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To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the States.

Marknew Products Acupuncture Needles

I apologize, but the provided text is a 510(k) clearance letter from the FDA for acupuncture needles. It does not contain any information about acceptance criteria for a device, a study proving device performance, or any of the specific details requested in your prompt (like sample sizes, ground truth establishment, or expert qualifications).

Therefore, I cannot fulfill your request based on the given input.

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To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the States

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This document is a 510(k) clearance letter from the FDA for Marknew Products Acupuncture Needles. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter primarily addresses the substantial equivalence of the device to legally marketed predicate devices, allowing it to proceed to market.

Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval, not a scientific study report.

Ask a specific question about this device