs support physicians in interpreting adult cardiac POCUS images using FDA-cleared ultrasound devices.
Technology
AISAP CARDIO V1.0 uses machine learning neural network models including classification, regression, and instance segmentation to analyze DICOM cardiac ultrasound images, automatically identifying key cardiac views and generating categorical and numeric diagnostic outputs. The software operates on off-the-shelf hardware and produces reports to aid physician diagnosis.
Performance
Performance testing includes multiple clinical studies validating structural/functional measurements and valvular pathology detection, showing high accuracy (AUC > 0.96), low error rates in measurements, and improved physician diagnostic performance when aided by the software. Studies were conducted on multi-site cohorts with diverse demographics and ultrasound devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/29/2023
7 months - 2
FDA Approval
8/1/2024
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