(303 days)
To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states.
ASP Type needles consists of a short "tack-like" solid stainless steel needle contained in a plastic injector to introduce the needle in the epidermis, to facilitate the delivery of acupuncture treatment. ASP needles are sterile devices for single use only. The "ASP Gold needle" is an "ASP needle" which has been gold plated (an intermediate laver of copper is added between stainless steel and gold). The ASP needles are offered in a single size.
The provided text is a 510(k) premarket notification for the SEDATELEC ASP Acupuncture Needles. It does not describe an acceptance criteria study or report device performance against specific criteria in the way typically expected for an AI/CADe device. Instead, it demonstrates substantial equivalence to a predicate device, which is a common regulatory pathway for medical devices.
Therefore, many of your requested points are not directly applicable or cannot be extracted from this document, as the focus is on demonstrating similarity to an already approved device rather than proving novel performance against predefined criteria through a clinical study.
Here's an analysis based on the provided document:
1. Table of acceptance criteria and the reported device performance
This document does not present acceptance criteria or reported device performance for the ASP Acupuncture Needles in terms of specific metrics like sensitivity, specificity, or accuracy. The demonstration of safety and effectiveness relies on substantial equivalence to a legally marketed predicate device (Seirin - S & Seirin - Pionex acupuncture needles).
Substantial Equivalence Comparison (Excerpted from the document):
| Equivalency Comparison Feature | SEDATELEC ASP & ASP Gold acupuncture needles | SEIRIN - S SEIRIN - PIONEX acupuncture needles |
|---|---|---|
| Device Type: | Tack | Tack |
| Intended use: | Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states | Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states |
| Invasive Length (mm) | 2.1mm | From 15 to 50mm |
| From 1.5 to 1.8 mm | ||
| Gauge (diameter in mm) | 0 to 0.7 mm | From 0.22 to 0.26mm |
| From 0.20 to 0.35mm | ||
| Needle Tip Shape | Taper | Taper |
| Needle shape | Harpoon shape | Stylet |
| Thumbtack shape | ||
| Biocompatibility | ASTM 430F surgical stainless steel (Standard specifications for stainless steel billet, bar, and wire for surgical instruments F899-84) | Same |
| Materials | needle: surgical stainless steel (+ a copper layer and a gold layer for ASP Gold) | needle : surgical stainless steel |
| handle : plastic | ||
| Sterilization Method | Gamma radiation at a validated dose level of 25kGv | Sterilized with Ethylene oxide gas (for predicate - note this is a difference but still accepted for substantial equivalence) |
The core "acceptance criteria" here is that the device is "substantially equivalent" to the predicate, meaning it is as safe and effective.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to a 510(k) submission based on substantial equivalence for a physical device like an acupuncture needle. There isn't a "test set" of data in the context of an AI/CADe algorithm. The evaluation is based on manufacturing processes, materials, intended use, and general device characteristics compared to a known safe and effective predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This type of expert review for ground truth is associated with AI/CADe performance studies.
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 not an AI/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/CADe device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this type of 510(k) submission, the "ground truth" for safety and effectiveness is established by the legally marketed predicate device. The fundamental premise is that if the new device is sufficiently similar in design, materials, and intended use to an existing device, it can be presumed to be equally safe and effective without requiring a full de novo approval process.
8. The sample size for the training set
Not applicable. This is not an AI/CADe device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/CADe device.
Summary based on the document:
The SEDATELEC ASP Acupuncture Needles were approved based on substantial equivalence to existing legally marketed acupuncture needles (Seirin - S & Seirin - Pionex). The FDA determined that the device is as safe and effective as the predicate device because it shares similar technological characteristics (materials, intended use, sterilization method (though different, it is validated), and basic design). There was no need for a clinical "acceptance criteria" study in the context of AI/CADe performance, as the device is a simple, physical medical instrument.
§ 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.