Clarius AI
Clarius Mobile Health Corp.Clarius AI is software integrated with the Clarius Ultrasound Scanner that uses artificial intelligence to semi-automatically measure tendon thickness on ultrasound images of musculoskeletal structures such as the Achilles’ tendon and patellar tendon. It helps healthcare professionals by segmenting ultrasound images and automatically placing measurement calipers, streamlining the quantification process while allowing manual adjustment by trained clinicians.
Intended Use
Clarius AI is intended to semi-automatically place calipers for non-invasive measurements of musculoskeletal structures (e.g., Achilles’ tendon, plantar fascia, patellar tendon) on ultrasound data acquired by the Clarius Ultrasound Scanner. The user shall be a healthcare professional trained and qualified in musculoskeletal ultrasound.
Technology
Clarius AI utilizes an AI image segmentation algorithm based on non-adaptive machine learning (Exception U-Net architecture) to analyze ultrasound images in real-time for tendon segmentation and thickness measurement, placing adjustable calipers on the thickest region of tendons. It is incorporated into the Clarius App software and operates with Clarius Ultrasound Scanner transducers L7 and L15.
Performance
Performance testing included AI model training on a large dataset of annotated ultrasound images, achieving a high average Dice score of 96%. Verification studies demonstrated that AI measurements of tendon thickness were statistically non-inferior to manual measurements by experienced clinicians, with an equivalence margin of 20%. Validation testing confirmed clinical usability and fulfillment of user needs for semi-automatic caliper placement with manual adjustment.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/9/2022
5 months - 2
FDA Approval
1/23/2023
Other devices from Clarius Mobile Health Corp.
- Clarius OB AI2024 • 510K
- Clarius Bladder AI2023 • 510K
- Clarius Ultrasound Scanner2023 • 510K
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