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Seirin JR 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 Seirin JR Acupuncture Needle - is a sterile, single use only acupuncture needle. The Seirin JR Acupuncture Needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.

I am sorry, but the provided text is a 510(k) summary for an acupuncture needle. It describes the intended use, safety, and equivalence of the Seirin JR Acupuncture Needle to existing devices. However, it does not contain information about a study with acceptance criteria and device performance in the context of an AI/ML powered medical device.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method for the test set
• Multi-reader multi-case (MRMC) comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

This document is for a traditional medical device (acupuncture needle) and not an AI/ML powered device.

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