(33 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 DBC acupuncture needle - is a sterile, single use only acupuncture needle. The DBC acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
This document is a 510(k) Pre-Market Notification for an acupuncture needle. It does not contain the type of detailed performance criteria and study results typically found for devices that involve AI, image analysis, or complex diagnostic functions.
Here's why the requested information cannot be extracted from the provided text:
- Device Type: Acupuncture needles are relatively simple medical devices. Their primary function is to pierce the skin for acupuncture. The "performance" in this context is about sterility, single-use, and general functionality, not diagnostic accuracy or expert interpretation.
- Lack of AI/Algorithm: The document makes no mention of AI, machine learning, image analysis, or any algorithm. Therefore, concepts like acceptance criteria for AI performance (sensitivity, specificity, AUC), ground truth establishment by experts, training/test sets, or MRMC studies are not applicable.
- Focus of the 510(k): This 510(k) is focused on demonstrating substantial equivalence to predicate devices already on the market. The criteria for acceptance are primarily related to safety (sterility, single-use) and general functionality, not on analytical or clinical performance metrics that would require expert-adjudicated studies.
Therefore, I cannot fulfill your request for the specific points because the provided document does not contain information about:
- A table of acceptance criteria and reported device performance related to AI/diagnostic accuracy.
- Sample sizes for test sets, data provenance, number of experts, or adjudication methods for diagnostic performance.
- Multi-reader, multi-case comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth (expert consensus, pathology, etc.) related to diagnostic accuracy.
- Sample size for a training set or how ground truth was established for a training set.
The document's "acceptance criteria" are implied to be meeting the safety and functionality standards for acupuncture needles and demonstrating equivalence to existing devices. The "study" proving this is essentially the information provided in the 510(k) application, highlighting its sterility, single-use nature, and lack of adverse event reports over years of use.
§ 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.