(48 days)
Bright Gold alloy intended to be used for inlays ,single crown and 3 unit anterior bridges.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental alloy named "Bright Gold." It does not describe the acceptance criteria or a study that proves the device meets those criteria from an AI/algorithm perspective.
Instead, this document is related to a conventional medical device (a dental alloy) and its clearance is based on substantial equivalence to a legally marketed predicate device, rather than performance against pre-defined acceptance criteria for an AI model.
Therefore, I cannot extract the requested information from this document. The questions you've asked are specific to AI/Machine Learning device studies and their performance validation, which is not covered in this FDA clearance letter for a physical material.
§ 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.