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Iontophoretic drug delivery devices are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections. They are also indicated for iontophoretic dermal administration of IONTOCAINE® (Lidocaine HCl 2% and Epinephrine 1:100,000 Topical Solution).

An iontophoresis device is a device that is intended to use electrical current to introduce ions of water-soluble salts or drugs into the body for medical purposes. Iontophoresis technology is based on the principle that an electric potential will cause ions in solution to migrate according to their electrical charges. The quantity and distribution of a drug delivered into and across the skin by iontophoresis is dependent on the charge and molecular weight of the ion, the magnitude of the electrical current applied, patch composition, duration of current flow, and numerous other factors.

The IOMED, Inc. Champion integrated transdermal patch incorporates both a drug electrode and a return electrode. The patch is designed for a single-patient, oneapplication use and can only be used with IOMED's Champion dose controller. The Champion dose controller provides control of the current and therefore dosage delivered.

The Champion dose controller is a small, battery-powered, microprocessor-controlled iontophoretic device which delivers direct current (DC) to the integrated transdermal patch which is placed on intact skin.

The provided document, K063465, is a 510(k) premarket notification for the "Champion Iontophoresis Drug Delivery System." This submission focuses on establishing substantial equivalence to predicate devices and demonstrating general safety and effectiveness through in vitro drug delivery and biocompatibility testing. It is not a study describing acceptance criteria and device performance in the context of a typical algorithm or diagnostic device evaluation.

Therefore, many of the requested elements are not applicable or cannot be extracted from this document, as they pertain to clinical trials, algorithm performance metrics, or expert adjudication which are not relevant to the approval of this physical drug delivery device.

However, I can extract information related to the in vitro testing and safety assessments that were presented as part of the submission to demonstrate the device's functionality and safety.

Here's a breakdown of the available and unavailable information based on your request:

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

Note: The document does not explicitly state quantitative "acceptance criteria" in the format typically seen for algorithm performance (e.g., sensitivity, specificity thresholds). Instead, it describes tests performed and their outcomes which serve to demonstrate the device's functionality and safety in comparison to predicate devices and established standards.

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated in terms of specific numbers of skin samples or animals for the in vitro drug delivery study. The description "freshly excised hairless mouse skin" suggests a number of samples were used, but the exact count is not given. For biocompatibility, "rabbits" were used, but the number is not specified in this summary.
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: The studies described (in vitro drug delivery, primary dermal irritation) were experimental studies performed for the submission, making them prospective in nature regarding the data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This is not an expert-driven adjudication of images or clinical cases. The "ground truth" for the drug delivery study was the quantified amount of drug in skin/receptor solution, measured scientifically. For biocompatibility, it was based on established dermal irritation scoring methods.

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

• Not applicable. No adjudication by human readers/experts was involved in these in vitro and animal studies.

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 is not an AI/algorithm-assisted diagnostic device, nor is it a multi-reader study.

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

• Not applicable. This is a physical drug delivery device, not an algorithm.

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

• Drug Delivery: The "ground truth" was quantitative measurement of drug concentration in skin and receptor solution using radioassay (3H and 14C tracers).
• Biocompatibility/Irritation: The "ground truth" was the Primary Dermal Irritation Index score, which is an objective measurement of skin reaction (e.g., erythema, edema) based on a standardized scale, typically observed and scored by trained personnel.

8. The sample size for the training set

• Not applicable. This is not a machine learning device; therefore, there is no "training set."

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

• Not applicable (as there is no training set).

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