AVA (Augmented Vascular Analysis)
See-Mode Technologies Pte. Ltd.AVA (Augmented Vascular Analysis) by See-Mode Technologies is a software that uses artificial intelligence to analyze vascular ultrasound images from carotid and lower limb arteries. It segments vessel walls, measures carotid intima-media thickness, reads Doppler velocities, and generates detailed vascular ultrasound reports to aid clinicians like physicians and medical technicians in assessing cardiovascular health. The software runs on standard computers or cloud platforms and supports quality control by qualified clinicians to ensure accuracy.
Intended Use
Analysis and reporting of vascular ultrasound images.
Technology
Standalone software runs on standard desktop/laptop or cloud platform, analyzing DICOM-compliant vascular ultrasound images using proprietary algorithms incorporating artificial intelligence and machine learning methods for segmentation, intima-media thickness measurement, Doppler velocity analysis, and annotation reading to generate vascular ultrasound reports.
Performance
Performance evaluated on retrospective multi-center datasets showed strong correlation with expert readers for carotid IMT measurement (correlation coefficient 0.89 vs experts' 0.86 and predicate 0.6), text recognition accuracy 92-96%, and high correlation for Doppler peak systolic and end diastolic velocities (0.98 and 0.97), with waveform classification accuracy of 93%. Risk analysis shows all risks mitigated and acceptable. Overall performance and safety comparable or superior to predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/22/2020
3 months - 2
FDA Approval
9/16/2020
Other devices from See-Mode Technologies Pte. Ltd.
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