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To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

The Magi acupuncture needle is a sterile surgical stainless steel, single use only acupuncture needle. The Magi 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 a medical device (Magi Acupuncture Needle) seeking clearance from the FDA. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a study with performance metrics.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, expert ground truth, or MRMC studies.

Instead, the document asserts:

• Substantial Equivalence: The Magi acupuncture needles are "substantially equivalent" to other legally marketed acupuncture needles.
• Safety Record: Since 1992, "no accident or device failure claims have been reported as a result of using the Magi acupuncture needle."
• Intended Use: "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."

Without a performance study, I cannot fill out the requested table or specify details about test sets, ground truth establishment, or statistical analysis.

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To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

The Dong Bang acupuncture needle is a sterile surgical stainless steel, single use only acupuncture needle. The Dong Bang acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.

The provided document is a 510(k) summary for the Dong Bang Acupuncture Needle and a subsequent FDA clearance letter. It does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to existing legally marketed devices, which is the basis for 510(k) clearance. The crucial aspects for your request are missing.

Therefore, I cannot provide the requested information, including the table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, types of ground truth, or training set information.

The only relevant statements from the document are:

• "The Dong Bang acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture." (This is a general claim, not supported by data in this document).
• "Since 1992, no accident or device failure claims have been reported as a result of using the Dong Bang acupuncture needle." (This is a safety claim based on past performance, not a study against specific acceptance criteria).

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