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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

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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