(74 days)
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
Not Found
The provided text is a U.S. FDA 510(k) clearance letter for a medical device: "C&G Acupuncture Needle." This type of document does not contain the information requested regarding acceptance criteria studies, performance data, sample sizes, expert qualifications, or ground truth establishment.
A 510(k) clearance letter primarily focuses on:
- Confirming that a new device is substantially equivalent to a legally marketed predicate device.
- Outlining the regulatory classification and general controls applicable to the device.
- Stating the intended use of the device.
To obtain the information requested, one would typically need to review the 510(k) summary document submitted by the manufacturer to the FDA, or potentially a clinical study report if such studies were conducted and summarized for the 510(k) application. These documents would detail the testing performed to demonstrate substantial equivalence, including performance data and the methods used to obtain it.
Therefore, I cannot provide the requested information based on 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.