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To Alleviate or correct simple snoring by maintaining an open airway during sleep and to prevent bruxing and grinding of teeth.

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The provided document is a 510(k) clearance letter from the FDA for "Dr. B's Mouthpiece, Model 32129-10002" with the trade name "Snore-Ezzer, LLC". This document states that the device has been found substantially equivalent to a legally marketed predicate device.

However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
2. Sample sized used for the test set and the data provenance: This information is not present in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the document.
4. Adjudication method for the test set: This information is not present in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: This information is not present in the document.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This information is not present in the document.
7. The type of ground truth used: This information is not present in the document.
8. The sample size for the training set: This information is not present in the document.
9. How the ground truth for the training set was established: This information is not present in the document.

The document is a regulatory clearance and details the FDA's decision based on the application, not the technical study results themselves. To find the information you're looking for, you would typically need to refer to the 510(k) Summary or the 510(k) Premarket Notification submission documents, which are separate from this clearance letter.

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To reduce or alleviate snoring by maintaining an open airway during sleep.

Not Found

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a device called "Snore-Ezzer." It confirms that the device is substantially equivalent to a pre-amendments device and can be marketed.

While it mentions the "Indication For Use" (to reduce or alleviate snoring by maintaining an open airway during sleep), it does not provide:

• A table of acceptance criteria and reported device performance.
• Details about the sample size, data provenance, number of experts, adjudication method, or ground truth for any test set.
• Information about MRMC studies, standalone algorithm performance, or training set details.

The letter is a regulatory approval document, not a scientific study report or a summary of validation testing. It indicates that the device has met the regulatory requirements for market clearance based on a determination of substantial equivalence, but it does not disclose the specific performance metrics or studies used to demonstrate that functional equivalence.

Ask a specific question about this device