(311 days)
Sterile with E.O.G. . 'Caution: Acupuncture needles are device intend to pierce the skin in the practice of acupuncture by qualified practitioners as determined by states'
Not Found
The provided document is a 510(k) clearance letter from the FDA for an Acupuncture Needle (K071524). It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this type of document does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for a diagnostic or AI-driven medical device.
The 510(k) pathway for a device like an acupuncture needle focuses on demonstrating substantial equivalence to a predicate device, often through evidence like:
- Physical/material specifications and comparisons.
- Sterilization methods.
- Biocompatibility testing (if applicable).
- Labeling.
- Performance testing related to its mechanical function (e.g., needle strength, sharpness, sterility maintenance).
There is no mention of a study involving expert readers, AI assistance, or complex performance metrics that would be typically found in a clearance for a diagnostic imaging device or an AI/ML medical device.
Therefore, I cannot fulfill the request using the provided input.
§ 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.