Search Results

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

Palladium silver based casting alloy

Here's an analysis of the provided text regarding the Palceram 56 dental casting alloy, addressing your request for acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device seeking market clearance in the US. For such devices, often the "study" proving acceptance criteria is a comparison to a legally marketed predicate device demonstrating substantial equivalence, rather than a standalone clinical trial in the way a pharmaceutical might have. This document primarily focuses on demonstrating that the new device is as safe and effective as an existing one through comparison of material properties.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" here are implicitly linked to the properties of the legally marketed predicate device, "Aurium Aurolite IK." The new device, "Palceram 56," is considered acceptable if its properties are comparable or within acceptable ranges relative to the predicate. The document doesn't explicitly state numerical acceptance thresholds for each property, but rather presents a side-by-side comparison to demonstrate similarity.

Discussion: The conclusion states: "Identical main elements and the similarity of their content can result in similar chemical and biological effect." This implies that despite some numerical differences in mechanical properties, the overall "similarity" is deemed sufficient for regulatory acceptance, especially given the "minor concentration of Fe vs. Zn" for trace elements and the fact that the device meets industry standards (ANSI/ADA 5 and ISO 9693). The differences in 'soft' vs 'hard' for some properties are likely related to how the alloy is processed/used in practice.

Study Details (Based on available information)

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

• Sample Size: Not explicitly stated. For material testing like this, it would involve a certain number of specimens of the alloy for each test (e.g., tensile strength, hardness, etc.). The document doesn't provide these specific specimen counts.
• Data Provenance: The data comes from the manufacturer, Aurex Precious Metal Industries (PTY) Ltd. of South Africa ("Republic of South Africa" listed as country of origin). The testing seems to be based on adherence to international standards (ANSI/ADA 5 and ISO 9693), which implies standardized laboratory testing. It is retrospective in the sense that the data represents characterization of the material after its development.

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

• This type of submission (510(k) for material equivalence) typically does not involve experts establishing "ground truth" in the clinical sense (e.g., radiologists interpreting images). Instead, the "truth" is established by the results of standardized material property tests performed according to recognized industry standards (ANSI/ADA 5 and ISO 9693). The experts involved would be materials scientists and engineers who conducted the tests and interpreted the results against those standards and the predicate device's known properties. Their qualifications are implicitly that they are capable of performing and interpreting these technical tests.

4. Adjudication method for the test set:

• Not applicable as this is not a subjective interpretation task requiring adjudication. The "adjudication" is performed by comparing the quantifiable test results to the predicate device and relevant standards.

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:

• No. This is a material science characterization for a dental alloy, not an AI-powered diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is relevant here.

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

• No. As above, this is not an algorithm or software device.

7. The type of ground truth used:

• Objectively measured material properties obtained through standardized laboratory tests (e.g., melting point, hardness, yield strength, elongation, CTE, density) and elemental composition analysis. The "ground truth" for comparison is the known and characterized properties of a legally marketed predicate device and the requirements of relevant industry standards.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of material characterization unless it refers to samples used for initial development and optimization of the alloy formulation. The document does not provide details on such development.

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

• Not applicable. No training set as per the definition of AI/machine learning. The "ground truth" in material science is derived from direct measurement and adherence to established physical and chemical principles and standards.

Ask a specific question about this device