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Iontophoresis is indicated by clinicians 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.

Comfort Iontophoresis Electrodes (Buffered Iontophoresis Electrode Treatment Kit) consist of an active drug delivery electrode and a passive return electrodes are designed for one use on a single patient for the local administration of ionic drug solutions into the body for medical purposes. There are four sizes and for the roundinen a releaser of roles to accommodate placement on various locations on the body. The size of the return electrode is the same for all drug delivery electrode sizes as the maximum delivery of 80 milliamp-minutes is the same regardless of size. Comfort Iontophoresis Electrodes (Buffered Iontophoresis Electrode Treatment Kit) 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 abeling.

This 510(k) premarket notification for the Comfort Iontophoresis Electrodes (Buffered Iontophoresis Electrode Treatment Kit) does not describe a study to prove the device meets specific acceptance criteria based on its intrinsic performance. Instead, it relies on demonstrating substantial equivalence to predicate devices. This means that instead of conducting new performance studies, the manufacturer argues that their device is as safe and effective as devices already legally marketed.

Therefore, many of the requested sections below related to "acceptance criteria" and "study that proves the device meets acceptance criteria" are not directly applicable in the context of this 510(k) submission, as performance was demonstrated through comparison to known predicates, not independent testing against novel criteria.

Description of Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance

As this is a 510(k) submission based on substantial equivalence, there are no specific "acceptance criteria" in the traditional sense of performance metrics against a defined standard that the device itself had to meet in an independent study (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, the acceptance criteria are demonstrated through comparative equivalency to predicate devices. The "performance" is implicitly deemed equivalent if the device shares the same intended use, technological characteristics, and safety profile as the predicates.

The table below summarizes the similarities and equivalencies presented in the 510(k) to demonstrate that the proposed device performs identically to the predicate devices. The "acceptance criteria" here are effectively that the proposed device matches the established characteristics of the predicates.

The key "study" proving the device met the "acceptance criteria" was the detailed comparison of technical and functional characteristics against two predicate devices (North Coast Medical Buffered Iontophoresis Electrodes (K052019) and Dynatron Ion (K060814)). The core argument is stated explicitly: "In comparing the Comfort Iontophoresis Electrodes... it must be noted that there are no product differences since Axelgaard Manufacturing Co., Ltd. manufactures both these electrodes." This implies that the proposed device is literally the same product as the predicates, just marketed under a different name.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This 510(k) submission does not include an independent "test set" or clinical study with a sample size for performance evaluation. Approval is based on substantial equivalence to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth was established by experts for an independent test set. The "ground truth" for equivalence is rooted in the FDA's prior clearances of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring expert adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an iontophoresis electrode, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm, and its performance is not evaluated in a standalone or human-in-the-loop context. Its function is to facilitate drug delivery when connected to an iontophoresis machine and used by a medical professional.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the regulatory clearance and established safety and effectiveness profile of the predicate devices. The argument is that because the proposed device is identical to the predicates (even manufactured by the same company), its historical "performance" (safety and effectiveness) is already established through the predicates' market history and prior FDA clearances.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" for which ground truth would need to be established.

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