Search Results
Found 6 results
510(k) Data Aggregation
(272 days)
The device is 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, hair 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 gamma irradiation. The Acupuncture Needles are available in eleven diameters (0.14 to 0.50 mm), nine needle lengths (15-60mm), two stick lengths (20 and 30 mm), and nine tube lengths (30-145 mm).
Acupuncture Needles (K092240) - Acceptance Criteria and Performance Study
The K092240 submission concerns Acupuncture Needles manufactured by HaengLim SeoWon Medical Co. The primary study presented aims to demonstrate substantial equivalence to predicate devices rather than establishing novel safety and efficacy criteria through a clinical trial.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (K092240) |
|---|---|
| Surface Smoothness & Freedom from Visible Defects | Surfaces found to be smooth and free of visible defects at 200-300X magnification. |
| Pull-out Force | Quantified pull-out force fell within the average values reported for the predicate devices. |
| Elasticity Properties (No Permanent Deformation after Cantilever-Type Loading) | Returned to original shape after cantilever-type loading, showing no permanent deformation, similar to predicate devices. |
| Sterility | Sterilized with gamma irradiation (implied to meet relevant standards). |
| Material Composition | Manufactured from stainless steel (consistent with predicate devices). |
| Available Sizes (Diameters, Lengths) | Available in eleven diameters (0.14 to 0.50 mm), nine needle lengths (15-60mm), two stick lengths (20 and 30 mm), and nine tube lengths (30-145 mm) - implies offering a comparable range to predicate devices. |
| Intended Use | Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture (identical to predicate devices). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size in terms of a "test set" in the traditional sense of a clinical or in vivo study. The evaluation appears to be a bench-top comparison between the subject device and two predicate devices.
- Test Set: The "test set" consisted of the Acupuncture Needle (subject device) and two predicate devices (Dong Bang Acupuncture Needle, K972659 and C & G Acupuncture Needle, K043277).
- Data Provenance: The study was a retrospective bench-top comparison performed on the devices themselves. No details on the origin of the specific samples (e.g., country of origin for the tested devices) are provided, beyond the manufacturing location of the subject device (Korea) and the listed applicants of the predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The study does not involve human observers or interpretation of medical images, thus the concept of "experts" establishing ground truth for a test set is not applicable in the traditional sense. The "ground truth" for the mechanical and microscopic properties was based on direct measurement and observation by the individuals conducting the testing. Their qualifications are not specified, but it's presumed they were technicians or engineers competent in microscopy and mechanical testing.
4. Adjudication Method for the Test Set
No adjudication method was used, as the study involved direct physical and mechanical testing rather than human interpretation requiring consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted. This device is an acupuncture needle, and the study focuses on its physical and mechanical properties compared to legally marketed predicate devices, not on the improvement of human readers with AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The device is a physical medical instrument (acupuncture needle), not an algorithm or AI-powered system.
7. Type of Ground Truth Used
The ground truth used was based on direct physical and mechanical measurements and microscopic observations. This includes:
- Visual assessment under magnification for surface defects.
- Quantitative measurement of pull-out force.
- Qualitative assessment of elasticity (return to original shape after loading).
8. Sample Size for the Training Set
Not applicable. There was no "training set" as this was a physical device comparison study, not a machine learning or AI context.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there was no training set, there was no ground truth for a training set to be established.
Ask a specific question about this device
(53 days)
To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the States.
Marknew Products Acupuncture Needles
I apologize, but the provided text is a 510(k) clearance letter from the FDA for acupuncture needles. It does not contain any information about acceptance criteria for a device, a study proving device performance, or any of the specific details requested in your prompt (like sample sizes, ground truth establishment, or expert qualifications).
Therefore, I cannot fulfill your request based on the given input.
Ask a specific question about this device
(195 days)
The Singer Acupuncture Needle is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states .
Singer Acupuncture Needle
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Singer Acupuncture Needle." This document primarily addresses the substantial equivalence of the device to legally marketed predicate devices, allowing it to be marketed.
Crucially, this type of regulatory document does not typically include information about specific acceptance criteria and detailed study results as requested in your prompt. 510(k) clearances are based on demonstrating substantial equivalence, not necessarily on new clinical performance studies involving a pre-defined set of acceptance criteria. While the manufacturer would have performed various tests to ensure safety and performance, the details of those tests, their acceptance criteria, and specific study designs (like sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance) are not part of this public FDA clearance letter.
Therefore, I cannot extract the requested information from the provided text. The document confirms the device is an acupuncture needle, is prescription-use only, and is intended to pierce the skin in the practice of acupuncture by qualified practitioners. It does not contain any of the detailed study information you've asked for.
Ask a specific question about this device
(176 days)
The acupuncture needles devices licensed are used by practitioners which are intended to pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states.
Not Found
This document is a 510(k) clearance letter from the FDA for Acupuncture Needles, allowing them to be marketed based on substantial equivalence to existing devices. As such, it does not contain the detailed information about acceptance criteria and clinical study results typically found in a Premarket Approval (PMA) application or a more extensive 510(k) submission summary.
Therefore, I cannot provide the requested information. This document primarily focuses on regulatory clearance based on substantial equivalence, rather than a performance study demonstrating acceptance criteria.
Ask a specific question about this device
(70 days)
Ask a specific question about this device
(181 days)
Ask a specific question about this device
Page 1 of 1