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Light Activation System for Dental Restorative Resins Visible Inspection of the Oral Cavity

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I'm sorry, but this document does not contain the acceptance criteria or study information you are looking for.

The provided text is an FDA 510(k) clearance letter for a device called "TransCure" (an Ultraviolet Activator for Polymerization). This letter confirms that the device has been found substantially equivalent to a predicate device and can be marketed.

However, it lacks the following crucial information required to answer your request:

• Acceptance Criteria and Reported Device Performance Table: This type of detail is typically found in the 510(k) submission itself or a separate performance study report, not in the clearance letter.
• Details of any study: The letter only mentions the device's classification and its substantial equivalence to a predicate. It does not describe any specific studies (e.g., clinical trials, bench tests, or comparative effectiveness studies) conducted to establish performance.
• Information about sample sizes, data provenance, expert qualifications, ground truth, or adjudication methods. These are elements of a detailed study report.

Therefore, I cannot fulfill your request based on the provided text.

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