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ShockPulse-SE Lithotripsy System is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.

The ShockPulse-SE Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse-SE Lithotripsy System consists of generator, probes, transducer, cleaning stylet, wrench, power cord and nosecone. Footswitch is optional.

The provided document is a 510(k) premarket notification for a medical device called the ShockPulse-SE Lithotripsy System. It outlines the regulatory review process and confirms the device's substantial equivalence to a predicate device.

However, this document does not contain the detailed information necessary to answer your specific questions related to acceptance criteria, study design for device performance (especially for AI/ML models), sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

This K171024 submission focuses on demonstrating substantial equivalence based on the device's technological characteristics, intended use, and general performance testing (electrical safety, EMC/EMI, biocompatibility, etc.). It describes a physical medical device (a lithotripsy system for kidney stones), not an AI/ML-driven diagnostic or therapeutic system.

Therefore, I cannot provide the requested information for the following reasons:

• No AI/ML Component: The ShockPulse-SE Lithotripsy System is an electrohydraulic lithotriptor. There is no mention of any AI or machine learning component in its design or function. Your questions are specifically tailored to the evaluation of AI/ML devices.
• Performance Data Limitations: The document lists general performance tests (e.g., "Mass removal rate," "Drill rate," "Displacement," "Frequency") and states "Pass" for all of them. However, it does not provide:
  • Specific acceptance criteria values (e.g., "Mass removal rate must be > X mg/s").
  • The detailed methodology of these performance tests.
  • Any information on "test sets," "training sets," "ground truth," "expert consensus," "adjudication," or "human reader studies" as these are not relevant to the type of device being described.

In summary, the provided text does not contain the information requested in your prompt because it describes a traditional medical device, not an AI/ML system. If you have a document describing an AI/ML medical device, I would be happy to analyze it for the requested details.

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