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

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

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The provided document is a 510(k) clearance letter from the FDA for the "Bio Guard Air/Water & Suction Valves." This document primarily focuses on the regulatory clearance for a physical medical device (valves for endoscopes) and confirms its substantial equivalence to predicate devices. It does not contain information about the performance of an AI/ML powered medical device, nor does it describe an acceptance criteria study for such a device.

Therefore, I cannot extract the requested information using this document. It does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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