(53 days)
To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the States.
Marknew Products Acupuncture Needles
I apologize, but the provided text is a 510(k) clearance letter from the FDA for acupuncture needles. It does not contain any information about acceptance criteria for a device, a study proving device performance, or any of the specific details requested in your prompt (like sample sizes, ground truth establishment, or expert qualifications).
Therefore, I cannot fulfill your request based on the given input.
§ 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.