(79 days)
Acupuncture needles are defined as devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
The subject of this 510(k) application - the CW acupuncture needle - is a sterile, single use only acupuncture needle. The CW acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
The provided text is a 510(k) summary for an acupuncture needle, not a study evaluating an AI/ML device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, study design, expert involvement, or AI performance metrics.
The document focuses on demonstrating substantial equivalence of the "CW acupuncture needle" to legally marketed devices, primarily by highlighting its sterile, single-use nature and its history of safe use. It explicitly states: "The CW acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture." However, it does not detail specific quantitative acceptance criteria or a formal study with a test set, ground truth, or expert review that would typically be associated with performance evaluation of an AI/ML device.
Therefore, I cannot provide the requested table and information as it is not present in the given 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.