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CEREC Opti Spray is indicated as a coating medium for optical impressions with the CEREC system. It aids in intraoral topographical recordings of prepared and unprepared teeth and their surrounding.

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This document is an FDA 510(k) clearance letter for a dental impression spray. As such, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria. The letter primarily states that the device, "CEREC Opti Spray," has been found substantially equivalent to legally marketed predicate devices, which allows it to proceed to market.

The document does not include:

• A table of acceptance criteria and reported device performance.
• Information on sample size, data provenance, or the number/qualifications of experts for a test set.
• Adjudication methods.
• Details of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size.
• Information on a standalone (algorithm only) performance study.
• The type of ground truth used.
• Sample size for a training set or how its ground truth was established.

Therefore, I cannot provide the requested information based on the text provided. This document is a regulatory approval, not a scientific study report.

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