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.

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