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Vitablocs® are indicated for use as a dental restoration including inlays, onlays, veneers, crowns and bridges.

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I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the Vitablocs® device, which is a dental restoration material.

This document primarily states that the device has been found substantially equivalent to predicate devices and outlines regulatory requirements. It does not contain any information about specific acceptance criteria, study designs, sample sizes, ground truth establishment, or any performance data of the device itself.

Therefore, I cannot provide the requested information, including the table of acceptance criteria and reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

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Vitablocs® are indicated for use as a dental restoration including inlays, onlays, veneers and crowns.

Not Found

I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for Vitablocs®, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as registration, labeling, and good manufacturing practices, and specifies the indications for use.

However, it does not include:

1. A table of acceptance criteria or reported device performance.
2. Details about sample sizes, data provenance, or ground truth for any studies.
3. Information about experts, adjudication methods, or MRMC comparative effectiveness studies.
4. Information about standalone algorithm performance or training sets.

Therefore, I cannot fulfill your request based on the given input.

Ask a specific question about this device