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For use as a periodontal wound dressing to protect injured periodontal tissue by forming a barrier to avoid further irritation.

The product is a periodontal wound dressing. It is intended for use only by dental practitioners; and will not be offered for OTC use. It contains materials that pose no health hazard when used according to directions.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary and an FDA clearance letter for a device called "Reso-Pac," a periodontal wound dressing.

It primarily discusses:

• The manufacturer and submitter details.
• The product's intended use and substantial equivalence to predicate devices.
• FDA's clearance of the device for marketing.
• Regulatory requirements and contacts.
• Indications for use.

There is no mention of:

• Specific performance metrics or acceptance criteria (e.g., sensitivity, specificity, accuracy).
• Any study design, test sets, training sets, ground truth establishment, expert qualifications, or adjudication methods for evaluating the device's performance against such criteria.
• A multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.

Therefore, I cannot provide the requested information based on the input text.

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