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Iontophoresis is indicated for the administration of soluble salts or other drugs into the body for medical purposes and can be used as an alternative to hypodermic injection.

North Coast Buffered Iontophoresis Electrodes consist of an active drug delivery clectrode and a passive return electrode. These electrodes are designed for one use by a single patient for the local administration of ionic drug solutions into the body for medical purposes. There are several sizes and shapes of drug delivery electrodes to accommodate placement on various locations on the body. The size of the return electrode is the same for all drug delivery electrode sizes. North Coast Buffered Iontophoresis Electrodes have technological characteristics equivalent to those of the predicate devices, including comparable design, materials, multiple shapes and sizes of active drug delivery electrodes, and equivalent packaging and labeling.

This document contains a 510(k) summary for the North Coast Buffered Iontophoresis Electrodes. It describes a medical device, and the information provided does not include the typical structure of an AI/ML device submission, which would detail acceptance criteria, study methodologies for performance evaluation, or ground truth establishment.

Therefore, I cannot answer your specific questions regarding acceptance criteria and the study proving the device meets them in the format requested. The document does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study details.
• Standalone performance details.
• Type of ground truth used.
• Sample size for training set.
• Ground truth establishment for the training set.

This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting a performance study against predefined acceptance criteria as would be expected for an AI/ML device.

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