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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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The provided text is a 510(k) premarket notification letter from the FDA to Helio Medical Supplies, Incorporated regarding their Press Tack/Intradermal Acupuncture Needles. This document is a regulatory approval letter and does not contain information about acceptance criteria or a study proving device performance as typically understood for medical device AI/algorithm submissions.

Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on:

• Device Name: Press Tack/Intradermal Acupuncture Needles
• Regulatory Classification: Class II
• Product Code: MQX
• Submission Date and Receipt Date: February 3, 2005 / February 7, 2005
• FDA Determination: Substantially equivalent to a legally marketed predicate device.
• Indications for Use: To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
• Prescription Use status: Prescription Use.

To address your request, I would need a document that presents a clinical or performance study for a medical device, ideally one involving an AI or algorithmic component, which would then detail its acceptance criteria and the results of the study.

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