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Lining of ill fitting dentures Functional impression material for full dentures Impression material for construction of obturators Lining of surgical and periodontal splints Diagnostic aid to locate pressure areas on denture.

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I am sorry, but the provided text is a 510(k) clearance letter for a dental device (Coe Comfort) and does not contain the detailed information about acceptance criteria, study design, or performance metrics that you are requesting. The letter primarily states that the device has been found substantially equivalent to a legally marketed predicate device.

Therefore, I cannot extract the following information from the given text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human improvement with AI vs without AI assistance
6. If a standalone (algorithm only) performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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