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NaturaZ Series is used in the manufacture of dental prosthetics. The Dental Solution, Inc. proposes that the materials distributed within the United States be labeled: 'CAUTION: Federal (US) law restricts the sale of this device to, or on the order of, licensed professionals."

NaturaZ Series is a pre-formed material for use by dental laboratories. NaturaZ Series is used in the manufacture of dental prosthetics.

The NaturaZ Series is a pre-formed material for use in the manufacture of dental prosthetics. This 510(k) summary indicates that no performance data was required to demonstrate substantial equivalence to a predicate device (KaVo Everest® ZS-Blank K032081). The claim of substantial equivalence is based on comparisons of formulations and intended uses.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted from the provided text, as no such study was conducted or required.

Here's a breakdown of why each section of your request cannot be fulfilled based on the provided text:

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

• Cannot be extracted: The document explicitly states "PERFORMANCE DATA: Non Required." and bases its clearance on equivalence to a predicate device via formulation and intended use comparison, not on meeting specific performance criteria demonstrated through testing.

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

• Cannot be extracted: No performance study with a test set was conducted or required.

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)

• Cannot be extracted: No test set or ground truth establishment was performed, as no performance study was required.

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

• Cannot be extracted: No test set or adjudication method was used.

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

• Cannot be extracted: This device is a material for dental prosthetics, not an AI or imaging device, so an MRMC study is not applicable and was not performed.

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

• Cannot be extracted: This device is a material, not an algorithm.

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

• Cannot be extracted: No ground truth was established, as no performance study was conducted.

8. The sample size for the training set

• Cannot be extracted: This device is a material, not a machine learning model; therefore, no training set was used.

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

• Cannot be extracted: No training set or ground truth for a training set was established.

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