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The single use andorate® Suction Valve is used to control the suction of an endoscope during GL endoscopic procedures.

The single use andorate® Air/Water Valve is used to control the air / water function of an endoscope during GI endoscopic procedures.

The subject devices are intended for single-use and are supplied sterile. The suction valve is designed to be attached to the suction port of the endoscope and the air/water valve is designed to be attached to the air/water port of the endoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the endoscope image, while the activation of the air/water valve allows the user to control air and water flow to assist in cleansing the lens during procedures.

This is a 510(k) premarket notification for andorate Suction Valve and andorate Air/Water Valve. The document states that performance tests were conducted to support substantial equivalence to a predicate device. However, the document does not provide specific acceptance criteria or detailed results of these tests in a quantitative manner that would allow for a table of acceptance criteria and reported performance. It only lists the types of tests performed.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is the information that can be extracted:

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

The provided document lists the types of performance tests conducted but does not specify the numerical acceptance criteria or the quantitative results of these 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 size for the test set or the data provenance. It only states that "bench testing was performed."

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 study involved bench testing (performance tests) of a medical device (suction and air/water valves), not data analysis requiring expert interpretation or ground truth establishment.

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

This information is not applicable for bench testing of a 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 the study involved bench testing of a physical medical device, not an AI-assisted diagnostic tool.

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

This information is not applicable for bench testing of a physical medical device.

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

For bench testing, the "ground truth" would be the engineering specifications and performance standards that the device is designed to meet. The document states that the performance data "demonstrated that the subject devices met established specifications."

8. The sample size for the training set

This information is not applicable as the study involved bench testing of a physical medical device, not an AI model that requires a training set.

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

This information is not applicable as there was no training set for an AI model. For the device itself, the "ground truth" or acceptable performance standards for the bench tests would have been established based on engineering specifications and relevant regulatory guidelines.

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