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The submitted ureteroscopes and uretero-renoscopes are used to examine the ureter and kidney. Various diagnostic and therapeutic procedures can be performed by using additional accessories, for example disintegration of ureteroliths and kidney stones, biopsy for tumor diagnosis or removal of foreign bodies.

The submitted devices are thin endoscopes with fiber image bundle and an oval channel for irrigation and for use of one or two instruments simultaneously.

The devices have a direct view, an oblique or an offset eyepiece.

A single or double instrument port is needed for the insertion of the auxiliary instruments. For lithoclast application an additional guide is used.

The longer endoscopes are called uretero-renoscopes and are used for procedures in ureter and kidney. The shorter ones are called ureteroscopes and are used for procedures in ureter (and for procedures in kidney, if the urinary tract is short enough).

The provided text describes a 510(k) summary for "Compact Operating Fiber Uretero-Renoscopes and Ureteroscopes" by Richard Wolf Medical Instruments Corporation.

Based on the provided document, the following observations can be made regarding acceptance criteria and device studies:

1. A table of acceptance criteria and the reported device performance:

The document mentions two performance tests, but does not explicitly state numerical acceptance criteria for them. General statements about performance are made.

2. Sample size used for the test set and the data provenance:

• Sample size for test set: Not specified. The document states "tests performed by Richard Wolf" for the steam sterilization, implying internal testing, but no number of units tested is given.
• Data provenance: The performance data described (mechanical load test, steam sterilization) appears to be from internal laboratory testing conducted by Richard Wolf Medical Instruments Corporation. The country of origin of the data is implicitly the USA, where the company is located. The tests are retrospective in the sense that they were conducted on the device models being submitted, not as part of a prospective clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The performance tests described (mechanical bending, optical quality after sterilization) are objective engineering tests, not subject to expert interpretation for ground truth.

4. Adjudication method for the test set:

This information is not applicable/provided. The performance tests are objective engineering assessments; adjudication by experts would not typically be relevant for these types of tests.

5. 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:

No MRMC comparative effectiveness study was done. This is a hardware medical device (endoscope), not an AI-powered diagnostic tool. The document explicitly states: "No clinical tests performed."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a hardware medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the reported performance tests seems to be based on:

• Mechanical integrity: The device not fracturing under normal use (for the bending test).
• Optical quality preservation: The optical quality not being influenced by steam sterilization.
  These are objective, direct physical measurements or observations.

8. The sample size for the training set:

Not applicable. This is a hardware medical device; there is no "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

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