Clarius Bladder AI
Clarius Mobile Health Corp.Clarius Bladder AI is a software application integrated into the Clarius Ultrasound Scanner system that uses artificial intelligence to assist healthcare professionals in semi-automatically measuring bladder volume using ultrasound images. It automates bladder detection and measurement in both sagittal and transverse views but allows users to manually adjust results, facilitating efficient and accurate bladder volume assessment in adult patients.
Intended Use
Clarius Bladder AI is intended for semi-automatic non-invasive measurements of bladder volume on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear and phased array scanners). The user shall be a healthcare professional trained and qualified in ultrasound. The user shall retain the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgment. Clarius Bladder AI is indicated for use in adult patients only.
Technology
Clarius Bladder AI is a radiological ultrasound image processing software application implementing artificial intelligence with non-adaptive machine learning algorithms incorporated into the Clarius App software. It performs automatic detection and measurement of bladder dimensions and bladder view classification (sagittal vs transverse) on ultrasound images obtained from C3 HD3 and PA HD3 transducers. The user can manually adjust caliper measurements. The software runs on iOS and Android platforms as part of the Clarius Ultrasound Scanner system and is not a standalone device.
Performance
Performance testing included verification, validation, and clinical studies demonstrating that Clarius Bladder AI's automatic bladder volume measurements are non-inferior to those performed manually by expert clinicians. Both retrospective and prospective studies with adult patients showed strong agreement with manual measurements, supported by statistical non-inferiority tests, inter-rater reliability metrics, and clinical validation confirming safety and effectiveness for intended use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/28/2023
3 months - 2
FDA Approval
11/13/2023
Other devices from Clarius Mobile Health Corp.
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