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Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.

Medium gold palladium based casting alloy

The provided text is a 510(k) summary for a dental casting alloy named HIPALLAUR 51. This document describes the device and compares it to a legally marketed predicate device (Jelenko Cameo) based on composition and physical/mechanical properties to demonstrate substantial equivalence. It does not describe an AI/ML device or a study with acceptance criteria and device performance in the way requested in the prompt.

Therefore, many of the requested categories are not applicable to the provided text. I will address the relevant information that can be extracted.

Not Applicable:

• A table of acceptance criteria and the reported device performance: This document is a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific, predefined acceptance criteria for a new AI/ML device performance. The "performance" here is comparison to a predicate.
• Sample size used for the test set and the data provenance: There isn't a "test set" in the context of an AI/ML device. The comparison is based on material properties.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable for a dental alloy.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a dental alloy.
• The type of ground truth used: Not applicable in the AI/ML sense. The "ground truth" for this submission is established chemical composition and physical properties measured by standard methods.
• The sample size for the training set: Not applicable for a dental alloy.
• How the ground truth for the training set was established: Not applicable for a dental alloy.

Applicable Information (based on interpretation of the prompt for a non-AI/ML device):

The "acceptance criteria" for a 510(k) submission like this are implicitly demonstrating substantial equivalence to a legally marketed predicate device. The "device performance" is presented through direct comparison of material properties.

1. Table of Acceptance Criteria and the Reported Device Performance

For this 510(k) submission, the implicit "acceptance criteria" are that the new device (HIPALLAUR 51) has a composition and physical/mechanical properties that are sufficiently similar to the legally marketed predicate device (Jelenko Cameo) to ensure equivalent safety and effectiveness.

Here's a table synthesizing the comparison presented:

Summary of the study/comparison:
The study demonstrates that "All the elements above 1 % are the same in both alloys. The difference in concentration for every component is less than 5 %. The elements under 1 % content are either noble ones, or the ones that oxidize and be eliminated during melting. Consequently, they have little effect upon the characteristics of the alloys." The conclusion states, "Up to 99 % both alloy consist of the same elements. This suggests that chemical and biological behaviour should be similar."

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

The document does not specify a "sample size" in the context of a statistical study for device performance. The data provenance is from the manufacturer, Aurex Precious Metal Industries (PTY) LTD., based in the Republic of South Africa. The data appears to be based on laboratory testing of material properties, rather than clinical trials with human subjects. The data is retrospective in the sense that the predicate device's data is existing, and the new device's data is measured for comparison.

6. If a standalone was done:
Yes, the comparison of the HIPALLAUR 51 alloy's composition and physical/mechanical properties, as measured according to ANSVADA 5 and ISO 9693 standards, is a standalone assessment of the device's characteristics against those of the predicate device. There is no human-in-the-loop component for evaluating the performance of a dental alloy.

7. The type of ground truth used:
For the purpose of this 510(k) submission, the "ground truth" is established by:

• Chemical Analysis: Determining the exact elemental composition (weight%) of both the predicate and new alloys.
• Standardized Physical/Mechanical Property Testing: Measurements of properties like melting point, hardness, yield strength, elongation, CTE, and density, conducted according to recognized industry standards (ANSVADA 5 and ISO 9693). These standards define the accepted methods for obtaining these measurements, ensuring consistency and reliability of the "ground truth" data.

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