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The Singer Acupuncture Needle is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states .

Singer Acupuncture Needle

The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Singer Acupuncture Needle." This document primarily addresses the substantial equivalence of the device to legally marketed predicate devices, allowing it to be marketed.

Crucially, this type of regulatory document does not typically include information about specific acceptance criteria and detailed study results as requested in your prompt. 510(k) clearances are based on demonstrating substantial equivalence, not necessarily on new clinical performance studies involving a pre-defined set of acceptance criteria. While the manufacturer would have performed various tests to ensure safety and performance, the details of those tests, their acceptance criteria, and specific study designs (like sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance) are not part of this public FDA clearance letter.

Therefore, I cannot extract the requested information from the provided text. The document confirms the device is an acupuncture needle, is prescription-use only, and is intended to pierce the skin in the practice of acupuncture by qualified practitioners. It does not contain any of the detailed study information you've asked for.

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