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Iontophoresis Electrodes are intended to be used to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.

The proposed device is indicated for the administration of soluble salts or other drugs into the body for medical purposes. The Iontophoresis Electrodes utilize adhesive electrodes have both anode and cathode electrodes that adhere to the skin. The electrodes may either be connected by leads (wires) to a separate controller Forming a current loop. The portion of the active electrode that contacts the skin also has a drug/solution reservoir. End users saturate the reservoir with the ionic solution to be delivered. The reservoir contacts the electrode and the drug/solution is delivered to the patient transdermally.

Five models (Small, Medium, Large, Butterfly and Return Electrode) are included in this series products, and they have the same intended purposes, working theories and specifications.

The provided document describes the acceptance criteria and the study that proves the device meets those criteria for the Iontophoresis Electrodes (K232020).

Here's the breakdown of the requested information:

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

The document presents a comparison to a predicate device (Iontophoresis Drug Delivery Electrodes, K040495) to demonstrate substantial equivalence, rather than setting explicit numerical acceptance criteria for a new device's performance. The "acceptance criteria" are implied by the predicate device's specifications and the non-clinical test conclusions.

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

The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no sample size for a clinical test set or information on its provenance. The testing was non-clinical.

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, as no clinical study was conducted that would require expert ground truth. The evaluation focused on non-clinical performance and safety based on recognized standards.

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

Not applicable, as no clinical study was conducted.

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, which is a physical device for drug delivery, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

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

Not applicable. This is a physical medical device, not an algorithm or software.

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

Not applicable, as no clinical study was conducted. The "ground truth" for the non-clinical tests was established by compliance with international standards (IEC 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, ISO 10993-23) and comparison to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model.

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

Not applicable. This is a physical medical device, not a machine learning model.

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