(64 days)
Bio Universal alloy intended to be used for crowns, posts, short and long span bridges and PFM crowns.
Bio Universal
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental alloy device (BioUniversal). This type of document does not contain information about acceptance criteria for a medical device's performance, nor does it describe a study proving the device meets such criteria in the context of AI or advanced analytical performance.
The document is a regulatory approval notice, confirming that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed. It discusses regulatory classifications, general controls, and compliance requirements, but does not delve into specific performance metrics or studies of the type you've outlined (e.g., diagnostic accuracy, expert consensus, training sets for AI).
Therefore, I cannot extract the requested information from the provided text.
§ 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.