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The ClearMask Transparent Surgical Face Mask is intended for use in healthcare settings, such as in operating rooms, or in other medical procedures such as dental, isolation and veterinary procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device allows for full view of the face and facial expressions, particularly the nose and mouth areas.

The device is indicated for over-the-counter use. The device is disposable and is indicated for single use. The device is not provided sterile.

Not Found

This document is an FDA clearance letter for the ClearMask Transparent Surgical Face Mask (K200576). It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA did not require the manufacturer to conduct new clinical trials to demonstrate safety and effectiveness for this type of device. Substantial equivalence is often established by showing that the new device has the same intended use and technological characteristics as a predicate device, or if there are differences, that those differences do not raise new questions of safety or effectiveness.

Therefore, I cannot provide the requested information because the provided text does not describe:

1. Acceptance criteria and reported device performance: This information would typically be found in a performance study report, which is not part of this clearance letter.
2. Sample size for test set and data provenance: No test set is described.
3. Number of experts used to establish ground truth and qualifications: Ground truth establishment is not discussed.
4. Adjudication method: Not applicable as no test set or ground truth establishment is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
6. Standalone performance study: No such study is mentioned.
7. Type of ground truth used: Not applicable as no ground truth is established.
8. Sample size for the training set: Not applicable as a training set for an AI/algorithm is not discussed.
9. How ground truth for the training set was established: Not applicable.

The document is a regulatory approval notice, not a scientific study report.

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