(19 days)
Pyonex 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 Seirin PYONEX Acupuncture Needle is a sterile, single use only acupuncture needle. The Seirin PYONEX 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) summary for an acupuncture needle, not a study describing the performance of a novel AI device. Therefore, most of the requested information regarding AI device acceptance criteria, performance studies, sample sizes, expert ground truth, and MRMC studies is not applicable to this submission.
However, I can extract the relevant information from the provided text based on the nature of this medical device submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Device Type/Function | Intended to pierce the skin in the practice of acupuncture by qualified practitioners. | The Seirin PYONEX Acupuncture Needle is a sterile, single-use only acupuncture needle that meets general specifications and criteria for an acupuncture needle. |
| Sterility | Acupuncture needles currently marketed should be sterile. | The Seirin PYONEX Acupuncture Needle is described as sterile. |
| Single Use | Acupuncture needles currently marketed should be single use only. | The Seirin PYONEX Acupuncture Needle is described as single-use only. |
| Safety Record | No serious or life-threatening accidents involving acupuncture needles marketed prior to May 28, 1976 (the predicate device type). Newer needles offer greater safety. | No accidents or device failure claims have been reported as a result of using the Seirin PYONEX brand acupuncture needle since its import into the USA in 1983. |
| Equivalency | Equivalent to acupuncture needles in commercial distribution prior to May 28, 1976 and to other acupuncture needles currently sold through interstate commerce. | The Seirin PYONEX Acupuncture Needle is concluded to meet the criteria for 510(k) acceptance, and is equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance:
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Sample Size for Test Set: Not applicable. This submission relies on historical data, market comparisons, and the absence of adverse event reports, rather than a specific "test set" in the context of an AI device performance study. The statement "no accidents or device failure claims have been reported as a result of using the Seirin PYONEX brand acupuncture needle since its import into the USA in 1983" serves as post-market safety data.
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Data Provenance: The device was manufactured in Japan in 1978 and imported/sold in the USA since 1983. The data regarding lack of adverse events is retrospective, based on "no accidents or device failure claims" reported during its marketing in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no "test set" and thus no ground truth established by experts in a formal study setting for this needle. The safety and effectiveness are established through predicate device comparison and a lack of reported adverse events over a long period of marketing.
4. Adjudication method for the test set:
- Not applicable, as no formal test set with ground truth adjudication was conducted.
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:
- Not applicable. This is not an AI device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI device.
7. The type of ground truth used:
- The "ground truth" here is implied by historical safety data and market acceptance of similar devices. For the PYONEX needle specifically, the "ground truth" for its safety and effectiveness is primarily established by:
- Predicate device equivalence: Comparison to acupuncture needles in commercial distribution prior to May 28, 1976.
- Absence of reported adverse events: "no accidents or device failure claims have been reported as a result of using the Seirin PYONEX brand acupuncture needle" since 1983.
8. The sample size for the training set:
- Not applicable. This is not an AI device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI device.
§ 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.