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The Break Wave device is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper and lower ureter).

The Break Wave device is designed for the extracorporeal fragmentation of calculi located in the kidney and ureter. The primary components include a diagnostic ultrasound imaging workstation, imaging probe(s), high voltage signal generator, and piezoelectric acoustic source (therapy probe).

The generator controls and drives the therapy probe, which delivers the acoustic pulses required for breaking stones. A lens is used to focus the acoustic waves to the target stone, creating stresses within the stone that result in stone fracture. Repeated application of the acoustic waves breaks the stone into small fragments that can pass spontaneously.

The imaging workstation and associated ultrasound imaging probe provide the user interface and real-time image guidance for the Break Wave procedure. The imaging and therapy probe are coaxially aligned, with the imaging probe docking into the housing of the therapy probe. The probe assembly is designed to couple directly to the patient's skin and be held in place with a mechanical arm or hand-held. Since the therapy probe has a fixed focus, multiple therapy probes are included to target stones over a range of skin-to-stone distances.

The Break Wave device is a portable lithotripter the size of a diagnostic ultrasound system, and the user operates the device similarly to operating a diagnostic ultrasound system. The user applies ultrasound coupling gel to the therapy/imaging probes, places the probe assembly against the patient's skin, and scans the abdomen to locate the stone(s) using standard ultrasound imaging techniques. Once the stone is identified and positioned within the target zone, the operator presses and releases the foot pedal to activate therapy. The operator monitors the fragmentation of the stone in real-time via the coaxial aligned imaging probe. The operator has the option to stop the therapy at any time by pressing and releasing the foot pedal a second time. Treatment may continue with up to 30 minutes of therapy. The device can be used without the need for patient sedation.

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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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