(66 days)
to pierce the skin in the practice of acupuncture by the states.
DISPOSABLE ACUPUNCTURE NEEDLE
I am unable to answer your request. The provided text is a 510(k) clearance letter from the FDA for an acupuncture needle, and it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions you've asked. The document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not detail the technical performance evaluation or study design typically associated with demonstrating how a device meets specific acceptance criteria.
§ 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.