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Sterile with E.O.G. . 'Caution: Acupuncture needles are device intend to pierce the skin in the practice of acupuncture by qualified practitioners as determined by states'

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The provided document is a 510(k) clearance letter from the FDA for an Acupuncture Needle (K071524). It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this type of document does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for a diagnostic or AI-driven medical device.

The 510(k) pathway for a device like an acupuncture needle focuses on demonstrating substantial equivalence to a predicate device, often through evidence like:

• Physical/material specifications and comparisons.
• Sterilization methods.
• Biocompatibility testing (if applicable).
• Labeling.
• Performance testing related to its mechanical function (e.g., needle strength, sharpness, sterility maintenance).

There is no mention of a study involving expert readers, AI assistance, or complex performance metrics that would be typically found in a clearance for a diagnostic imaging device or an AI/ML medical device.

Therefore, I cannot fulfill the request using the provided input.

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