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Red light: Treatment of full-face wrinkles.

• Yellow light: Treatment of full-face wrinkles.
• Red+Infrared light: Treatment of full-face wrinkles.
• Blue light: Treatment of mild to moderate inflammatory acne.
• Mixed light (Red+Blue+Infrared): Treatment of mild to moderate inflammatory acne.

Not Found

I am sorry, but based on the provided FDA 510(k) Clearance Letter for the "LED Light Therapy Mask," there is no information regarding acceptance criteria or a study proving the device meets specific performance criteria for efficacy in treating wrinkles or acne.

The FDA 510(k) clearance process primarily establishes substantial equivalence to a predicate device already on the market, not necessarily a demonstration of clinical efficacy through specific performance metrics or a detailed clinical study demonstrating the type of information you've requested (e.g., sample size, expert adjudication, MRMC studies, specific ground truth methods).

The letter confirms regulatory clearance and lists the stated indications for use (treatment of full-face wrinkles with red, yellow, and red+infrared light; treatment of mild to moderate inflammatory acne with blue and mixed light). However, it does not contain the detailed study design, acceptance criteria, or performance data you are looking for.

Therefore, I cannot populate the table or answer the specific questions about the study design because that information is not present in the provided document.

To answer your questions, one would typically need access to the 510(k) submission document itself, or summaries of the clinical data provided within that submission, which are often not fully disclosed in the public clearance letter.

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