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The AIK Sterile Acupuncture Needles for Single Use 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 manufactured from stainless steel and sterilized with ethylene oxide gas. Acupuncture needle is made up of needle handle and needle body. The body of needle uses 304 stainless steel wire (06Cr19Ni10). The handle is a body coil with stainless steel wire, the spiral loop of which is arranged symmetrically without gaps. The device can only be used by qualified practitioners of acupunctures. Qualified practitioners should already be knowledgeable on how to use the acupuncture needle and when not to use acupuncture in certain patient populations and medical conditions. Handle of acupuncture needle is a plain handle. Types of acupuncture needle (sterile acupuncture needle for single use) are: acupuncture needle without a guide tube and acupuncture needle with a guide tube.

Here's a breakdown of the acceptance criteria and study information for the AIK Sterile Acupuncture Needles for Single Use, based on the provided document:

This document describes a 510(k) premarket notification for a medical device called "AIK Sterile Acupuncture Needles for Single Use." This is not a study assessing the performance of an AI algorithm, but rather a submission for a traditional medical device (acupuncture needles) demonstrating substantial equivalence to a legally marketed predicate device. Therefore, many of the requested categories related to AI performance, ground truth establishment, and expert involvement are not applicable or directly addressed in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance data in a quantitative manner for most tests. Instead, it states that the device "meet[s] the requirements of its pre-defined acceptance criteria." For functional performance tests, it lists the test and a qualitative outcome indicating compliance.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific "sample size" for each test. Non-clinical testing was conducted to evaluate performance. The provenance of the data is from CHANGCHUN AIK MEDICAL DEVICES CO., LTD in Jilin Province, China, as part of their submission to the FDA. The tests are non-clinical, likely laboratory-based, and therefore not strictly "retrospective" or "prospective" in the sense of patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This is not applicable. The device is an acupuncture needle, and the "ground truth" for its performance is established by objective engineering and biocompatibility standards (e.g., ISO 17218, ISO 10993-1, ISO 11135, ISO 11607), not by expert human interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable, as "adjudication" typically refers to resolving discrepancies between human readers or between human readers and an AI system. The tests performed are objective, laboratory-based evaluations against pre-defined engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This study is a 510(k) premarket notification for a Class II medical device (acupuncture needles), not an AI algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this is not applicable. The device is an acupuncture needle, not an algorithm. Therefore, there is no "standalone" algorithm performance to assess.

7. The Type of Ground Truth Used

The "ground truth" for the device's acceptable performance is defined by compliance with established international standards for medical devices, specifically:

• ISO 17218: Acupuncture needles for single use
• ISO 10993-1: Biological evaluation of medical devices (biocompatibility)
• ISO 11607: Packaging for terminally sterilized medical devices
• ISO 11135: Sterilization of health care products - Ethylene oxide
• ISO 10993-7: Ethylene oxide sterilization residuals

8. The Sample Size for the Training Set

This is not applicable, as this is not an AI/machine learning study and thus there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no training set.

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