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The Electrohydraulic Lithotriptor is intended to be used with Potent Medical disposable electrohydraulic lithotripsy (EHL) probes for disintegration of concernments in the bile duct.

The EHL is a compact, table-top medical device designed for the fragmentation of biliary calculi. It operates by generating high-voltage electric pulses, which are transmitted through a compatible disposable EHL probe (sold separately) that is inserted into the biliary tract via an endoscope. The device features two operational modes: single pulse and continuous pulse. These electric pulses create hydraulic shock waves in a saline medium, causing fragmentation of biliary stones into smaller pieces that can either be naturally passed or removed endoscopically.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that specifically proves the device meets such criteria.

The document is a 510(k) summary for an Electrohydraulic Lithotriptor (TCS-B3-II) and focuses on demonstrating substantial equivalence to a predicate device (EL27-Compact). It outlines various performance and safety tests conducted but does not provide specific acceptance criteria values or detailed study results in the format requested.

The "Performance Data" section mentions "Stone Fragmentation Test," "Shockwave Pressure Attenuation Test," "Acoustic Characterization Test," "Electrical Safety and Electromagnetic Compatibility (EMC) Testing," and "Software Verification and Validation." However, it only describes what these tests validated or complied with (e.g., "validated the system's ability to generate consistent high-voltage pulses," "tested for compliance with IEC 61846," "tested for compliance with IEC 60601-1"), rather than presenting quantitative acceptance criteria and the device's reported performance against them.

Therefore, I cannot populate the table or answer the specific questions regarding sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details for any specific acceptance criteria from this text.

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