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The Stone Clear ultrasonic propulsion device is indicated for the repositioning of residual stone fragments post-lithotripsy that are located in the upper urinary tract of adult patients to facilitate passage, where any individual fragment is less than or equal to 5 mm.

The Stone Clear device consists of a commercially available third-party diagnostic ultrasound imaging unit (GE LOGIQ P9, K181783, Imaging Workstation) that is integrated with a SonoMotion-manufactured signal generator and therapy probe.

The Imaging Workstation and associated ultrasound imaging provide the user interface and real-time image guidance for the Stone Clear procedure, while the Generator controls and drives the Therapy Probe. The Therapy Probe delivers the ultrasound pulses to reposition stones. The Imaging Probe and Therapy Probe are coaxially aligned, with the Imaging Probe docking into the housing of the Therapy Probe through an adapter. A foot pedal is used to initiate the therapy from the Generator.

The provided text describes the regulatory information, device description, nonclinical/bench studies, and clinical information (including results and benefit-risk determination) for the Stone Clear ultrasonic urinary stone propulsion device.

However, the provided text does not contain any information about acceptance criteria or a study design to prove that an AI/ML algorithm meets acceptance criteria. The "Stone Clear" device is a physical medical device, not an AI/ML algorithm. The "Software" section primarily describes the device's control firmware and user interface, without any indication of AI/ML components for classification, prediction, or diagnostic assistance.

Therefore, I cannot fulfill the request as it asks for information that is not present in the provided input text. The prompt's questions pertain to acceptance criteria and studies for AI/ML performance (e.g., sample size for test/training sets, data provenance, expert labeling, MRMC studies, standalone performance, ground truth establishment), which are irrelevant to the description of the Stone Clear device.

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