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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

Discussion from the document regarding meeting criteria: "The major components of the two alloys are identical and their concentration is the same. The only difference is in the small amount of Zn and the grain refiners such as Ru and Ir. These minor differences have negligible effect upon the alloys."

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify a "sample size" in terms of a population of patients or cases. Instead, the "test set" consists of comparing the properties of the new alloy (Aurecast 10) against the properties of the predicate alloy (Aurolite CB-25). It implies that samples of both alloys were characterized to obtain the reported values.
• Data Provenance: The document does not state the country of origin for the data. The manufacturer, Aurex Precious Metal Industries, is based in the Republic of South Africa. The testing methods applied are "as in ANSI/ADA 5 and ISO 8891," which are international standards for dental casting alloys. The data would be derived from laboratory characterization of the alloys, not from a retrospective or prospective patient study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This is not applicable. For material science comparisons, "ground truth" is typically established by standardized laboratory measurements and characterization techniques, not by expert consensus on clinical data. The standards (ANSI/ADA 5 and ISO 8891) dictate the methodology.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• This is not applicable. Adjudication methods like 2+1 or 3+1 are used for human review of clinical data to establish a consensus ground truth. For material properties, the "adjudication" is inherent in the standardized measurement process and the comparison of the measured values.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• This is not applicable. An MRMC study is relevant for AI-powered diagnostic or assistive devices involving human interpretation of images or other clinical data. This submission pertains to a dental casting alloy, which is a material, not a device with AI interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• This is not applicable. This is not an algorithm or software device that would have "standalone performance."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for this submission are the measured physical and mechanical properties and chemical composition of the alloys, determined through standardized laboratory tests (ANSI/ADA 5 and ISO 8891).

8. The sample size for the training set:

• This is not applicable. There is no "training set" as this is not an AI/ML device or a device requiring a clinical study with training data.

9. How the ground truth for the training set was established:

• This is not applicable, as there is no training set.

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