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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 Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.

The devices are for use in professional Healthcare Facility Environment.

The device consists of a Single-use Flexible Cystoscope and a Digital Video Monitor for endoscopic image processing and displaying. They are used in conjunction with other accessories for the endoscopy and treatment of adult bladder.

The provided document, a 510(k) summary for the Hunan Vathin Medical Instrument Co. Ltd's Single-use Flexible Cystoscope and Digital Video Monitor, describes non-clinical performance testing for device acceptance and claims substantial equivalence to a predicate device. However, it does not contain information related to a study proving the device meets acceptance criteria through clinical performance metrics, multi-reader multi-case (MRMC) studies, or AI-assisted diagnostic improvements. The document focuses on bench testing, biocompatibility, electrical safety, sterilization, software validation, and cybersecurity.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including specifics on sample size, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or how training ground truth was established. This information is typically found in clinical validation studies, which are not detailed in this 510(k) summary.

The document primarily addresses the safety and fundamental performance of the device itself (e.g., optical properties, mechanical bending, material biocompatibility) rather than its diagnostic accuracy or impact on human reader performance, especially in relation to AI assistance.

Despite the lack of information to fully address your request, here's what can be extracted from the document regarding acceptance criteria for non-clinical performance:

1. A table of acceptance criteria and the reported device performance (based on non-clinical tests):

2. Sample size used for the test set and the data provenance: Not applicable/Not provided. The document describes bench testing on the device itself, not a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth for clinical diagnostic performance is not discussed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.

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/Not provided. This device is a flexible cystoscope, not an AI-powered diagnostic system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/Not provided. This device is an endoscope, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided. The "ground truth" for the non-clinical tests would be the established engineering and safety standards (e.g., ISO, IEC, ASTM) and the device's design specifications.

8. The sample size for the training set: Not applicable/Not provided. This is a hardware device, not an AI algorithm requiring a training set of data.

9. How the ground truth for the training set was established: Not applicable/Not provided.

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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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