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Z Bond and Prelude One are a Primer and adhesive used for:

• Conditioning of zirconia, alumina, and metal definitive restorations prior to cementation, . e.g., crowns, posts, inlays, and onlays.
• Adhesive repair of defects in zirconia, alumina, metal and composite restorations . currently affixed to a patient's dentition.
• . Adhesive for bonding composites and other dental restorative materials to enamel or dentin.

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I am sorry, but the provided text is a 510(k) premarket notification letter and "Indications for Use Form" from the FDA concerning dental bonding agents (Z Bond and Prelude One).

It does not contain information about:

• Acceptance criteria for a device performance study.
• Details of a study proving device meets acceptance criteria (experimental design, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details).

Therefore, I cannot fulfill your request based on the provided text.

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Prelude One is a light cured adhesive designed for direct restorations, i.e. composites and compomers to enamel and/or dentin, composite repairs, porcelain repairs and post and core build-up materials, and indirect restorations such as veneers, onlays, inlays, crowns and bridges.

Prelude One is a dental bonding agent used to restore all classes of cavities

The provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for a dental bonding agent (Prelude One) and primarily focuses on its substantial equivalence to predicate devices, intended use, and regulatory classification. It does not include details about device performance tests, clinical studies, or specific acceptance criteria.

Therefore, I cannot provide the requested information in the table or answer the specific questions about studies, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.

Ask a specific question about this device