(174 days)
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.
§ 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.