(60 days)
This device is a "white" colored, casting alloy for use in full coverage and onlay prosthetic devices.
"white" colored, casting alloy
The provided FDA letter and associated documents for K972534, "White" Colored, Casting Alloy, do NOT contain the information necessary to describe acceptance criteria or a study proving device performance as requested.
This document is a 510(k) clearance letter, which states that the device is substantially equivalent to a predicate device already on the market. It does not typically include detailed performance study results or acceptance criteria for a new device.
Therefore, I cannot provide the requested table or answer the specific questions regarding performance studies, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information is not part of this specific FDA communication.
§ 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.