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This device is intended to pierce skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Carbo/Optimed brand acupuncture needles are sterile disposable needle for one time use only. The needle shaft/body is made of surgical grade stainless steel (as per ASTM specifications) and is used for the practice of acupuncture as determined by state. The handle is made of aluminium alloy, which does not enter the human body, but is used to control the insertion of the needle.

The provided text is a 510(k) premarket notification summary for an acupuncture needle. It explicitly states that "Substantial equivalence is not based on an assessment of performance data."

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, and comparative effectiveness studies is not available in this document.

The submission focuses on demonstrating substantial equivalence to predicate devices (Tai-Chi Acupuncture needles K003760 and Addiquip Acupuncture needles K981272) based on design, intended use, and technological characteristics (sterile disposable, surgical grade stainless steel shaft, aluminum alloy handle). No clinical studies or performance data are presented to establish acceptance criteria or prove that the device meets them.

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