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

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This document is a 510(k) premarket notification letter from the FDA regarding a medical device called "Seven Star Needle." It establishes substantial equivalence for the device for the stated indications for use.

Based on the provided text, the document does not contain the detailed acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for AI/ML-based medical devices. This is a notification for an acupuncture needle, which is a traditional medical device, not a software-based or AI-driven diagnostic/prognostic tool. Therefore, many of the questions asked in the prompt, such as those related to AI performance, sample sizes for test/training sets, expert adjudication, or MRMC studies, are not applicable to the content of this document.

The document primarily focuses on:

• Confirming the device's substantial equivalence to a legally marketed predicate device.
• Stating the intended use of the device (to pierce the skin in the practice of acupuncture by qualified practitioners).
• Regulatory classification (Class II, Product Code MQX).
• General regulatory requirements for the manufacturer.

Since the prompt asks for information that is not present in the document for a device of this nature, I will explicitly state where the information is not provided.

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not provided in this document. For a traditional medical device like an acupuncture needle, acceptance criteria would typically relate to manufacturing specifications, material biocompatibility, sterility, needle sharpness, and structural integrity, rather than performance metrics like sensitivity or specificity. These details would be in the full 510(k) submission, not the FDA's final decision letter.
• Reported Device Performance: Not provided in this document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable/Not provided. This document pertains to a traditional medical device, not one that undergoes performance evaluation with a "test set" in the context of AI/ML.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided.

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

• Not applicable/Not provided. This device is an acupuncture needle, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable/Not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not provided. Ground truth is not relevant for this type of device in the context of this document. The "ground truth" for an acupuncture needle would be its physical properties and functionality.

8. The sample size for the training set

• Not applicable/Not provided.

9. How the ground truth for the training set was established

• Not applicable/Not provided.

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