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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) premarket notification for a dental casting alloy named "Aurecast 4". This document describes the device, its intended use, and compares its technological characteristics to a legally marketed predicate device ("Argen Argenco 9").

However, the document does not describe a study in the context of typical AI/medical device performance evaluation (e.g., clinical trial data, diagnostic accuracy studies). Instead, it relies on a comparison of a material's physical and chemical properties to a predicate device to establish substantial equivalence. Therefore, many of the requested sections regarding AI device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment are not applicable.

Here's how the available information from the document addresses the request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Substantial Equivalence: The unspoken acceptance criterion is that the new device's composition and physical/mechanical properties must be "practically identical" or fall within acceptable ranges similar to the legally marketed predicate device (Argenco 9) as demonstrated by the comparison tables provided. The FDA's letter states the device was found "substantially equivalent."

2. Sample size used for the test set and the data provenance
Not applicable. This is not a study assessing diagnostic performance or clinical outcomes on a patient test set. The "test" performed involved material characterization tests (per ANSI/ADA 5 and ISO 8891) on the Aurecast 4 alloy itself, and the results were compared to the established properties of the predicate device. The document does not specify the number of samples of the alloy tested for its properties or the provenance of this test data beyond the general mention of "test methods applied."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no "ground truth" in the clinical sense of expert assessment for a patient-related dataset. The "ground truth" in this context refers to the measured material properties of the alloy and its predicate, established via standardized physical and chemical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 3.

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 device or a diagnostic device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a material (dental alloy), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the objectively measured physical and chemical properties of the material (Aurecast 4) and its comparison to the established properties of the predicate device (Argenco 9). These properties are determined through standardized test methods (ANSI/ADA 5 and ISO 8891).

8. The sample size for the training set
Not applicable. There is no training set as this is not an AI/machine learning device.

9. How the ground truth for the training set was established
Not applicable. There is no training set.

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