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510(k) Data Aggregation
(170 days)
WOOJEON ACUPUNCTURE NEEDLES is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states
The our needles are sterile 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 78 models as per diameters (0.16 to 0.40 mm) and 78 needle tube models as per lengths (8-60mm)
The "WOOJEON ACUPUNCTURE NEEDLE" 510(k) submission [K111392] provides information about the device's technical characteristics and claims of substantial equivalence but does not describe a study that establishes acceptance criteria or proves the device meets specific performance thresholds in a clinical or standalone evaluation.
Instead, the submission relies on demonstrating substantial equivalence to a predicate device (ASIA-MED Single use, Acupuncture Needle, K052085) based on technical characteristics and intended use.
Here's an analysis of the information provided, addressing your specific points where applicable, and highlighting what is not present in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Microscopic Examination (Surface Defects) | "The surfaces of the subject and predicate devices were found to be smooth and free of visible defects at 200-300X magnification." (Implies an unstated acceptance criterion of "smooth and free of visible defects," which the device met.) |
| Pull-out Force | "Also, the pull-out force of the Acupuncture Needle was quantified and fell within the average values reported for the predicate devices." (Implies an unstated acceptance criterion related to "average values of predicate devices," which the device met.) |
| Elasticity Properties | "Finally, the elasticity properties of the subject device were found to be substantially equivalent to the predicate devices." (Implies an unstated acceptance criterion of "substantial equivalence to predicate devices," which the device met.) |
Note: The document does not define specific numerical acceptance criteria (e.g., "pull-out force greater than X Newtons") but rather compares the device's performance to that of the predicate device or general observations.
2. Sample Size Used for the Test Set and Data Provenance
The document does not report a specific "test set" in the context of a clinical performance study. The listed evaluations (microscopic, pull-out, elasticity) are likely laboratory-based tests on samples of the manufactured needles. The sample size for these manufacturing tests is not specified.
Data provenance (country of origin, retrospective/prospective) is not applicable as there is no clinical study described. The manufacturer is based in South Korea, so the device manufacturing and testing would presumably be conducted there.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. The described evaluations are technical/mechanical tests (microscopic, pull-out, elasticity) performed on the device itself, not clinical assessments requiring expert ground truth for interpretation of patient data.
4. Adjudication Method for the Test Set
Not Applicable. There is no clinical test set or subjective assessment requiring an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission does not describe any study involving human readers or assessing improvement with AI assistance (as it is a physical medical device, not an AI-enabled diagnostic tool).
6. If a Standalone Study Was Done
The "studies" mentioned are laboratory tests of the device's physical properties:
- Microscopic examination of surfaces (smoothness and defects)
- Quantification of pull-out force
- Evaluation of elasticity properties
These are standalone technical evaluations of the device's characteristics against its predicate, but they are not a clinical standalone performance study in the typical sense (e.g., evaluating diagnostic accuracy or clinical outcomes). The document states these tests were performed to establish substantial equivalence.
7. The Type of Ground Truth Used
For the technical characteristics evaluated:
- Microscopic Examination: Ground truth is visually determined by inspection against a standard of "smooth and free of visible defects."
- Pull-out Force: Ground truth is the quantitative measurement of force, compared against the "average values reported for the predicate devices."
- Elasticity Properties: Ground truth is the measured elastic behavior, compared for "substantial equivalence" to the predicate.
These are engineering/material property ground truths derived from direct measurement and comparison, not clinical outcomes, pathology, or expert consensus on patient data.
8. The Sample Size for the Training Set
Not Applicable. This is a physical medical device. There is no AI model or "training set" in the context of machine learning. The manufacturing process of acupuncture needles is the "training" for consistent quality, not data training.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set as understood in AI/machine learning, this question does not apply.
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(90 days)
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.
Hansol Acupuncture Needle consists of components commonly found on Single use, Acupuncture Needle. The Hansol acupuncture needle is a sterile surgical stainless steel, single use only acupuncture needle. The Hansol acupuncture needle meets the general specification and criteria for an acupuncture needle and is effective for the practice of acupuncture.
The provided text describes the 510(k) summary for the Hansol Acupuncture Needle, which is a Class II medical device. The summary focuses on establishing substantial equivalence to a predicate device (ASIA-MED Single use, Acupuncture Needle, K052085) rather than presenting a performance study with detailed acceptance criteria and reported device performance metrics like sensitivity, specificity, or accuracy for an AI/algorithm-based device.
Therefore, many of the requested sections related to AI/algorithm performance and ground truth establishment cannot be extracted from this document, as it pertains to a physical medical device (an acupuncture needle) and its safety and effectiveness through bench testing, not an AI or software-as-a-medical-device (SaMD).
Here's an attempt to answer the questions based only on the provided text, highlighting where information is not available or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Device must be biocompatible. | Bench tests performed demonstrating biocompatibility. |
| Sterility: Device must be sterile. | Sterility testing performed. |
| Substantial Equivalence: Device must be as safe, as effective, and perform in a substantially equivalent manner to the predicate device (ASIA-MED Single use, Acupuncture Needle, K052085). | The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device. |
| General Specification & Criteria: Meets general specifications and criteria for an acupuncture needle. | Device meets the general specification and criteria for an acupuncture needle and is effective for the practice of acupuncture. |
2. Sample size used for the test set and the data provenance
- Not Applicable: This document describes a physical medical device (acupuncture needle) and its bench testing to establish substantial equivalence. It does not involve a "test set" of data in the context of an AI/algorithm study. The testing performed involved biocompatibility and sterility. The sample sizes for these bench tests are not provided in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: Ground truth establishment by experts is not relevant for the type of device and testing described (physical acupuncture needle, bench testing for biocompatibility and sterility).
4. Adjudication method for the test set
- Not Applicable: Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical evaluations involving human interpretation, especially for AI/algorithm-based devices. This is not relevant for the bench testing of a physical acupuncture needle.
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
- No: No MRMC study was done. This type of study is relevant for AI/algorithm-assisted diagnostic or interpretive devices, not for a physical acupuncture needle.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: This is a physical device, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. The type of ground truth used
- Not Applicable/Indirect: For a physical device like an acupuncture needle, "ground truth" is typically defined by established engineering standards, material specifications, and biological testing protocols for biocompatibility and sterility. The "ground truth" for the performance claims would be the results of the bench tests against these defined standards and the performance of the predicate device. The document states "Bench tests were performed. Bench testing included biocompatibility, sterility testing." The results of these tests (e.g., passing sterility tests, meeting biocompatibility standards) form the basis of the performance claims.
8. The sample size for the training set
- Not Applicable: There is no "training set" as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established
- Not Applicable: There is no "training set" or corresponding ground truth establishment described for this device.
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