Strain AI is a medical software device that analyzes cardiac ultrasound images to measure global longitudinal strain (GLS), helping clinicians assess heart function in adult patients. It integrates with existing ultrasound devices to provide quantitative strain measurements, supporting diagnostic evaluation without requiring manual interpretation of images.
Intended Use
Strain AI is intended for noninvasive processing of cardiac ultrasound images to provide measurements of global longitudinal strain of adult patients with suspected disease.
Technology
Strain AI is a software as a medical device (SaMD) that analyzes apical 4-chamber cardiac ultrasound images post-acquisition using AI, specifically deep convolutional neural networks for segmentation and landmark detection, and provides quantitative global longitudinal strain measurements.
Performance
Performance was validated on diverse clinical datasets independent from training data, from multiple clinical sites with various ultrasound devices. Accuracy was measured against a reference device using intraclass correlation coefficient (ICC) of 0.95 and root mean square difference (RMSD) of 2.76, indicating high reliability across different demographics and ultrasound machine types.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/9/2024
3 months - 2
FDA Approval
11/20/2024
Other devices from Exo Inc
- AI Platform (AIP001)2023 • 510K
- Bladder AI (AIBV01)2023 • 510K
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