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510(k) Data Aggregation
(334 days)
Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles
Our acupuncture needles are devices used by licensed practitioners and are intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
The acupuncture needles are sterile, thin needles which are inserted into specific points on the skin called "acupuncture points." The Acupuncture Needles are manufactured from stainless steel and sterilized with ethylene oxide gas. Acupuncture is the stimulation of specific acupuncture points along the skin of the body involving various methods such as penetration by thin needles. The skin is sterilized, such as with alcohol, and the needles are inserted, frequently with a plastic guide tube for the user. Needles may be manipulated in various ways including spinning, flicking, or moving up and down relative to the skin. The Acuzone Acupuncture Needles and KSC DB Plus Acupuncture Needles are made of surgical stainless steel, a handle consisting of a flexible coiled copper handle with nickel plated for protection, or a surgical stainless steel or aluminum tube handle and may be provided with a plastic guide tube. (10pcs/pack, 1000pcs/box). Acuzone press tack needles (with micropore tape) are made with surgical stainless steel (10pcs/ pack, 100pcs/box). AcuZone Intradermal Needles are made with surgical stainless steel (5pcs/pack, 100pcs/box). Press tack and intradermal needles have same purpose for ear acupuncture point. The Acupuncture needles are available in nine diameters (0.12 ~ 0.35mm), five needle lengths (15 ~ 60mm), and tube lengths (30mm, 45mm, 55mm, 65mm and 75mm). Acuzone press tack needle is available in one diameter (0.20mm x 2mm x length (1mm). AcuZone Intradermal Needles is available in one diameter (0.12mm), one length (5mm).
This document is a 510(k) Summary for AcuZone Acupuncture Needles, KSC DB Plus Acupuncture Needles, AcuZone Press Tack Needles, and AcuZone Intradermal Needles. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable way for the performance tests. Instead, it refers to the outcomes of tests as meeting "requirements of those standards" or being "substantially equivalent" to predicate devices. The performance data presented focuses on comparisons with predicate devices and compliance with relevant ISO standards.
| Criterion Type | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Visual | Smooth and free of visible defects (at 100X or higher magnification) | Surfaces of subject device (AcuZone and KSC DB Plus Acupuncture Needles) found to be smooth and free of visible defects at 100X or higher magnification. |
| Pull-out Force | Fell within average values reported for predicate devices | Pull-out force of Acupuncture Needle was quantified and fell within the average values reported for the predicate devices. |
| Elasticity | Returned to original shape showing no permanent deformation | Elasticity properties of the subject device were found to be substantially equivalent to the two predicate devices, as after cantilever-type loading all devices returned to their original shape showing no permanent deformation. |
| Biocompatibility | Met requirements of applicable ISO 10993 series | Biocompatibility testing based on applicable elements of ISO 10993 series (including Material Mediated Pyrogen Testing using ISO 10993-11 and EO and ECH Residuals Testing in accordance with ISO 10993-7) was conducted and device met requirements. |
| Sterilization | Met requirements of relevant validation/testing | EO Sterilization Validation, Sterility Testing, Bacterial Endotoxin Testing, Validation, and Long-Term Stability Testing were performed, indicating compliance. (The document doesn't specify if specific standards were met, but "Validation" implies meeting predefined acceptance criteria for these processes). |
| Dimensional Conformance | Conformance to specified dimensions | Dimensional conformance evaluation was conducted. (Assumed to be successful, as it contributes to the overall conclusion of substantial equivalence). |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not provide specific sample sizes for the performance tests (visual inspections, pull-out force, elasticity, biocompatibility, sterilization, dimensional conformance). It generally refers to "the Acupuncture Needle" or "all devices" when discussing testing.
Data Provenance: The data appears to be prospective as it describes testing conducted specifically for this 510(k) submission. The country of origin of the data is not explicitly stated, but the testing was conducted to support a submission by a U.S. corporation (K. S. Choi Corporation in Los Angeles, California) to the U.S. FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The testing described (mechanical, visual, biocompatibility, sterilization) would typically be performed by laboratory technicians or engineers following established protocols, not by medical experts establishing "ground truth" in the clinical sense.
4. Adjudication Method for the Test Set
This information is not applicable to the type of testing described (physical and chemical properties, sterilization) for acupuncture needles. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image interpretation where human expert consensus is required for complex decisions.
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
An MRMC comparative effectiveness study was not done. This document describes the substantial equivalence of an acupuncture needle, which is a physical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an acupuncture needle, a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established through physical and chemical characterization, and compliance with recognized standards. This includes:
- Microscopic examination for surface quality.
- Mechanical testing (pull-out force, elasticity) against quantifiable parameters.
- Biocompatibility testing against ISO 10993 series standards.
- Sterilization validation against established protocols (e.g., for EO sterilization and residuals).
- Dimensional conformance to specifications.
- Comparison to the performance of legally marketed predicate devices.
8. The Sample Size for the Training Set
This is not applicable. The device is an acupuncture needle, not a machine-learning algorithm; therefore, there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set mentioned or implied for an acupuncture needle.
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