(43 days)
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
The Holy Dragon Brand Acupuncture Needles are sterile disposable, surgical stainless steel with a spiral wound silver or copper handle that is mechanically attached. The needles are supplied individually blister sealed packaged with polypropylene insertion tubes and medical grade paper. They are sold in paper carton boxes in quantities of either 100 or 500 needles per box. Statements "For single use only," "Federal law restricts this device to sale by or on the order of qualified practitioners of acupuncture as determined by the States," "Pyrogen Free," and "made in China" are shown in box labeling.
The provided document is a 510(k) premarket notification for acupuncture needles. These types of submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria in the manner requested for an AI/ML device.
However, I can extract what information is available and highlight what is missing based on your request.
Analysis of the document for acceptance criteria and study information:
The document primarily focuses on establishing "substantial equivalence" of the Holy Dragon Brand Acupuncture Needles to previously marketed devices. This regulatory pathway does not typically require the rigorous performance studies and statistical analysis associated with novel device approvals or AI/ML device evaluations.
The only "test results" mentioned pertain to physical characteristics of the needles:
- Acupuncture Needle Buckling/Stiffness Test Results: This section lists a specification for "0.30* 25mm" and "Batch number 002/05" with a batch size of "150,000 pieces." The test basis is "GB/T 4342 -91 (Chinese National Standard)". No actual buckling/stiffness results are provided, only the specification. This appears to be a header for a test rather than the results themselves.
- Inspection/Test records For The hardness Of Body part of the needles (at HV 0.2kg): This section lists a series of 8 hardness values: "468, 472, 475, 470, 468, 465, 468, 470." No acceptance criteria (min/max hardness) are provided for these values.
Given the nature of the device (acupuncture needles) and the 510(k) submission type, the request for information typically associated with AI/ML device studies (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies) is not applicable here.
Based on the provided document, here's the information, with many sections marked as "Not Applicable" or "Not Provided" due to the nature of the submission and device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|
| Acupuncture Needle Buckling/Stiffness: | |
| Specification: 0.30* 25mm (for a specific needle type) | Actual buckling/stiffness test results are not provided; only the specification is listed. |
| Hardness of Body Part of needles (at HV 0.2kg): | |
| No explicit acceptance criteria (e.g., min/max range) are provided. | 468, 472, 475, 470, 468, 465, 468, 470 (for 8 samples) |
Note: The document explicitly states: "Substantial equivalence is not based on an assessment of performance data." This indicates that the 510(k) approval was based on comparison to predicate devices, not extensive performance studies against pre-defined acceptance criteria for clinical efficacy or sophisticated functional performance. The above table reflects the only quantitative test data presented.
2. Sample size used for the test set and the data provenance
- Sample Size for Hardness Test: 8 needles (for the hardness test).
- Data Provenance: The tests were conducted by the manufacturer, Wujiang City Hua Xin Medical Appliance Co., Ltd., which is located in Jiangsu Province, P. R. of China. The document indicates tests were performed against a Chinese National Standard (GB/T 4342 -91). The study is prospective in the sense that these tests were likely performed on a recent manufacturing batch for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a physical medical instrument (acupuncture needles), not an AI/ML diagnostic or predictive system requiring expert-established ground truth for its performance evaluation in the requested sense. Its performance is assessed through physical property tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this is about physical properties, not diagnostic interpretations.
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. This is not an AI/ML device and therefore no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. For the physical tests, the "ground truth" would be the measured physical properties themselves, compared against relevant material science or engineering standards, rather than clinical outcomes or expert consensus.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.
§ 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.