Search Results

Acupuncture Needles are intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a device called "Maeda Silver Acupuncture Needle Disposable." This type of document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, as it pertains to a medical device that does not typically involve complex algorithms or performance metrics in the same way as, for example, an AI-powered diagnostic tool.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. It does not include:

1. A table of acceptance criteria and reported device performance: This is not relevant for an acupuncture needle in a 510(k) submission of this nature. Performance is generally assumed to be equivalent to existing devices.
2. Sample size used for the test set and data provenance: No such test set is described.
3. Number of experts used to establish ground truth and their qualifications: Not applicable.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not an AI-powered diagnostic device.
6. Standalone (algorithm only) performance study: Not applicable, as no algorithm is involved.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

The document primarily focuses on regulatory approval based on substantial equivalence, not on a detailed performance study as would be seen for more complex or novel medical devices, especially software as a medical device (SaMD) or AI-driven systems.

Ask a specific question about this device