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The END-200 Tubeset is intended to be used with the EVA15 insufflator, to supply CO2 to an endoscope during gastrointestinal endoscopic procedures.

The END-200 Tubeset is a dual lumen tube with clips that attach to the outside of an endoscope. It connects to a CO2 gas source and is used to insufflate the cavity during an endoscopic procedure, and to provide a line to monitor pressure. It is single use, disposable and provided non-sterile similar to the predicate. The ENDO-200 Tubeset is offered in Small and Medium sizes.

The document provided is a 510(k) summary for the END-200 Tubeset, a medical device. It does not describe a study involving an AI algorithm or its performance criteria, but rather focuses on demonstrating substantial equivalence to a predicate device. Therefore, most of the requested information about AI study design and performance criteria is not applicable to this document.

However, I can extract the non-clinical testing performed and the general acceptance of the device based on that testing.

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

Based on the provided document, specific numerical acceptance criteria are not explicitly stated. Instead, the document mentions that the device "met its performance acceptance criteria" after testing.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: This information is not specified in the document for any of the non-clinical or animal testing.
• Data Provenance: Not specified. The document only mentions "Bench Testing" and "Animal Testing."

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 information is not applicable as the document describes non-clinical and animal testing for a physical medical device, not an AI algorithm requiring expert ground truth for image interpretation or similar.

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

This information is not applicable as the document describes non-clinical and animal testing for a physical medical 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

This information is not applicable as no AI algorithm is mentioned or studied in the provided document.

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

This information is not applicable as no AI algorithm is mentioned or studied in the provided document.

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

For the non-clinical testing:

• Bench Testing: The ground truth would be established by the engineering specifications and measurement standards for pressure accuracy.
• Animal Testing: The ground truth would be based on direct observation of the device's function, attachment, maneuverability, and assessment of tissue for injury by qualified animal study personnel (e.g., veterinarians, pathologists).
• Biocompatibility Testing: The ground truth is laboratory testing results conforming to ISO 10993 standards.

8. The sample size for the training set

This information is not applicable as no AI algorithm is mentioned or studied in the provided document.

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

This information is not applicable as no AI algorithm is mentioned or studied in the provided document.

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