(94 days)
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
The Dong Bang acupuncture needle is a sterile surgical stainless steel, single use only acupuncture needle. The Dong Bang acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
The provided document is a 510(k) summary for the Dong Bang Acupuncture Needle and a subsequent FDA clearance letter. It does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document primarily focuses on establishing substantial equivalence to existing legally marketed devices, which is the basis for 510(k) clearance. The crucial aspects for your request are missing.
Therefore, I cannot provide the requested information, including the table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, types of ground truth, or training set information.
The only relevant statements from the document are:
- "The Dong Bang acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture." (This is a general claim, not supported by data in this document).
- "Since 1992, no accident or device failure claims have been reported as a result of using the Dong Bang acupuncture needle." (This is a safety claim based on past performance, not a study against 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.