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Fabrication of 24 karat 99.96% pure gold substructure for porcelain fused to metal restorations.

ProGold - Gold Electrocoping System

I am sorry, but the provided text does not contain the detailed study information required to answer your request about acceptance criteria and device performance. The document is a 510(k) clearance letter from the FDA for a dental system called "ProGold - Gold Electrocoping System." It states that the device is substantially equivalent to previously marketed devices but does not include any specifics about clinical studies, performance metrics, acceptance criteria, or sample sizes.

Therefore, I cannot extract the following information:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes 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
6. If a standalone 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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