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For use to ensure three-dimensional reconstruction of alveolar bone defects and to facilitate augmentation with adequate fixation of the augmentation material.

Cytoflex Mesh is a precision titanium mesh of a specific dimension and pore size. Cytoflex Mesh is supplied in specific sizes and thickness in sealed pouches. Cytoflex Mesh is tested, evaluated and found to be substantially equivalent to legally marketed predicate devices.

The provided text describes a medical device, the Cytoflex Mesh, and its 510(k) summary for FDA clearance. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of the device.

This document is solely focused on the regulatory clearance process for a predicate device, establishing substantial equivalence based on device description and intended use, rather than a performance study with quantitative acceptance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance results
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

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