(56 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) application - the KHT Sooji Needle - is a sterilized, 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 document is a 510(k) summary for the KHT Sooji Needle, a hand acupuncture needle. It focuses on demonstrating substantial equivalence to pre-amendment devices and currently marketed single-use acupuncture needles rather than reporting performance against specific acceptance criteria from a comprehensive study to prove detailed device performance.
Therefore, the requested information elements (1-9) about acceptance criteria, study details, and ground truth establishment are largely not applicable or extractable from this type of regulatory submission. This document highlights that the device "meets the general specifications and criteria for a single use acupuncture needle and is effective for the practice of acupuncture," but it does not present a formal study with detailed acceptance criteria and performance metrics in the format requested.
However, I can extract the following information that is available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied from 510(k) Summary) | Reported Device Performance |
|---|---|
| Sterilization | Sterilized |
| Single-use design | Single-use only |
| Biocompatibility | Biocompatibility meets general specifications |
| Material used | Material meets general specifications |
| Effectiveness for acupuncture practice | Effective for the practice of acupuncture |
| Equivalence to pre-amendment devices | Equivalent to acupuncture needles in commercial distribution prior to May 28, 1976 |
| Equivalence to currently marketed single-use acupuncture needles | Equivalent to other single-use acupuncture needles currently sold through interstate commerce |
Comment: The document doesn't define quantitative 'acceptance criteria' in the sense of specific thresholds for a study (e.g., minimum sensitivity, specificity, accuracy). Instead, it asserts that its design, material, sterility, and biocompatibility "meet the general specifications and criteria" for the device type and that it is "effective for the practice of acupuncture." The primary 'acceptance criterion' for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device.
2. Sample size used for the test set and the data provenance
- Not Applicable. The 510(k) summary provided does not describe a performance study with a distinct test set, sample size, or data provenance. The assessment is based on design, materials, and comparison to predicate devices, not on a clinical or performance trial with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No test set or ground truth establishment by experts is described in this regulatory submission.
4. Adjudication method for the test set
- Not Applicable. No test set or adjudication method is described.
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 device is a physical medical device (acupuncture needle), not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is irrelevant.
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 consensus, pathology, outcomes data, etc.)
- Not Applicable. No formal ground truth for performance evaluation is described. The "ground truth" for the 510(k) process is the established safety and effectiveness of the predicate devices to which substantial equivalence is claimed.
8. The sample size for the training set
- Not Applicable. The 510(k) summary does not describe a machine learning model or a training set.
9. How the ground truth for the training set was established
- Not Applicable. The 510(k) summary does not describe a machine learning model or a training set with established ground truth.
In summary, this 510(k) document is a regulatory submission demonstrating substantial equivalence rather than a clinical or performance study that would typically include the detailed information requested for device performance assessment.
§ 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.