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The Ureterorenoscope System consists of a sterile single-use disposable Flexible Ureteroscope to be introduced within the urinary tract and video processor for clinical image processing. The device is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.

The Ureterorenoscope System consists of a sterile single-use disposable Flexible Ureteroscope to be introduced within the urinary tract and endoscope operating system for clinical image processing.

The provided text describes a 510(k) premarket notification for a Ureterorenoscope System. It outlines the device, its indications for use, comparison with predicate devices, and performance data provided in support of substantial equivalence. However, it does not contain information related to acceptance criteria, specific study designs, or performance metrics in a way that would allow for a detailed response to all aspects of your request.

Specifically, the document discusses "performance data" in general terms, such as "Biocompatibility testing," "Sterilization and shelf life testing," "Electrical safety and electromagnetic compatibility (EMC)," "Software Verification and Validation Testing," "Optical performance testing," and "Mechanical performance testing." It states that "All evaluation acceptance criteria were met" for biocompatibility and that the system "complies with" various ISO and IEC standards for other tests, but it does not provide:

• A table of specific acceptance criteria and reported device performance values. It only gives broad statements of compliance.
• Sample sizes used for test sets or data provenance for these performance tests (e.g., country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or any effect size. This type of study is more common for AI/diagnostic support systems, which this device is not described as.
• If a standalone (algorithm only) performance study was done. This is not an AI algorithm; it's a medical device.
• The type of ground truth used (e.g., pathology, outcomes data). While it mentions testing, it does not specify how "ground truth" was established for, say, optical or mechanical performance beyond compliance with standards.
• Sample size for the training set. This is not an AI device that would typically have a "training set" in the machine learning sense.
• How ground truth for the training set was established.

Therefore, based on the provided text, I can only extract the following limited information regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not specified in the provided text. The document states that various performance tests were conducted (e.g., Biocompatibility, Electrical Safety, Optical Performance, Mechanical Performance) but does not provide details on the sample sizes used for these tests or the provenance of any data (e.g., country of origin, retrospective/prospective). These are typically bench and lab tests, not clinical studies with patient data in the sense of AI/diagnostic algorithms.

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

• Not applicable/Not specified in the provided text. The "ground truth" for these types of engineering and biocompatibility tests is typically established by fulfilling predefined engineering specifications and international standards, rather than expert human interpretation of data in the way medical images are interpreted. No information about experts or their qualifications is provided.

4. Adjudication method for the test set:

• Not applicable/Not specified in the provided text. Adjudication methods like 2+1 or 3+1 are relevant for interpreting medical data (e.g., images) where human judgment might vary. For the performance tests described (e.g., electrical safety, mechanical, biocompatibility), the assessment is typically against objective, quantifiable standards, not subjective expert adjudication.

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, an MRMC comparative effectiveness study was not done. The Ureterorenoscope System is described as a medical device (endoscope) for visual examination and procedures, not an AI or diagnostic assistance tool that would typically involve human readers interpreting output or benefiting from AI assistance.

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

• Not applicable. This device is a physical ureterorenoscope system, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for the various performance tests (e.g., Biocompatibility, Electrical Safety, Optical Performance, Mechanical Performance) was compliance with established international and national standards (e.g., ISO 10993-1, ISO 11135, IEC 60601 series, ISO 8600 series) and predefined engineering specifications. This is not medical ground truth like pathology or outcomes data.

8. The sample size for the training set:

• Not applicable. The Ureterorenoscope System is a hardware medical device and does not involve AI or machine learning that would require a "training set."

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

• Not applicable. As the device does not involve AI/ML, there is no training set or corresponding ground truth establishment process.

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