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XZING-W200B Disposable GI Endoscope: The disposable GI endoscope (XZING-W200B) is designed to be used with XZING-S2 Camera System, monitor and other peripheral device for endoscopic observation, diagnosis and treatment of the adult upper gastrointestinal tract. It is a single use disposable device and cannot be reused.

XZING-C200B Disposable Colonoscope: The Disposable Colonoscope (XZING-C200B) is designed to be used with XZING-S2 Camera System, monitor and other peripheral device for electronic colonoscope observation, diagnosis and treatment of the adult lower digestive tract (including the anus, rectum, colon and ileocecal segment). It is a single use disposable device and cannot be reused.

XZING-S2 Camera System: The Camera System is designed to be used with the XZING endoscopes, monitor and other peripheral device for endoscopic observation, diagnosis and treatment.

The proposed system, Endofresh Digestive Endoscopy System, includes a disposable GI endoscope, a disposable colonoscope and a camera system (refer to Table 1) They are used together with the monitor and other peripheral device for electronic endoscopic observation, diagnosis and treatment of adult upper gas trointestinal tract or adult lower digestive tract.

The disposable GI endoscope and disposable colonoscope are the hand-held, direct-viewing flexible endoscope used for endoscopy and endoscopic surgery within the upper and lower gastrointestinal tract. There are two LED lamps to provide illumination for endoscopic diagnosis, treatment and video observation. The disposable OI endoscope and disposable colonoscope are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

The camera system is a video processing system which is designed to be used with the proposed endoscopes, monitor and other peripheral device. The camera system only has one imaging mode, white light imaging mode. Apat from the image processing functions, it also provides power supply for the endoscopes.

The display is not included in the Endofresh Digestive Endoscopy System. The display should have following color performance and color space to ensure the color performance of the whole system.

The provided text is a 510(k) Summary for the Endofresh Digestive Endoscopy System (K192704). It primarily focuses on demonstrating substantial equivalence to a predicate device (K100584, EVIS EXERA II 180 System) through non-clinical testing and comparison of specifications.

Unfortunately, the document does not contain information about acceptance criteria for specific performance metrics, nor does it detail a study proving the device meets particular acceptance criteria for diagnostic accuracy or effectiveness in a clinical setting.

Instead, the document highlights that no clinical study was included in the submission (Section 9. Clinical Test Conclusion). The determination of substantial equivalence is based on non-clinical tests (electrical safety, EMC, product performance against standards like ISO 8600-1, biocompatibility, etc.) and a comparison of technical specifications between the proposed device and the predicate device.

Therefore, I cannot provide the requested table of acceptance criteria and reported device performance or information regarding sample sizes, ground truth establishment, expert adjudication, or MRMC studies for diagnostic performance, as these are not present in the provided text.

However, I can extract the information that is available regarding non-clinical testing and the comparison with the predicate device:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not present explicit acceptance criteria for diagnostic performance or reported clinical performance data. It focuses on adherence to recognized standards and comparison of technical specifications. The "acceptance criteria" can be inferred from conformity to these standards and equivalence to the predicate device.

2. Sample size used for the test set and the data provenance

• The document explicitly states: "No clinical study is included in this submission."
• Therefore, there is no test set from a clinical study mentioned.
• The non-clinical tests would have involved samples of the device and its components, but specific sample sizes for these engineering tests are not detailed in this summary.
• Data provenance is not applicable as no clinical data is presented.

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

• Not applicable as no clinical study or test set for diagnostic performance is described.

4. Adjudication method for the test set

• Not applicable as no clinical study or test set for diagnostic performance is described.

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. The device itself is an endoscopy system, not an AI-assisted diagnostic tool. No AI component is mentioned.

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

• Not applicable. This is a medical device (endoscopy system) without a standalone AI algorithm component.

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

• Not applicable as no clinical study or test set for diagnostic performance is described. The "ground truth" for the non-clinical tests would be the established scientific/engineering standards and specifications.

8. The sample size for the training set

• Not applicable as no AI/machine learning component is described for which a training set would be required.

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

• Not applicable as no AI/machine learning component is described.

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