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Light curing resin in form of contoured wafers for the fabrication of custom trays.

Light curing resin in form of contoured wafers

The provided document is a 510(k) clearance letter for the Fastray LC device and its indications for use. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain specific details about acceptance criteria, device performance studies, or ground truth establishment.

Therefore, I cannot extract the requested information regarding:

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 their qualifications
4. Adjudication method for the test set
5. Multi reader multi case (MRMC) comparative effectiveness study results
6. Standalone performance study 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

The letter primarily focuses on regulatory approval based on substantial equivalence. Detailed performance data, study designs, and ground truth methodologies are typically found in the 510(k) submission document itself, which is not provided here.

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