Clarius Median Nerve AI
Clarius Mobile Health Corp.Clarius Median Nerve AI is a machine learning-based software integrated with the Clarius Ultrasound Scanner system. It automatically segments the median nerve and measures its cross-sectional area in ultrasound images of the wrist and forearm. This tool assists trained healthcare professionals by providing semi-automated measurements to support clinical assessment in musculoskeletal ultrasound imaging, improving efficiency and accuracy while allowing manual adjustments.
Intended Use
Intended for segmentation and semi-automatic non-invasive measurements of the median nerve cross-sectional area on ultrasound data acquired by the Clarius Ultrasound Scanner (linear array scanners). Intended for use by healthcare professionals trained and qualified in ultrasound, for adult patients only.
Technology
Clarius Median Nerve AI is a deep learning segmentation algorithm integrated into the Clarius App software used with Clarius Ultrasound linear array scanners. It auto-detects and segments the median nerve in transverse ultrasound views and performs automatic cross-sectional area measurements. The clinician can manually adjust measurements. The software supports iOS and Android and operates embedded in the Clarius Ultrasound Scanner system.
Performance
Performance was established through non-clinical tests, software verification and validation, cybersecurity analysis, and clinical verification and validation studies. Clinical testing demonstrated non-inferiority of AI measurements compared to human experts in median nerve cross-sectional area measurement, with strong agreement in segmentation accuracy. Testing covered various patient demographics and multiple international clinical sites. Usability and robustness were verified, including adaptability for different ultrasound scanner models.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/27/2025
3 months - 2
FDA Approval
5/8/2025
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