(62 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 Soft Needle - is a sterile, silicon coated, single use only acupuncture needle. The design, material used, sterlity 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 text describes a 510(k) premarket notification for the "KHT Soft Needle" acupuncture needle, seeking clearance by demonstrating substantial equivalence to a legally marketed predicate device. This is primarily a regulatory submission, not a study reporting on the performance of a device against pre-defined acceptance criteria in the way a clinical or technical performance study would.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this type of document for this particular product.
Here's an attempt to answer the questions based solely on the provided text, indicating where information is not available or not applicable for this kind of submission:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. The performance is assessed against the design, materials, sterilization, and biocompatibility of the predicate. Formal numerical acceptance criteria (e.g., minimum sensitivity/specificity) for a diagnostic device or specific measured performance for a therapeutic device are typically not explicitly stated and measured in this type of document for a Class II acupuncture needle.
| Acceptance Criteria (Implicit for 510(k) Substantial Equivalence) | Reported Device Performance (as claimed by applicant) |
|---|---|
| Intended Use: "To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States." | Same as predicate (implied, as it's an acupuncture needle) |
| Sterile: Single-use | "sterile, silicon coated, single use only acupuncture needle" |
| Material/Design: Meets general specifications and criteria for an 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" |
| Biocompatibility: Safe for use in humans with skin penetration | "biocompatibility... meet the general specifications and criteria" |
| Safety Record: No serious or life-threatening accidents when used appropriately | Predicate devices have a history of safe use ("not aware of any serious or life threatening accidents involving acupuncture needles" for 30+ years) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. This document does not describe a clinical study with a test set where device performance metrics are calculated based on patient data. Substantial equivalence is primarily demonstrated through comparison of technical characteristics, intended use, and materials to a predicate device.
- Data Provenance: Not applicable for a typical performance study. The 510(k) relies on the established safety and effectiveness of a predicate device already marketed in the US.
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)
- Number of Experts: Not applicable. No "ground truth" was established in a clinical sense for a test set, as this is a regulatory submission for a simple medical device, not a diagnostic or complex therapeutic device requiring such evaluation.
- Qualifications of Experts: Not applicable. No such expert panel was used to establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. There was no test set requiring adjudication in the context of this 510(k) submission.
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
- MRMC Comparative Effectiveness Study: No. This is an acupuncture needle, not an AI-powered diagnostic or therapeutic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This product is an acupuncture needle, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable in the context of a performance study. The "ground truth" for a 510(k) of this nature is essentially the established safety and effectiveness of the legally marketed predicate device (the Seirin Brand Acupuncture Needle, 510(k) Document Number: K963769, and pre-amendments devices) through their history of use and regulatory clearance.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. No training set was used.
§ 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.