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A collection of sterile device intended to be fitted to multiple endoscope working channels/ports to enable anoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes a suction valve, an air/water valve, and a biopsy valve. This is a single-use device.

Wilson's Disposable Endoscope Valves Set A collects three types of valve products into one package unit. Disposable Endoscope Valves Set A can make it convenient for the replacement of Air/Water Valves, Suction Valves, Biopsy Valve during an endoscopic procedure. And these three types' valves can realize their intended uses respectively.

The provided text describes a 510(k) premarket notification for a medical device: Disposable Endoscope Valves Set A. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of studies typically associated with AI/ML devices (e.g., diagnostic accuracy, reader studies).

Therefore, the information required to answer your specific questions about "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size," "ground truth," "MRMC studies," etc., is not present in the provided document.

The document states:

• "The Disposable Endoscope Valves Set A of Wilson has taken the biocompatibility, sterility and performance testing into concern in accordance to Food and Drug Administration related guidance and recognized international standards. Test data and report information are included in this submission."

This indicates that some performance testing was done, but the details of these tests (specific acceptance criteria, sample sizes, methodology, and results) are not included in the publicly available summary (510(k) Sumary/Clearance Letter). These details would typically be found in the full 510(k) submission, which is not publicly released in its entirety.

Based on the available text, here's what can be inferred and what remains unknown regarding performance demonstration:

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

• Acceptance Criteria: Not explicitly stated in the provided text. The device is for "endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials." Implied criteria would relate to these functions (e.g., proper sealing, fluid/gas control, ease of use, compatibility).
• Reported Performance: No specific numerical performance metrics are provided. The general statement is that "Test data and report information are included in this submission" and that the device is "substantially equivalent to predicate devices with regard to safety and effectiveness."

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

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective). These would likely be bench tests or in-vitro tests, not clinical data sets in the way AI/ML models are evaluated.

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

• Not applicable in the context of this device. "Ground truth" in the sense of expert consensus labels for diagnostic images is not relevant here. Performance testing for this type of mechanical device would involve engineering specifications, material compatibility, and functional tests (e.g., seals holding pressure, flow rates).

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

• Not applicable. This method is used for establishing ground truth in image interpretation studies, not for the functional testing of a mechanical device.

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. This is a mechanical device, not an AI diagnostic tool. MRMC studies are not relevant.

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

• Not applicable. This device does not involve an algorithm.

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

• For this type of device, "ground truth" refers to established engineering standards, physical properties of materials, and functional performance benchmarks (e.g., a valve successfully prevents retrograde flow under specified pressures, or a seal maintains integrity for a certain duration). It's not data derived from human interpretation or patient outcomes in the sense of diagnostic accuracy.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

Summary of what the document DOES tell us about the device and its clearance process:

• Device Name: Disposable Endoscope Valves Set A
• Intended Use: To be fitted to endoscope working channels/ports to control function and prevent retrograde flow of fluids, gases, and other materials. Includes suction, air/water, and biopsy valves. Single-use.
• Regulatory Class: Class II, Product Code ODC, under 21 CFR 876.1500 (Endoscope and accessories).
• Predicate Devices: OLYMPUS DISPOSABLE SUCTION VALVE (K920025), OLYMPUS DISPOSABLE BIOPSY VALVE (K911412), EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I(MH-438) (K001241).
• Demonstration of Safety and Effectiveness: Through "biocompatibility, sterility and performance testing in accordance to Food and Drug Administration related guidance and recognized international standards." It applies "EO sterilization method, which is also same as that of SE product."
• Conclusion: The device is "substantially equivalent to predicate devices with regard to safety and effectiveness."

This document highlights the differences in regulatory review processes for different types of medical devices. For a mechanical device like an endoscope valve, the focus is on physical and material properties, sterilization, and functional performance against established engineering standards and comparison to similar predicate devices, rather than the complex clinical study designs seen for AI/ML or diagnostic imaging devices.

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