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An endoscopic intracorporeal pneumatic lithotripter probe for use in fragmenting urinary calculi, including renal, ureteral and bladder stones through rigid, semi-rigid and flexible endoscopes.

Endoscopic Intracorporeal Pneumatic Lithotripter Probe

The provided text is a 510(k) Premarket Notification for a Lithotripsy Probe from 1997. It describes the device, its intended use, and claims substantial equivalence to existing products. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document primarily focuses on:

• Administrative details: Sponsor information, contact person, submission date, common/usual names, device classification, and substantial equivalence claim.
• FDA Communication: The FDA letter confirms the review of the 510(k) notification and a finding of "substantial equivalence" to a legally marketed predicate device, allowing the manufacturer to market the device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text, as this information is absent. The sections of your request (1-9) cannot be answered.

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