Search Results

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

Stainless steel disposable acupuncture needles. Sterilized by ETO.

The provided text is a 510(k) summary for ADDIQUIP disposable acupuncture needles (K981272). It describes the device, its intended use, and its substantial equivalence to a predicate device (CARBO (K961339) acupuncture needles).

*However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt regarding a device's performance study.

The 510(k) summary confirms the device's substantial equivalence to a legally marketed predicate device (CARBO acupuncture needles) based on general characteristics and intended use, rather than a detailed performance study with specific acceptance criteria that would typically be described in a clinical or validation report.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance
2. Sample sizes used for test set and data provenance
3. Number of experts and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance results
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

This type of information is not typically presented in a 510(k) summary for a device like acupuncture needles, which are often cleared based on substantial equivalence to existing devices without requiring extensive de novo performance studies with quantitative metrics like sensitivity or specificity. Devices like these are usually assessed for material safety, sterility, and appropriate labeling, which are confirmed through manufacturing processes and comparison to legally marketed devices.

Ask a specific question about this device