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

FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE

This document is a 510(k) clearance letter from the FDA for an acupuncture needle and does not contain information about acceptance criteria or a study proving device performance as typically seen for AI/ML medical devices. The document essentially states that the device is substantially equivalent to a legally marketed predicate device, which is the basis for its clearance, rather than presenting de novo performance study results against specific acceptance criteria.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance results) from the provided text.

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