(195 days)
The Singer Acupuncture Needle is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states .
Singer Acupuncture Needle
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Singer Acupuncture Needle." This document primarily addresses the substantial equivalence of the device to legally marketed predicate devices, allowing it to be marketed.
Crucially, this type of regulatory document does not typically include information about specific acceptance criteria and detailed study results as requested in your prompt. 510(k) clearances are based on demonstrating substantial equivalence, not necessarily on new clinical performance studies involving a pre-defined set of acceptance criteria. While the manufacturer would have performed various tests to ensure safety and performance, the details of those tests, their acceptance criteria, and specific study designs (like sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance) are not part of this public FDA clearance letter.
Therefore, I cannot extract the requested information from the provided text. The document confirms the device is an acupuncture needle, is prescription-use only, and is intended to pierce the skin in the practice of acupuncture by qualified practitioners. It does not contain any of the detailed study information you've asked for.
§ 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.