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This device is a "yellow-gold" colored, soldering alloy for use in the construction and repair of crown and bridge dental prosthetic devices. According to 21 CFR Ch. 1 (4-1-89 Ed.) Part 872. the classification name for this device is Gold Based Alloy and Precious Metal Alloys for Clinical Use, a Class II device.

"yellow-gold" colored, soldering alloy

This is a 510(k) premarket notification letter from the FDA regarding a "Yellow-Gold" Colored, Soldering Alloy (Trade Name: Aalba Gold Solder) from Aalba Dent, Incorporated. This document is a clearance letter, not a study report, so it does not contain the specific information requested about acceptance criteria and device performance studies.

Therefore, I cannot provide the requested information:

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. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
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

This document only states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, which allows it to proceed to the market. It references compliance with general controls provisions and Good Manufacturing Practice requirements, but does not detail specific performance studies conducted by the manufacturer for this clearance.

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