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Cervitec Plus is a dental varnish material that is used for the protection of exposed root surfaces and treatment of hypersensitive cervicals

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The provided document is a 510(k) premarket notification letter from the FDA for a dental varnish called "Cervitec Plus." This type of document is for a medical device that demonstrates substantial equivalence to a legally marketed predicate device, rather than a novel device. Therefore, it does not contain the kind of study information and acceptance criteria typically associated with novel AI/ML device submissions.

The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.) is specific to the rigorous testing and validation of new medical devices, particularly those incorporating AI or complex algorithms. This 510(k) letter primarily confirms that the device meets existing general controls for safety and efficacy based on its similarity to a predicate device.

Thus, based on the provided document, I cannot fulfill the request as it pertains to acceptance criteria and a study demonstrating device performance in the way described in the prompt. The document only confirms the FDA's "substantial equivalence" determination for the Cervitec Plus dental varnish.

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