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The TeWa Acupuncture Needle is a device intended 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) clearance letter for TeWa Acupuncture Needles and does not contain the requested information regarding acceptance criteria and performance study details. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the specific details you've asked for, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, expert qualifications, or adjudication methods for test sets.
• Information on MRMC studies or standalone algorithm performance.
• The type of ground truth used or details about training sets.

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Intended 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 approval letter for acupuncture needles. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, ground truth types, or training set details) from the provided document.

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The acupuncture needle is a device intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

asia-med acupuncture needles (Special+, s-needle B-Type and s-needle J-Type) for single use.

The provided text is a 510(k) Premarket Notification letter from the FDA to Asia-Med GmbH and CO KG regarding their acupuncture needles. It is a regulatory document confirming that the device has been found substantially equivalent to a legally marketed predicate device.

This document DOES NOT contain information about acceptance criteria, device performance studies, or clinical trial data. It is purely a regulatory approval notice. Therefore, I cannot extract the requested information regarding acceptance criteria and studies from this text.

The information you are asking for (acceptance criteria, sample sizes, expert qualifications, study types, etc.) would typically be found in the 510(k) submission itself, or in supporting documentation such as a clinical study report or a validation report, which are not part of this FDA clearance letter.

Ask a specific question about this device

The acupuncture needle is a device intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

asia-med acupuncture needles (Special, Standard, Compact and Apex) for single use.

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for acupuncture needles. It does not contain information about acceptance criteria, device performance, a study, or any of the other specific details requested in your prompt.

Therefore, I cannot provide the requested information based on the input text.

Ask a specific question about this device