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Light Activation System for Dental Restorative Resins

SunliteLED Model #2810

The provided document is a 510(k) clearance letter from the FDA for a dental device called "SunliteLED Model #2810." This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, a 510(k) clearance letter does not contain information about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert qualifications in the detailed format requested. This type of information is typically found in the 510(k) submission itself, or in supporting technical documentation and study reports, which are not part of this public clearance letter.

The letter explicitly states: "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies." It focuses on regulatory compliance and substantial equivalence to a predicate device, rather than providing a detailed performance study report.

Therefore, I cannot provide the requested information based solely on the text provided. The document confirms the device name, applicant, regulation number, and indications for use, but not the specific technical performance details of a study with acceptance criteria.

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