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510(k) Data Aggregation
(182 days)
AURELUX 77
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
High gold casting alloy
The provided document is a 510(k) summary for a dental casting alloy, AURELUX 77. This document focuses on demonstrating substantial equivalence to a predicate device (Jelenko Jel 96) rather than proving device performance against specific acceptance criteria in a clinical or standalone study as one would expect for an AI/CADe device.
Therefore, the information required to answer the prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not present in this document because it describes the submission of a material device, not a software or AI-driven device.
However, I can extract the comparison data between the new device and the predicate device, which serves as the "performance" demonstrated for this type of submission.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this type of device are intrinsic to demonstrating "substantial equivalence" to a legally marketed predicate device. This means the new device's characteristics should be similar enough to the predicate device that it doesn't raise new questions of safety or effectiveness. The comparison table below effectively acts as the "performance" data against these implicit acceptance criteria of substantial equivalence.
| Characteristic | Acceptance Criteria (Predicate: Jel 96) | Reported Device Performance (Aurelux 77) |
|---|---|---|
| Composition (weight%) | ||
| Au | 78 | 76.6 |
| Ag | 1.2 | 1.2 |
| Pt | 6 | 9.9 |
| Pd | 12 | 9.3 |
| Cu | 4.5 | 0.5 |
| Fe | 1 | 0.2 |
| Sn | x ( 95% (implied by individual components) | > 95% (as stated in discussion) |
| Base metal concentration | Implied by individual components |
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