(88 days)
Dental casting alloy for making restoration.
High gold casting alloy
I am sorry, but the provided text describes a 510(k) submission for a dental casting alloy named AURECAST 92. This document is a regulatory submission for a material, not a medical device that would involve a study with acceptance criteria, sample sizes, expert ground truth, or human-in-the-loop performance as you've requested.
The document focuses on comparing the AURECAST 92 alloy to a legally marketed predicate device (Argenco Bio10) based on composition, physical, and mechanical properties. The acceptance is based on the substantial equivalence of these material properties, rather than performance metrics of a device against specific clinical or diagnostic criteria.
Therefore, I cannot extract the information required for the table and bullet points you provided, as those concepts (like sample size for test sets, ground truth by experts, MRMC studies, standalone performance) are not applicable to the type of device and submission described in the 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.