(136 days)
The acupuncture needles are devices used by licensed practitioners which are intended to pierce the ski in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Acupuncture needles is defined as a device intended to pierce the skin in the practice of acupuncture by qualified practitioner of acupuncture as determined by the States. The subject of this 510(k) application - the Natural Brand acupuncture needles - is sterile, single use acupuncture needles.
This document describes the premarket notification (510(k)) for the Natural Brand acupuncture needles. However, it does not contain a study with acceptance criteria and reported device performance in the way a typical medical device validation study for a new, innovative device would.
The core of this 510(k) submission is based on substantial equivalence to devices already on the market prior to May 28, 1976, and to other currently marketed acupuncture needles. Therefore, the "acceptance criteria" and "device performance" are primarily focused on meeting the definition of an acupuncture needle and demonstrating a safe history of use, rather than detailed performance metrics from a formal study.
Here's a breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material/Design: Sterile, single-use acupuncture needle | The Natural Brand acupuncture needle is sterile, single-use, and meets general specifications and criteria for an acupuncture needle. |
| Intended Use: Device intended to pierce the skin in the practice of acupuncture by qualified practitioners. | The Natural Brand acupuncture needle is effective for the practice of acupuncture. |
| Safety: No serious or life-threatening accidents. | No accidents or device failure claims reported since 1985 (when sold under investigational use). Not aware of serious or life-threatening accidents with acupuncture needles used for over 30 years. |
| Substantial Equivalence: Equivalent to acupuncture needles in commercial distribution prior to May 28, 1976, and to other currently marketed acupuncture needles. | Claimed as met. The FDA letter confirms the device is substantially equivalent to legally marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of a performance study. The "test set" here would refer to the historical use of the device and other similar devices.
- Data Provenance:
- Natural Brand: The device has been imported and sold in the USA since 1985 under "investigational use" labeling. Records of no reported accidents or device failure claims since 1985 were used. This is retrospective data from a specific device's commercial history.
- General Acupuncture Needles: General knowledge and historical data of acupuncture needles being used for over 30 years in the US without serious incidents. This is also retrospective, broad historical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as there was no formal "test set" with a ground truth established by experts in the context of a performance study. The "ground truth" here is the established safe and effective use of acupuncture needles generally, and the lack of reported issues with the Natural Brand specifically.
4. Adjudication Method for the Test Set
- Not applicable, as there was no formal "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No, an MRMC comparative effectiveness study was not done. This device is a simple medical instrument (acupuncture needle), not an AI-powered diagnostic or therapeutic system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, this is not applicable. The device is a physical instrument, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" in this context is based on:
- Historical Safety Data: Lack of reported accidents or device failures for the Natural Brand needle over many years of use.
- General Acceptance/Experience: Long-standing, safe use of acupuncture needles in the US for over 30 years.
- Functional Definition: The device meets the generally accepted definition and function of an acupuncture needle (to pierce the skin for acupuncture).
8. The Sample Size for the Training Set
- Not applicable, as this is not an AI/machine learning device. The "training" for the substantial equivalence argument comes from the historical use and established safety of predicate devices.
9. How the Ground Truth for the Training Set Was Established
- Not applicable as there is no "training set" in the machine learning sense. The "ground truth" for the substantial equivalence argument relies on:
- The regulatory classification and established safety profile of acupuncture needles as a class of devices.
- The lack of adverse events reported for the specific device (Natural Brand) during its prior distribution under investigational labeling.
- The general consensus in the medical community about the safe practice of acupuncture with appropriately manufactured needles.
§ 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.