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Dental casting alloy for making restoration.

High gold casting alloy

This document describes the AURECAST 83 Dental casting alloy and its substantial equivalence to a legally marketed predicate device, Jelenko Benchmark I. The acceptance criteria and the study that proves the device meets them are based on comparisons of composition and physical/mechanical properties, not on a clinical effectiveness study with human readers or outcomes data.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" are implicitly defined by the parameters deemed important for substantial equivalence to the predicate device. The "reported device performance" is the measured performance of AURECAST 83.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a benchmarking comparison study against the legally marketed predicate device, Jelenko Benchmark I. This study involves chemical analysis and physical/mechanical property testing according to recognized industry standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a numerical sample size for the "test set" in terms of number of alloy samples tested. The data presented is characteristic property data for each alloy. It can be inferred that samples of both AURECAST 83 and Jelenko Benchmark I were produced and subjected to the specified tests.
• Data Provenance: The manufacturer, Aurex Precious Metal Industries (PTY) LTD, is located in the Republic of South Africa. Therefore, the data likely originated from testing conducted in South Africa. The study is retrospective in the sense that properties of existing alloys (the new device and the predicate) were measured and compared.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of submission (510(k) for a material like dental alloy) does not typically involve human experts establishing "ground truth" derived from clinical images or patient outcomes. The "ground truth" for the properties is established through standardized laboratory testing procedures.

4. Adjudication Method for the Test Set

Not applicable. There is no subjective interpretation or adjudication involved in measuring the physical and chemical properties of a dental alloy. The results are objective measurements from standardized tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., medical images) with and without AI assistance to assess impact on diagnostic accuracy or reader performance. AURECAST 83 is a dental casting alloy, not a diagnostic device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone performance study in the context of an "algorithm only" is not applicable. AURECAST 83 is a material, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for this submission is objective, measurable physical and chemical properties determined through standardized laboratory tests (as in ANSI/ADA 5 and ISO 1562). This is not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of developing a material like a dental alloy. This submission relies on direct comparison of manufactured product properties to a predicate, not on a machine learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a material like this.

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