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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

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