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The Disposable Endoscope Valves System includes an air/water valve, a suction valve, a biopsy valve, a water connector, AW channel cleaning Adapter and suction cleaning adapter

Disposable Biopsy Valve, it 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 Air/Water Valve, it is intended to be fitted to an endoscope Air/water channel to enable the operator to control inflow of medical gases and water.

Disposable Suction Valve, it is intended to be fitted to an endoscope suction channel to enable the operator to control suction.

Water Jet Connector, it is intended to prevent liquid backflow when providing sterile water to the endoscope during endoscopic surgery.

Disposable AW Channel Cleaning Adapter, it is attached to the air/water cylinder of the endoscope, used for the air water channel pre-cleaning after the procedure.

Disposable Suction Cleaning Adapter also as one of accessories of the pre-cleaning endoscopic irrigation. The one end can be connected to the biopsy channel. the other end be connected to the water container. It is used to aspirate reprocessing fluids through the instrument channel port of the endoscope.

The Endoscope Valves Systemare used to fit to multiple endoscope working channels/ports to enable anendoscope operator control the function of the working channels/ports and prevent retrograde flow of the fluids, gases, and other materials. It includes an air/water valve, a suction valve, a biopsy valve, a water connector, AW channel cleaning Adapterand suction cleaning adapter.All valvesare single-use device and packed individually in a sealed package or different types of valves products is packed into one package units. The valves are manufactured for use with OLYMPUS Endoscope Series, FUJIFILM Endoscope 700 Series, and Pentax 90 series endoscope.Some valvemay besold as both sterileand non-sterile.

The provided text is a 510(k) Summary for a medical device (Disposable Endoscope Valves System) seeking FDA clearance based on substantial equivalence to a predicate device. This type of submission generally focuses on non-clinical testing to demonstrate performance, safety, and equivalence, rather than a clinical study in the traditional sense of evaluating efficacy in human subjects.

Here's a breakdown of the requested information based on the provided document:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly list "acceptance criteria" with specific numerical targets in a table format for the performance tests. Instead, it states that "All evaluation acceptance criteria were met" for biocompatibility and that performance testing was conducted to verify "all design specifications" and "substantial equivalence to the predicate device." The reported device performance is summarized as meeting these unspecified criteria.

Here's how we can infer the "acceptance criteria" and "reported performance" based on the described tests:

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 sample sizes used for any of the performance tests (e.g., water flow, suction flow, side-by-side or compatibility tests). The data provenance is implied to be from the manufacturer's internal testing. The country of origin of the manufacturer is China. The nature of the tests (performance, biocompatibility) implies they are prospective tests performed on new 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 type of information is usually associated with clinical studies involving human observers or expert reviews of complex data (e.g., medical images). For a device like an endoscope valve system, "ground truth" is established through engineering and laboratory testing protocols, often by qualified technicians and engineers following established standards. The document does not mention the use of experts in the sense of medical specialists establishing ground truth for the performance tests.

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

Not applicable. Adjudication methods are typically used in clinical studies where multiple human readers assess data and discrepancies need to be resolved. The non-clinical tests described (biocompatibility, water/suction flow, side-by-side, compatibility, sterilization, shelf-life) involve objective measurements and established protocols rather than subjective interpretation requiring adjudication.

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. The submitted device is a physical medical device (endoscope valves system), not an AI-powered diagnostic or assistive tool. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.

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

Not applicable. The submitted device is a physical medical device, not a standalone algorithm.

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

For the non-clinical tests described, the "ground truth" is based on:

• Biocompatibility: Established ISO standards (ISO 10993-1:2009) and laboratory test results demonstrating the absence of toxic or reactive responses.
• Performance (Water flow, Suction flow): Design specifications and performance characteristics of the predicate device, against which the proposed device was compared ("Side by side test").
• Compatibility: Successful functional operation with the specified endoscope models.
• Sterilization: Adherence to the validated sterilization parameters per ISO 11135.
• Shelf-life: Results from accelerated aging tests projecting a 3-year product life.

8. The sample size for the training set

Not applicable. As a physical medical device, there is no "training set" in the context of an AI algorithm. The device's design and manufacturing processes are refined through engineering development, not machine learning training.

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

Not applicable, as there is no training set for this type of device.

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The Disposable Endoscope Valves System includes an air/water valve, a biopsy valve, a biopsy valve and a water connector.

Disposable Biopsy Valve, it 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 biomaterial during an endoscopic procedure.

Disposable Air/Water Valve, it is intended to be fitted to an endoscope Air/water channel to enable the operator to control inflow of medical gases and water.

Disposable Suction Valve, it is intended to be fitted to an endoscope suction channel to enable the operator to control suction.

Water Jet Connector, it is intended to prevent liquid backflow when providing sterile water to the endoscope during endoscopic surgery.

The Endoscope Valves System are used to fit to multiple endoscopes working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of the fluids, gases, and other materials.

It includes an air/water valve, a suction valve, a biopsy valve and a water connector. All valves are single-use device and packed individually in a sealed package or different types of valves products is packed into one package units. The valves are manufactured for use with OLYMPUS Endoscope Series, FUJIFILM Endoscope 700 Series, and Pentax 90 series endoscope. Some valve mav be sold as both sterile and non-sterile.

The provided text is a 510(k) summary for a medical device (Disposable Endoscope Valves System) submitted to the FDA. It details the device, its intended use, comparison to predicate devices, and non-clinical testing performed to demonstrate substantial equivalence.

However, this document does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device. The device described is a physical medical device (valves for endoscopes), not an AI/ML algorithm.

Therefore, many of the requested points related to AI/ML device studies (such as sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable to this submission.

The document discusses the following types of testing for this physical device:

• Biocompatibility testing: Performed in accordance with ISO 10993-1:2009 for "Surface – Mucosal Membrane" with limited contact duration. Tests included Cytotoxicity, Irritation, and Intracutaneous Reactivity. All acceptance criteria were met.
• Performance testing: Specific tests for each valve type:
  • Biopsy Valves: Sealing performance test, Strength of assemble.
  • Air/Water Valves: Air leakage test, Water flow test.
  • Suction Valves: Suction flow test.
  • Water Jet Connectors: Positive pressure performance test, Backpressure performance test, Backflow Prevention Test.
  • Compatibility testing: To confirm compatibility with commercial endoscopes (Pentax, Olympus, Fujifilm Gastrointestinal Endoscopes).
• Sterilization and Shelf-life testing: Sterilization validated to ISO11135, and a 3-year shelf-life determined by accelerated aging.

The document explicitly states: "No clinical study is included in this submission." This further confirms that the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML algorithm's performance is not present in this document.

In summary, as the provided document pertains to a physical medical device (endoscope valves) and not an AI/ML medical device, the specific information requested about AI/ML acceptance criteria and performance studies is not available.

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