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MonoBloc BM Series is indicated for use as a dental restoration including inlays, onlays, veneers, and crowns.

MonoBloc BM Series is glass type material used for aesthetic purposes of inlays, onlays, veneers and crowns. This looks like a block form and corresponds to ISO 6872 Type 2 Class 1. It can be fabricated using dental CAD/CAM devices such as CERECTM inLab and CERECTM MCXL.

The provided text describes the submission of a 510(k) for the "MonoBloc BM Series", a dental frame material. This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through showing that its physical characteristics meet established international standards.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the tests. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The "ground truth" for this device appears to be the specified ISO standards, rather than expert consensus on clinical cases.

4. Adjudication method for the test set

This information is not provided. Given that the evaluation is against ISO standards for physical characteristics, a traditional adjudication method for clinical data is not applicable here.

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

An MRMC comparative effectiveness study was not conducted. This device is a material for dental prostheses, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of human reader improvement with or without AI assistance is not relevant.

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

This is not applicable. The device is a material, not an algorithm.

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

The ground truth used for evaluating the MonoBloc BM Series is the criteria set by international standards (ISO 6872 and ISO 9693) for dental materials.

8. The sample size for the training set

This information is not applicable. The device is a material, not a machine learning algorithm that requires a "training set."

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

This information is not applicable as there is no training set for this type of device.

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