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Disposable Valve Sets includes either one air/water and suction valve or one air/water, suction and biopsy valve.

Disposable Air/Water Valve: This device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases and water, whilst preventing backflow during a GI Endoscopic procedure.

Disposable Suction Valve: The device intended to be fitted to an endoscope suction channel to enable the operator to control suction whilst preventing inflow of air during a GI Endoscopic procedure.

Disposable Biopsy Valve: This device is intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of bio material during an endoscopic procedure.

Disposable Valve Sets includes either one air/water and suction valve or one air/water, suction and biopsy valve. So we divided into two models for these devices. One suction valve, air/water valve and biopsy valve means model B, one suction valve and air/water valve means model A. These devices are supplied sterile. These valves easily incorporate into infection prevention policies as a single use item, and these valves are suitable for Olympus 140/160/190/240/260 series endoscopes.

The document describes the acceptance criteria and study to demonstrate substantial equivalence for the Disposable Valve Sets (intended for use with endoscopes) by Zhejiang Chuangxiang Medical Technology Co., LTD. against the predicate device Endorate™ Valve Sets (K181509) by Smardata Suzhou Co., Ltd.

Here's the detailed breakdown as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance" in a quantitative manner (e.g., specific thresholds and measured values). Instead, it states that "In-vitro Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." and "The testing successfully demonstrated essential performance is achieved before and after the shelf life test."

The following tests were performed and implicitly form the basis of the acceptance criteria by ensuring the device meets required specifications:

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 the exact sample sizes used for each of the in-vitro performance tests. It generally states that "In-vitro Testing has been performed" on "components, subassemblies, and/or full devices."

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature. However, given that "Zhejiang Chuangxiang Medical Technology Co., LTD." is located in Hangzhou, Zhejiang, China, it is highly probable that the testing was conducted in China. These would be considered prospective laboratory tests using newly manufactured device samples.

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)

This device is a physical medical instrument (valve sets), not an AI algorithm or diagnostic tool that relies on expert interpretation of data or images to establish a "ground truth." Therefore, the concept of "number of experts used to establish the ground truth" is not applicable in this context. The "ground truth" for this device's performance is established by objective engineering and safety standards (e.g., flow rates, leak resistance, mechanical force, biocompatibility standards).

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in studies involving human interpretation (e.g., radiology reads), especially for AI clinical trials. The performance of these physical valves is assessed against predefined engineering and material standards through objective laboratory measurements.

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 is a medical device (endoscope valve sets), not an artificial intelligence-powered diagnostic or assistive tool. MRMC studies are used to evaluate AI's impact on human reader performance.

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

Not applicable. This is a physical medical device. The concept of "standalone algorithm performance" does not apply. The performance tests evaluate the device itself.

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

The "ground truth" for the performance tests of the Disposable Valve Sets is based on objective engineering and safety specifications and recognized international standards. This includes:

• Physical performance criteria: Such as vacuum leak rates, flow rates (water and air), depression force, and leak resistance (squeegee leak test). These are quantifiable measurements.
• Sterilization standards: Meeting criteria defined in ISO 10993-7 for EO residual and achieving a SAL of 10⁻⁶.
• Shelf-life standards: Compliance with ASTM F1980-16 for accelerated aging and ISO 11607-1/2 for packaging.
• Biocompatibility standards: Compliance with FDA Guidance and ISO 10993-1 for cytotoxicity, sensitization, and intracutaneous irritation.

There is no "expert consensus" or "pathology" involved in determining if a valve leaks or if it's biocompatible beyond interpreting the results of the objective tests against established thresholds.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The device design and manufacturing processes are validated through engineering principles and testing.

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

Not applicable, as there is no training set for a physical medical device.

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