Clarius Prostate AI
Clarius Mobile Health Corp.Clarius Prostate AI is an AI-powered ultrasound software tool integrated into the Clarius Ultrasound Scanner system. It assists qualified healthcare professionals by automatically detecting, segmenting, and measuring prostate volume in ultrasound images, helping to streamline clinical workflow and improve prostate assessment accuracy while allowing manual adjustments. It is intended for adult male patients and supports prostate imaging with curvilinear and endo-cavitary scanners.
Intended Use
Intended for semi-automatic measurements of prostate volume on ultrasound data acquired by the Clarius Ultrasound Scanner for use by trained and qualified healthcare professionals.
Technology
Clarius Prostate AI is a deep learning image segmentation algorithm integrated into the Clarius App software that processes ultrasound images from specific Clarius scanner transducers (curvilinear and endo-cavitary) to segment prostate gland and automatically measure prostate dimensions (length, width, height) to calculate prostate volume. It supports manual adjustment of measurements and operates in B-mode ultrasound.
Performance
Comprehensive non-clinical and clinical performance testing was conducted, including software verification and validation per IEC 62304 and ISO 14971. Clinical verification using multi-center anonymized ultrasound images demonstrated that automated measurements by Clarius Prostate AI are non-inferior to manual measurements by expert clinicians, with strong agreement in volume accuracy and prostate view classification. Validation studies confirmed the software is safe, effective, and performs as intended for semi-automated prostate volume measurement.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/16/2024
4 months - 2
FDA Approval
4/16/2025
Other devices from Clarius Mobile Health Corp.
- Clarius Median Nerve AI2025 • 510K
- Clarius OB AI2024 • 510K
- Clarius Bladder AI2023 • 510K
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