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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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The EHL probe is designed for use with Potent Medical Electrohydraulic Lithotripter (TCS-B3-II) for disintegration of concernments in the bile duct.

The SCDG -AS, SCDG -BS, and SCDG CS are sterile, single-use electrohydraulic lithotripsy (EHL) probes. These probes are designed to be used with the Electrohydraulic Lithotripter (TCS-B3-II) for the fragmentation of biliary calculi. The probes deliver low-energy electrical pulses through a dedicated connection to the generator, generating hydraulic shock waves in a saline medium to fragment stones in the biliary tract.

The provided text is a 510(k) summary for a medical device (EHL probe) seeking FDA clearance. It describes the device, its intended use, comparison to a predicate device, and performance data from bench testing. However, it does not contain information about a clinical study involving human subjects or AI algorithms, which is typically where the concepts of "acceptance criteria," "human readers improve with AI vs without AI assistance," "standalone performance," "training set," and "ground truth establishment" would be relevant.

The document primarily focuses on bench testing to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission relies on the device meeting certain engineering specifications and performance characteristics, rather than a clinical trial with specific diagnostic accuracy metrics.

Therefore, many of the requested details about acceptance criteria and study design are not applicable (N/A) based on the provided text.

Here's a breakdown of the information that can be extracted from the document, along with an explanation for the N/A sections:

Acceptance Criteria and Device Performance (Based on Bench Testing)

The document does not present a formal table of "acceptance criteria" and "reported device performance" in the way one would establish for, say, an AI-powered diagnostic device. Instead, it describes various bench tests conducted to ensure the device meets safety and performance standards comparable to the predicate device. The implicit acceptance criterion for each test is that the probe performs as expected and similarly to the predicate device, demonstrating substantial equivalence.

Study Details (Applicable to Clinical/AI Performance Studies)

As stated, this document describes a 510(k) submission based on bench testing for substantial equivalence, not a clinical study involving human performance or an AI algorithm. Therefore, the following information is not present or applicable:

1. Sample size used for the test set and the data provenance: N/A (No clinical test set described). The testing was bench-based.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No ground truth for a test set of clinical data was established).
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No test set of clinical data requiring adjudication).
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A (No MRMC study or AI component described).
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (No algorithm or standalone performance described).
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (Ground truth in a clinical sense is not applicable here; performance was demonstrated through engineering and material testing against established standards and predicate device performance).
7. The sample size for the training set: N/A (No training set for an AI algorithm described).
8. How the ground truth for the training set was established: N/A (No training set for an AI algorithm described).

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