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

Low gold palladium based casting alloy

The provided text describes a 510(k) summary for a dental casting alloy named PALAUREX 78, seeking to establish its substantial equivalence to a legally marketed device, Jelenko Freedom Plus. It is not a study proving a device meets acceptance criteria in the typical sense of a clinical or performance study with defined performance metrics like sensitivity, specificity, or reader improvement. This document is a pre-market notification to the FDA, demonstrating that a new device is as safe and effective as a predicate device.

Therefore, the requested information elements such as "sample size for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," and "standalone performance" are not applicable to this type of submission. This submission focuses on comparing the new device's technological characteristics (composition and physical/mechanical properties) to a legally marketed predicate device.

Here's the information that can be extracted from your input, framed within the context of substantial equivalence rather than traditional acceptance criteria:

1. Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this 510(k) submission are not explicit numerical thresholds for clinical performance (like accuracy metrics). Instead, the acceptance criterion is demonstrating substantial equivalence to the predicate device, Jelenko Freedom Plus, by showing similar technological characteristics and an expectation of similar biological effect and intended use. The "reported device performance" is a comparison of these characteristics.

Discussion from the document:

• "The noble content metal is high (80%) in both alloy, with almost identical breakdown to the respective elements."
• "Palaurex 78 has two base metal elements, Cu and Ga; Freedom Plus has In as well."
• Conclusion: "On the basis of the identical major elements and high noble metal content similar biological effect may be expected from both alloys."

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

• Sample Set: Not applicable in the context of a clinical test set. The "test set" here refers to the actual alloy samples of PALAUREX 78 that were subjected to the specified physical and mechanical tests. The exact number of samples tested for each property is not disclosed, but it would have been sufficient to perform the tests as per the cited standards (ANSI/ADA 5 and ISO 9693).
• Data Provenance: The device manufacturer, Aurex Precious Metal Industries (PTY)-LTD., is based in the Republic of South Africa. The testing would have been conducted to international standards (ANSI/ADA 5 and ISO 9693), implying a laboratory setting for material characterization. This is a retrospective analysis of the material's properties based on standardized lab tests.

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

• Not Applicable. Ground truth, in the sense of expert consensus on clinical findings, is not relevant for this material characterization submission. The "ground truth" for the material properties (e.g., melting point, hardness) is established by the standardized test methods themselves (ANSI/ADA 5 and ISO 9693) which are internationally recognized protocols for material characterization. Compliance with these standards is considered the "truth."

4. Adjudication method for the test set

• Not Applicable. Adjudication methods like '2+1' or '3+1' are used for resolving discrepancies in expert interpretations of clinical data. This submission relies on objective, quantifiable material properties measured according to established standards, not subjective 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 a submission for a dental casting alloy, not an AI-powered diagnostic device or a system involving human readers.

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

• Not Applicable. This is a dental material, not an algorithm.

7. The type of ground truth used

• The "ground truth" for the performance claims (compounds, mechanical and physical properties) is derived from standardized laboratory testing methods (ANSI/ADA 5 and ISO 9693). These standards define how to measure these properties precisely and objectively.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this material property comparison. Machine learning or AI models, which typically require training sets, are not involved.

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

• Not Applicable. As there is no training set, this question is not relevant.

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