(115 days)
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
Vinco Brand Acupuncture Needle
Here's an analysis of the provided text regarding the Vinco Brand Acupuncture Needle, focusing on the requested information:
The provided document is a 510(k) clearance letter from the FDA for a medical device: the Vinco Brand Acupuncture Needle. This type of document primarily confirms that a new device is "substantially equivalent" to a legally marketed predicate device, rather than detailing a comprehensive scientific study evaluating its performance against specific acceptance criteria.
Therefore, many of the requested points regarding acceptance criteria and a study proving device performance cannot be found within this document. The FDA clearance is based on a demonstration of equivalence in design, materials, and intended use to a pre-existing device, not necessarily extensive new clinical trial data.
Based on the provided text, here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance
- Not explicitly available. The document does not list specific performance criteria (e.g., tensile strength, sharpness, sterility levels) or corresponding test results for the Vinco Brand Acupuncture Needle. The clearance is based on substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not available. The document does not describe any specific "test set" or studies of this nature. Given it's a 510(k) for an acupuncture needle, any testing would likely be bench testing related to safety and manufacturing, not clinical trials with human subjects in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable/available. This refers to clinical studies where expert consensus defines ground truth, which is not described here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/available. This refers to clinical studies where expert consensus defines ground truth, which is not described here.
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 type of study is relevant for AI-powered diagnostic tools, not for an acupuncture needle.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is for AI algorithms, not for a physical medical device like an acupuncture needle.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/available. Ground truth is a concept for diagnostic or predictive models; for a physical device like this, compliance with manufacturing standards and safety profiles are key.
8. The sample size for the training set
- Not applicable. This refers to AI algorithms, not a physical medical device.
9. How the ground truth for the training set was established
- Not applicable. This refers to AI algorithms, not a physical medical device.
Summary from the document:
- Device Name: Vinco Brand Acupuncture Needle
- Regulation Number: 880.5580
- Regulation Name: Acupuncture Needle
- Regulatory Class: II
- Product Code: MQX
- Indication for Use: To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
- Basis for Clearance: Substantial equivalence to legally marketed predicate devices, meaning it has essentially the same intended use, technological characteristics, and safety/effectiveness profile as a device already on the market. The document implies that the device meets the general controls provisions of the Act (e.g., annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration) and any additional Class II special controls, though these specific controls are not detailed in this letter.
§ 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.