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Medical Adhesivesonline, LLC. Iontophoresis Drug Delivery Electrodes are intended to be used to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.

The Medical Adhesivesonline, LLC. Iontophoresis Drug Delivery Electrode System consists of an active drug delivery electrode 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 multiple sizes and shapes of drug delivery electrodes to accommodate placement various sites on the body. The size of the return electrode is the same for all drug delivery electrode sizes. The Medical Adhes. Iontophoresis Drug Delivery Electrodes have technological characteristics equivalent to those of the predicate devices, including comparable performance specifications, comparable materials including the same buffering agent (Ag/AgCl) and polyurethane foam reservoir materials on the active drug delivery electrodes and the same buffering, self-adhering polymer on the return electrode, multiple shapes and sizes of active the drug delivery electrodes, and equivalent packaging and labeling.

The provided text is a 510(k) summary for Medical Adhesivesonline, LLC. Iontophoresis Drug Delivery Electrodes. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria in the way a clinical trial or algorithm validation study would.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, adjudication methods, and comparative effectiveness studies is not available in the provided text.

Medical device 510(k) submissions for devices like iontophoresis electrodes typically rely on demonstrating that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device. This often involves comparing material specifications, performance specifications (e.g., electrical characteristics, drug delivery rates, biocompatibility), and labeling, rather than conducting new clinical trials with defined acceptance criteria for outcomes like accuracy or sensitivity/specificity in the context of diagnostic AI.

In summary, the provided document does not contain the information required to populate the requested table and answer the study-specific questions.

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