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

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The provided text is a 510(k) clearance letter from the FDA for a device called "Lyra Acupuncture Needles." It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert evaluations.

The document primarily focuses on:

• Confirming that the device is substantially equivalent to legally marketed predicate devices.
• Outlining the regulatory requirements the manufacturer must adhere to (e.g., registration, labeling, good manufacturing practice).
• Stating the intended "Indications For Use" for the device, which is "To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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