(66 days)
Dental casting alloy for making dental restorations and appliances.
Low gold, silver-palladium based casting alloy
The provided document is a 510(k) summary for a dental casting alloy, Aurecast 10, seeking substantially equivalent status to a predicate device, Aurium Aurolite CB-25. The document does not describe a study or acceptance criteria in the context of device performance as typically applied to AI/ML medical devices, or medical devices requiring extensive clinical trials. Instead, it focuses on demonstrating substantial equivalence based on material composition and physical/mechanical properties.
Therefore, many of the requested elements for describing an acceptance criteria study (e.g., sample size for test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are not applicable to this type of submission.
Here's an interpretation based on the provided document, addressing the relevant points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (New Device: Aurecast 10) |
|---|---|
| Composition (weight%) | Composition (weight%) |
| Au: 10 | Au: 10 |
| Ag: 59.9 | Ag: 59.9 |
| Pd: 20 | Pd: 20 |
| Cu: 9 | Cu: 9 |
| Zn: |
§ 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.