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The BioGuard EUS Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.

The BioGuard EUS Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.

The BioGuard EUS Air/Water Valve and the BioGuard EUS Suction Valve are accessories to an echoendoscope. The EUS Air/Water valve allows the end user to control air or CO2 insufflation down the endoscope's accessory channel, control water used to wash the lens of the endoscope and insufflate a balloon at the distal end of the echoendoscope.

The EUS Suction valve allows the user to control suction through the echoendoscope's accessory channel and suction to the balloon at the distal end of the echoendoscope.

Both devices are single use devices, supplied sterile.

The provided text is a 510(k) summary for a medical device (BioGuard EUS Air/Water and Suction Valves). It describes the device's technical characteristics, intended use, and comparison with a predicate device to demonstrate substantial equivalence. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-based device.

The document discusses functional bench and simulated use testing for the physical valves to ensure they control air/CO2 and water supply/evacuation. This is standard for mechanical devices but is not related to the acceptance criteria or study methodologies typically used for AI/ML-driven medical devices (e.g., performance metrics like sensitivity, specificity, AUC).

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance: The document does not define such criteria or report AI/ML performance metrics.
2. Sample size for test set and data provenance: Not applicable as no AI/ML study is mentioned.
3. Number of experts used to establish ground truth and qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for training set: Not applicable.
9. How ground truth for training set was established: Not applicable.

The document's conclusion states that "The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device." This refers to mechanical and functional performance, not AI/ML performance.

In summary, the provided text describes the regulatory clearance process for mechanical medical valves and does not contain the information requested regarding AI/ML device acceptance criteria or performance studies.

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