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CERCOM II Cement is a self-adhesive cement recommended for the bonding of ceramic, metal and composite restorations.

CERCOM II Cement is a self-adhesive cement recommended for the bonding of ceramic, metal and composite restorations. CERCOM II has the same technological characteristics (intended use, application mechanism) as the predicate device CERCOM, except that CERCOM II is a dual-cure cement. CERCOM II can set on its own as well as set with visible light cure.

This looks like a regulatory approval document (510(k) Summary) for a dental cement, not a study describing the performance of a medical device against acceptance criteria. Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided text.

The document states that the CERCOM II Cement is "substantially equivalent in design, composition, performance, intended use and effectiveness to the predicate cement products cited." This means it was approved based on its similarity to previously cleared devices, rather than a new standalone clinical trial with specific performance metrics and acceptance criteria.

To answer your request, I would need a document specifically detailing a performance study for a device, including its acceptance criteria and the results of that study.

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