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Dental casting alloy for making restoration. (NOT FOR USE WITH DENTAL PORCELAIN )

Silver-palladium based casting alloy

The document provided is a 510(k) premarket notification for a dental casting alloy, not a medical device that utilizes an algorithm or AI. Therefore, the concepts of acceptance criteria for algorithm performance, study design with human readers, ground truth, and training/test sets are not applicable.

The "acceptance criteria" in this context refer to the demonstration of substantial equivalence to a legally marketed predicate device, based on similar technological characteristics (composition, physical, and mechanical properties) and intended use.

Here's the information extracted from the document, rephrased to fit the context of device equivalence rather than algorithm performance:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly defined by the properties of the legally marketed predicate device, Jelenko Albacast. The new device, Aurecast GF, is deemed to meet these criteria if its properties are substantially similar, especially for critical attributes.

Discussion from the document:

• "The constituents above 1% are the same."
• "The concentration difference in the major component (silver) is less than 3%."
• "The base metal content is slightly less in the new alloy."
• "The mechanical properties of the two alloys are very similar..."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The "test set" in this context refers to the samples of the Aurecast GF alloy that were manufactured and tested according to ANSI/ADA 5 standards. The document does not specify the exact sample size for each test. The data provenance is South Africa, as indicated by the applicant's address. The data would be prospective, as the tests were performed on the newly manufactured Aurecast GF alloy for submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This concept is not applicable. For material science, "ground truth" is established through standardized laboratory testing (e.g., chemical analysis, mechanical property testing) using validated instruments and methods, rather than expert interpretation of data. The document references "Test methods applied: as in ANSI/ADA 5," implying adherence to recognized material testing standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Material properties are measured objectively; there is no human adjudication of results in the way image interpretation might require.

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 material comparison, not an AI-assisted diagnostic device.

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

Not applicable. This is a material comparison, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the material properties of Aurecast GF and the predicate device, Albacast, was established through standardized analytical and mechanical testing. This includes:

• Chemical composition analysis (e.g., spectroscopy)
• Melting point determination
• Hardness testing (Vickers 5/30)
• Yield strength testing
• Elongation testing
• Density measurements
  These methods, explicitly "as in ANSI/ADA 5," provide objective, measurable data as the ground truth.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. There is no training set for this type of device submission.

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