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Acupuncture needles are defined as devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

The subject of this 510(k) application - the CW acupuncture needle - is a sterile, single use only acupuncture needle. The CW acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.

The provided text is a 510(k) summary for an acupuncture needle, not a study evaluating an AI/ML device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, study design, expert involvement, or AI performance metrics.

The document focuses on demonstrating substantial equivalence of the "CW acupuncture needle" to legally marketed devices, primarily by highlighting its sterile, single-use nature and its history of safe use. It explicitly states: "The CW acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture." However, it does not detail specific quantitative acceptance criteria or a formal study with a test set, ground truth, or expert review that would typically be associated with performance evaluation of an AI/ML device.

Therefore, I cannot provide the requested table and information as it is not present in the given text.

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