(42 days)
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) Notification - the KHT Seoam Needle - is a sterile, single use only hand acupuncture needle. The design, material used, sterility and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture.
The provided 510(k) summary for the KHT Seoam Needle does not contain the detailed study information typically associated with acceptance criteria tables, sample sizes, expert involvement, or multi-reader multi-case studies as requested in the prompt. This submission relies on substantial equivalence to a predicate device rather than presenting a performance study with specific quantitative acceptance criteria.
Therefore, many of the requested fields cannot be filled based on the provided text.
Here's a breakdown of what can be answered and what cannot:
1. A table of acceptance criteria and the reported device performance
The submission states that the device "meet the general specifications and criteria for a single-use acupuncture needle and is effective for the practice of acupuncture." However, it does not provide specific, quantitative acceptance criteria (e.g., tensile strength, penetration force, sterility pass rates) or detailed performance data against such criteria. The primary "performance" stated is that it is "effective for the practice of acupuncture," which is a general claim rather than a measured performance metric.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided. The submission focuses on design, material, sterility, and biocompatibility, but no specific test set sample sizes or data provenance for performance testing are mentioned.
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. There's no indication of a test set requiring expert ground truth establishment in the context of this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 a medical device (acupuncture needle), not an AI-assisted diagnostic tool.
6. 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.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the typical sense of diagnostic ground truth. The "ground truth" for an acupuncture needle would pertain to its physical and functional properties (e.g., sterility, biocompatibility, sharpness, break resistance for effective and safe use).
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable.
Summary based on the provided text:
The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, particularly in terms of design, materials, sterility, and biocompatibility, rather than presenting a detailed performance study against specific, quantitative acceptance criteria.
KHT Seoam Needle Substantial Equivalence Claim:
- Legally Marketed Predicate Device: CW-Disposable Acupuncture Needle (510(k) Document Number: K962419) and acupuncture needles in commercial distribution prior to May 28, 1976.
- Key Equivalence Claims:
- Sterile
- Single-use only
- Hand acupuncture needle
- Design, material used, sterility, and biocompatibility meet general specifications and criteria for a single-use acupuncture needle.
- Effective for the practice of acupuncture.
The FDA's letter confirms that the device is "substantially equivalent" to predicate devices for the stated indications for use, without requiring explicit, quantitative performance data beyond the general claims of compliance with specifications and effectiveness for its intended purpose.
§ 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.