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For endoscopic access and examination of the lower urinary tract including the bladder and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The device system described in this 510(k) consists of a flexible, fiberoptic cystoscope and sterile, single use protective sheath.

The provided text is a 510(k) summary for a medical device, the Vision-Sciences Flexible Cystoscope with EndoSheath® System. It describes the device, its indications for use, and a general statement about safety and performance. However, it does not contain the detailed study information needed to fully answer your request.

The 510(k) summary states that "Performance testing included sheath burst/leak testing, sheath tensile/elongation testing, sheathed scope articulation testing, sheathed scope image quality evaluation and scope cycle testing." This indicates that tests were performed, but the specific acceptance criteria, reported performance, sample sizes, ground truth establishment, or any details about human reader studies are not present in this document.

Therefore, I can only provide a partial answer based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document only lists the types of performance tests conducted, not their specific criteria or results.

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

Not available in the provided text.

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

Not available in the provided text.

4. Adjudication method for the test set

Not available in the provided text.

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

Not applicable. This device is a flexible cystoscope with a sheath, not an AI-powered diagnostic tool. The concept of "human readers improve with AI" does not apply to this type of medical device based on the provided information.

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

Not applicable. This device is a flexible cystoscope with a sheath, not an AI algorithm.

7. The type of ground truth used

Not available in the provided text. The performance tests mentioned (burst/leak, tensile/elongation, articulation, image quality, cycle testing) suggest engineering and functional performance parameters, which would likely have internal performance specifications as their "ground truth" rather than clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

Not applicable. This device is a flexible cystoscope with a sheath, not a machine learning model that requires a training set.

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

Not applicable.

Summary of what can be inferred from the provided text:

• Acceptance Criteria & Performance: The document states that performance testing was performed for:
  • Sheath burst/leak
  • Sheath tensile/elongation
  • Sheathed scope articulation
  • Sheathed scope image quality
  • Scope cycle testing
  • However, the specific numeric acceptance criteria and the actual reported performance values are not disclosed in this 510(k) summary.
• Study Type: The studies mentioned are engineering and functional performance tests of the device components, not clinical studies involving patient data or expert interpretation in the way AI performance studies are conducted.
• Conclusion from the 510(k) Summary: "Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the proposed VSI Flexible Fiberoptic Cystoscope with EndoSheath® System has been shown to be safe and effective for its intended use." This indicates that the device did meet whatever acceptance criteria were established for the performance tests conducted, as this is a prerequisite for receiving 510(k) clearance.

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