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Dental casting alloy for making dental restorations and appliances.
FOR USE WITH DENTAL PORCELAIN NOT (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division ! 510(k) Number
Prescription Use er 21 CFR 801.109)
OR
Over-The-Counter Use ------

High gold casting alloy

This report is a 510(k) summary for a dental casting alloy, not a study evaluating an AI/ML powered device. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth is not applicable.

However, I can extract information related to the comparison of the new device to a legally marketed predicate device, which can be seen as an analog to "acceptance criteria" for demonstrating substantial equivalence based on physical and chemical properties.

Here's the relevant information:

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission, the "acceptance criteria" for a new device like "Aurecast Bio 69PF" are demonstrating substantial equivalence to a legally marketed predicate device ("Jelenko Benchmark IV"). This is achieved by showing comparable composition and physical/mechanical properties. The tables below outline these comparisons.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. Standard material testing typically uses multiple specimens to ensure reproducibility, but the exact number isn't mentioned in this summary.
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. The applicant is based in South Africa.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This is a material science comparison, not a diagnostic or AI study involving human expert ground truth. The "ground truth" here is the measured physical and chemical properties.

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

• Not applicable. This is a material science testing, not a clinical trial requiring adjudication of interpretations.

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

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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

• The "ground truth" for this submission are the directly measured chemical composition (weight %) and physical/mechanical properties (melting point, hardness, yield strength, elongation, density) as determined by standardized test methods (ANSI/ADA 5 and ISO 8891).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no training set.

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

• Not applicable. This is not an AI/ML device, so there is no training set.

Summary of the study/comparison:

The "study" presented here is a direct comparison of the chemical composition and physical/mechanical properties of the new device (Aurecast Bio 69PF) against a legally marketed predicate device (Jelenko Benchmark IV). The manufacturer asserts that the "major constituents up to 98% are the same" and that the "small amount of indium... cannot cause any considerable difference." The conclusion is that "due to the similarity of the constitution it may be assumed that the chemical behaviour and the biological effect should be quite similar," thus establishing substantial equivalence. The test methods applied for these measurements were "as in ANSI/ADA 5 and ISO 8891."

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