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The Single-Use Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder.

The Single-use Flexible Cystoscope can be connected to the compatible Vathin Display Units and other accessories for the endoscopy and treatment of adult bladder.

This document describes the validation of a Single-Use Flexible Cystoscope (K221580), comparing it to a predicate device, the Ambu Ascope 4 Cysto (K193095).

Based on the provided text, there is no detailed study described that proves the device meets specific acceptance criteria based on clinical outcomes or performance metrics suitable for a table of reported device performance. The document primarily focuses on non-clinical testing to demonstrate substantial equivalence to the predicate device.

Here's an analysis of the provided information relative to your request:

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

• Acceptance Criteria: The document lists numerous performance tests conducted. For each of these, acceptance criteria would have been established internally by the manufacturer, and the device's performance would have been compared against these. However, these specific acceptance criteria and the quantified reported device performance (e.g., 'Bending angle: device achieved X degrees vs. acceptance criteria Y degrees') are NOT provided in this FDA 510(k) summary. The document only states that "All evaluation acceptance criteria were met" for biocompatibility and that the system "complies" with electrical safety and EMC standards, and that various performance tests were "conducted."

Therefore, a table cannot be fully constructed with the information given. The types of performance tests conducted are:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document does not specify sample sizes for the non-clinical tests in terms of the number of devices tested for each characteristic. These tests are typically performed on a representative sample of devices.
• Data Provenance: The tests were conducted by the manufacturer, Hunan Vathin Medical Instrument Co., Ltd., which is based in China. The data is from non-clinical bench testing, not patient data. Therefore, it is neither retrospective nor prospective in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This document describes non-clinical performance and safety testing (e.g., measuring bending angle, image resolution, electrical safety). There is no "ground truth" derived from expert clinical assessment for this type of testing. Ground truth, in this context, would be the precisely measured physical or electrical properties per engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. As this is non-clinical bench testing, there are no "readers" or adjudication methods as would be found in clinical studies involving interpretation of images or patient data by multiple experts. The tests are based on objective measurements against engineering specifications.

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 study was done. This device is a flexible cystoscope, a medical instrument, not an AI-powered diagnostic algorithm. It is a tool used by human operators. The concept of "human readers improve with AI vs without AI assistance" does not apply to this submission.

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

• Not applicable. This is a medical instrument, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the non-clinical performance and safety tests, the "ground truth" is derived from established engineering standards, test methods, and predefined measurement tolerances described in relevant international standards (e.g., ISO, IEC). For example, a "bending angle" test measures the actual mechanical bending angle of the scope, which is then compared against a specified design tolerance. It's objective measurement against a technical specification, not clinical ground truth like pathology.

8. The sample size for the training set

• Not applicable. This is a hardware device, not an AI model that requires a training set.

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

• Not applicable. No training set is involved.

In summary: The provided 510(k) summary focuses on demonstrating the substantial equivalence of the Single-Use Flexible Cystoscope through comprehensive non-clinical bench testing and adherence to recognized standards for biocompatibility and electrical safety. It does not include clinical studies, expert consensus reviews, or AI performance evaluations. The specific acceptance criteria and the quantitative performance results for each non-clinical test are not detailed in this public FDA summary.

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