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Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses: precious metal bridges, bars, and posts; precious metal copings, pontics and bridges for porcelain-fused-to-metal restorations. For porcelain-fused-to-metal restorations it is intended by the manufacturer that only normal-fusing-temperature porcelain products be used with the Biogold Plus alloy. After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.

Biogold Plus Dental Alloy

The provided document is a 510(k) premarket notification letter from the FDA regarding a dental alloy named "Biogold Plus Dental Alloy." This document does not contain any information about acceptance criteria or a study proving device performance. It is a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use.

Therefore, I cannot fulfill your request for descriptions of:

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

This information would typically be found in a study report or a different section of a 510(k) submission, and is not present in the provided FDA letter.

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