(32 days)
This device is a "white" colored, soldering (welding) alloy for use in the construction and repair of crown and bridge dental prostheses.
This device is a "white" colored, soldering (welding) alloy for use in the construction and repair of crown and bridge dental prostheses.
This document is a 510(k) premarket notification letter from the FDA regarding a dental solder, Vera PD Solder. It states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls and regulations.
Based on the provided text, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This letter is a regulatory approval document, not a study report.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test set or data provenance.
- Number of experts or their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How 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.