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• treatment of hypersensitive dentine
• treatment of cervical areas (including crown margins, after tooth cleaning or tartar removal, exposed cervical areas etc.)

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This document is a 510(k) clearance letter from the FDA for a dental device called "Admira Protect and Admira Protect Single Dose." It does not contain any information about acceptance criteria or a study proving device performance against such criteria.

The letter is a regulatory approval document confirming that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It details:

• Device Name: Admira Protect and Admira Protect Single Dose
• Regulation Number and Name: 872.3765, Pit and Fissure Sealant and Conditioner
• Regulatory Class: II
• Product Code: EBC
• Date of Approval: July 21, 2006
• Indications for Use:
  • Treatment of hypersensitive dentine
  • Treatment of cervical areas (including crown margins, after tooth cleaning or tartar removal, exposed cervical areas, etc.)

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This information would typically be found in the 510(k) submission summary or a separate clinical study report, not in the clearance letter itself.

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• treatment of hypersensitive dentine
• treatment of cervical areas (including crown margins, after tooth cleaning or tartar removal, exposed cervical areas etc.)

Not Found

The provided text is an FDA 510(k) clearance letter for a dental device, "Admira Protect." It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria as typically understood for medical device performance evaluation using AI.

The letter simply states that the FDA has reviewed the 510(k) premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This indicates a regulatory clearance process rather than a performance study with defined acceptance criteria and results.

Therefore, I cannot extract the requested information from the provided document. The document primarily focuses on regulatory approval based on substantial equivalence, and not on detailed performance study results against specific acceptance criteria.

Ask a specific question about this device