(8 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 Ito acupuncture needle - is a sterile, single use only acupuncture needle. The Ito acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
The provided text describes a 510(k) Pre-Market Notification for an acupuncture needle, not a study that proves a device meets specific acceptance criteria in the context of AI/ML or a detailed clinical trial. The document is an application for market clearance based on substantial equivalence to predicate devices. Therefore, many of the requested elements (like sample size for test sets, number of experts for ground truth, MRMC studies, training set details, etc.) are not applicable or not present in this type of regulatory submission.
However, I can extract what is available and explain why other sections are not present:
Acceptance Criteria and Device Performance (as inferred from a 510(k) submission):
| Acceptance Criteria (Inferred for 510(k) Equivalence) | Reported Device Performance (Ito Acupuncture Needle) |
|---|---|
| Sterile | Sterile, single use only |
| Single Use Only | Sterile, single use only |
| Meets general specifications and criteria for an acupuncture needle | Meets general specifications and criteria for an acupuncture needle |
| Effective for the practice of acupuncture | Effective for the practice of acupuncture |
| No serious or life-threatening accidents reported | No accidents or device failure claims reported since 1984 |
| Equivalent to pre-amendment devices (prior to May 28, 1976) | Equivalent to acupuncture needles in commercial distribution prior to May 28, 1976 |
| Equivalent to currently marketed devices (1996) | Equivalent to other acupuncture needles currently being sold through interstate commerce |
Explanation for Missing Information based on 510(k) Submission Type:
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Sample size used for the test set and the data provenance: Not applicable. A 510(k) submission for an acupuncture needle like this generally relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a separate clinical trial with a "test set" in the context of an AI/ML device. The "data provenance" mentioned is that the device has been in use in Japan since 1984 and in the USA since 1984 under investigational use.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this type of device is its historical safe and effective use, and its equivalence to other devices. There is no mention of experts establishing ground truth for a test set in this document.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no "test set" in the sense of a dataset requiring expert adjudication for performance evaluation.
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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 device is an acupuncture needle, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" implicitly used for this 510(k) submission is the historical performance and established safety/effectiveness of predicate acupuncture needles, and the absence of reported accidents or device failures for the Ito brand over a period of 12 years (1984-1996).
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The sample size for the training set: Not applicable. There is no concept of a "training set" for a physical medical device like an acupuncture needle in this context.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a conventional medical device (acupuncture needle) and does not contain the type of AI/ML or clinical study information requested.
§ 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.