Clarius OB AI
Clarius Mobile Health Corp.Clarius OB AI is an AI-powered software integrated into the Clarius Ultrasound system that assists healthcare professionals in measuring fetal biometric parameters such as head circumference and femur length using ultrasound images. It automates the detection and measurement process, helping clinicians make accurate assessments during obstetric ultrasound examinations.
Intended Use
Clarius OB AI is intended to assist in measurements of fetal biometric parameters (i.e., head circumference, abdominal circumference, femur length, bi-parietal diameter, crown rump length) on ultrasound data acquired by the Clarius Ultrasound Scanner. The user shall be a healthcare professional trained and qualified in ultrasound. The user retains responsibility for confirming the validity of measurements based on standard practices and clinical judgment. The device is indicated for use in adult patients only.
Technology
Clarius OB AI is a machine learning algorithm integrated into the Clarius App software and ultrasound system, which automatically detects and measures fetal biometric parameters using deep learning image segmentation applied to B-mode ultrasound images from a curvilinear transducer. It is compatible with iOS and Android systems and allows manual adjustment of measurements by trained users.
Performance
Performance testing included verification and validation through retrospective analysis of 347 fetal ultrasound images from 25 clinical sites worldwide. The AI measurements were non-inferior to manual expert measurements, showing strong correlation (ICC of 0.99). Clinical validation confirmed usability and measurement accuracy, supporting safe and effective semi-automated fetal biometric measurements.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/15/2023
6 months - 2
FDA Approval
6/14/2024
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