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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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Wilson disposable injection needle has been designed to be used with an endoscope to perform following therapy:

1. Endoscopic sclerotherapy within the esophagus, stomach, duodenum, small intestine, large intestine.
2. Endoscopic hemostasis within the esophagus, stomach, duodenum, small intestine, large intestine.
3. Endoscopic submucosal injection within esophagus, stomach, duodenum, small intestine, large intestine.

The subjected Disposable Injection Needle is operated together with an endoscope to conduct an endoscopic injection for the treatment of esophageal and gastric varices and submucosal injection in the digestive tract, such as esophagus, stomach, duodenum, small intestine, large intestine.

The subjected device is primarily constituted of handle, tube and needle. The models include PN series, PM series and PM(H) series.

The provided document is a 510(k) premarket notification for a medical device: "Disposable Injection Needle" (PN series, PM series, PM (H) series) by Wilson Instruments (Shanghai) Company Limited. This type of document is a regulatory submission for medical devices, primarily demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria, as one might find in a clinical trial report or a performance study for AI/software as a medical device (SaMD).

Here's an analysis based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of quantitative acceptance criteria for performance, nor does it present specific device performance results in a measurable, quantifiable way against such criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device through:

• Similar intended use.
• Similar technological characteristics (materials, design, sterilization method).
• Compliance with biocompatibility, sterility, and performance testing in accordance with FDA guidance and international standards.

For medical devices like injection needles, "performance" is often assessed through bench testing for things like needle sharpness, force of injection, material integrity, sterilization effectiveness, and biocompatibility, rather than diagnostic accuracy metrics. The document states that "Test data and report information included in this submission demonstrate that the subjected device is substantially equivalent to the predicate device," but these specific test results are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in the context of data for an AI/SaMD product. It refers to "test data and report information" for biocompatibility, sterility, and performance, which would typically involve physical samples of the device undergoing laboratory testing. The sample sizes for these types of tests are not disclosed in this summary. Data provenance (country of origin, retrospective/prospective) is not applicable in the context of this device and type of submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable to a disposable injection needle. Ground truth, expert consensus, or clinical outcome data are typically relevant for diagnostic or AI devices where there's an interpretation or prediction being made that can be compared against a 'truth'. For an injection needle, the "ground truth" related to its function is derived from engineering specifications and objective physical/chemical tests.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in expert interpretations in diagnostic studies.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done for this device. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers) to assess the impact of AI assistance on human performance. The Disposable Injection Needle is a physical therapeutic/interventional device.

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

No, a standalone performance study (algorithm only) was not done. This is also specific to AI/SaMD products.

7. The Type of Ground Truth Used:

As noted, the concept of "ground truth" in the diagnostic/AI sense is not applicable. For this physical device, the "truth" is established by:

• Engineering specifications: Meeting defined physical dimensions, material properties, and functional performance (e.g., needle sharpness, strength).
• Biocompatibility testing: Adhering to standards (e.g., ISO 10993) to ensure no adverse biological reactions.
• Sterility testing: Confirming the absence of viable microorganisms per established standards.
• Material safety data: Ensuring components are safe for their intended use.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" for a physical medical device like an injection needle. Training sets are used in machine learning for AI algorithms.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set.

Summary of Acceptance Criteria and Evidence from the Document:

The document states that the device is "substantially equivalent" to the predicate device (Olympus Injector NM-4-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 cleared via K011484). The "acceptance criteria" can be inferred as meeting the same performance, safety, and effectiveness profiles as the predicate device.

Inferred Acceptance Criteria (not explicitly quantitative in the document):

In conclusion, this 510(k) summary focuses on demonstrating substantial equivalence of a physical medical device (Disposable Injection Needle) to a legally marketed predicate. It does not contain the specific detail about acceptance criteria, study design, and performance metrics typically seen for AI/SaMD or clinical trial reports. The "study" proving the device met the criteria would consist of laboratory tests for biocompatibility, sterility, and various physical performance tests, the details of which are not included in this summary but would have been part of the full 510(k) submission.

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