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This is a yellow ceramic alloy for single units, implants prosthetics, single & 3/4 crowns, and short span bridges.

CERANUM 76 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for inlays, onlays, single crowns, bridge, implant superstructures and substrate for medium expansion with lower fusing porcelains and indirect restorative composites. CERANUM 76 is a high gold ceramic alloy, which heightens the porcelain esthetics of the restoration and provides strength, durability and color of gold.

The provided text describes a 510(k) premarket notification for a dental casting alloy, CERANUM 76. This submission aims to prove substantial equivalence to a legally marketed predicate device, Metalor's V-Supra Plus, rather than establishing acceptance criteria for a new device's performance through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth establishment is not applicable in this context.

Here's an breakdown of the relevant information provided:

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

In the context of a 510(k) for a material like a dental alloy, acceptance criteria are generally established by demonstrating similarity to a predicate device's characteristics and meeting recognized standards.

The acceptance criteria here are implicitly the values of the predicate device. The device "meets" the criteria by demonstrating sufficiently similar characteristics, even if there are some differences, as stated in the conclusion: "Despite minor differences in the materials, we believe that CERAUM 76 is a substantially equivalent to Metalor's V-Supra Plus. These changes do not affect safety or effectiveness." The submission also notes "Test methods applied: as in ANSI/ADA 5 and ISO 9693," indicating compliance with recognized standards.

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

• Sample Size: Not explicitly stated as a separate "test set" in the context of a clinical study. The data presented are material properties, likely derived from laboratory testing of material samples. The exact number of samples tested to determine these averages is not provided.
• Data Provenance: The data appears to originate from laboratory testing of the CERANUM 76 alloy and the predicate device (Metalor's V-Supra Plus). There is no indication of country of origin for the data or whether it is retrospective or prospective, as it's not a clinical study involving human or animal subjects.

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

This is not applicable. Ground truth, in this context, would not be established by medical experts. The "truth" for material properties is determined through standardized physical and chemical testing.

4. Adjudication method for the test set:

Not applicable. There is no adjudication method described as this is not a study involving subjective interpretations or multiple readers.

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 a submission for a dental alloy, not an AI-powered diagnostic device, so MRMC studies and concepts of AI assistance are not relevant.

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

Not applicable. This is a material science characterization, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the material properties (composition, melting point, hardness, yield strength, elongation, CTE) is quantitative measurement data obtained through standardized laboratory testing according to ANSI/ADA 5 and ISO 9693. This is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI context, so there is no "training set."

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

Not applicable, as there is no training set.

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