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These acupuncture needles are used to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Tai-Chi and Master acupuncture needles are sterile disposable, surgical s/steel acupuncture needles with spiral wound spring or rigid pipe type handles. These needles are supplied in individual blister or bulk packages. with or without polypropylene insertion tubes.

The provided text describes a 510(k) pre-market notification for Tai-Chi and Master Acupuncture Needles. It explicitly states that substantial equivalence is NOT based on an assessment of performance data. Instead, the equivalence is based on the devices having the "same technological characteristics" as predicate devices already on the market (K-003760 and K-962809).

Therefore, this document does not contain information about acceptance criteria, a study proving the device meets those criteria, or any of the other requested details regarding performance studies (sample sizes, ground truth, expert adjudication, MRMC, or standalone performance).

The only relevant information that can be extracted regarding the device and its regulatory pathway is:

Device Identification:

• Device Trade Name: Tai-Chi and Master Acupuncture Needles (other trade names may also be used)
• Common or Usual Name: Acupuncture Needles
• Device Classification Name: Needle, Acupuncture, Single Use
• Classification: Class II
• 510(k) Number: K-023787
• Indications for Use: These acupuncture needles are used to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Since no performance study was conducted or reported, the table of acceptance criteria and reported device performance cannot be generated. Similarly, all other requested information pertaining to study design and execution (sample sizes, data provenance, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) is absent from this document.

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