(73 days)
Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Not Found
The provided text is a 510(k) premarket notification approval letter for acupuncture needles. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, ground truth types, or training set details) from the provided document.
§ 880.5580 Acupuncture needle.
(a)
Identification. An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.(b)
Classification. Class II (special controls). The device, when it is an acupuncture point locator or a single use acupuncture needle, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. Acupuncture needles must comply with the following special controls:(1) Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109,
(2) Device material biocompatibility, and
(3) Device sterility.