(94 days)
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
The Magi acupuncture needle is a sterile surgical stainless steel, single use only acupuncture needle. The Magi 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 a medical device (Magi Acupuncture Needle) seeking clearance from the FDA. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a study with performance metrics.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, expert ground truth, or MRMC studies.
Instead, the document asserts:
- Substantial Equivalence: The Magi acupuncture needles are "substantially equivalent" to other legally marketed acupuncture needles.
- Safety Record: Since 1992, "no accident or device failure claims have been reported as a result of using the Magi acupuncture needle."
- Intended Use: "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."
Without a performance study, I cannot fill out the requested table or specify details about test sets, ground truth establishment, or statistical analysis.
§ 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.