(19 days)
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:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size
- If a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.