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Iontophoresis drug delivery systems are indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.

The Dupel® Buffered Iontophoresis Electrode System consists of an active drug delivery electrode and a passive return electrode. Both electrodes have buffering capability for up to a 160mA min treatment session. These electrodes are designed for single patient, one application use. There are multiple sizes and shapes of drug delivery electrodes to accommodate placement at different body sites. The size of the return electrode is the same for all drug delivery electrode sizes.

The provided text describes non-clinical tests for the "Duple B.L.U.E Small Iontophoresis Electrode" (referred to as "the device" or "small electrode") and a performance evaluation (clinical test) comparing it to a predicate electrode.

Here's an analysis of the acceptance criteria and the study as described:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Non-Clinical Animal Tests: A "standard Primary Dermal Irritation Index scores" was used. The text states "the small electrode and the currently marketed small electrode was rated as a non-irritant or irritation barely perceptible after the 1st treatment". No specific number of animals is provided, but it implies a standardized animal model study. This would be a prospective study. The country of origin is not specified but would likely be the USA, where Empi, Inc. is located.
• Clinical Tests: A "performance evaluation of the new small electrode was conducted." The results are described as "preliminary results." No specific sample size (number of human subjects) is given. This was a prospective clinical study. The country of origin is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Non-Clinical Animal Tests: It states "rated as a non-irritant or irritation barely perceptible". This implies evaluation by trained personnel, likely a veterinarian or toxicologist, interpreting the Primary Dermal Irritation Index scores. No specific number or qualifications are given in the document.
• Clinical Tests: "Preliminary results" were used to assess similarity to the predicate electrode. This assessment likely involved healthcare professionals evaluating the observed irritation, comfortable current, conformance, adherence, and leakage. No specific number or qualifications of these "experts" are provided.

4. Adjudication Method for the Test Set

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for either the non-clinical or clinical tests. The evaluation seems to be based on direct observation and measurement against predefined criteria.

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

• No, an MRMC comparative effectiveness study was not done. The device is an iontophoresis electrode, not an AI-assisted diagnostic tool. The "clinical tests" compare the new small electrode to a predicate electrode, not to human readers, and no AI is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable as this is a medical device (electrode), not an algorithm or AI system. The non-clinical tests evaluate the device's physical and chemical properties in a standalone manner.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Non-Clinical Animal Tests: The "ground truth" was established by standardized evaluation using the Primary Dermal Irritation Index scores. This is a well-established, objective scoring system for dermal irritation.
• Clinical Tests: The "ground truth" for comparison appears to be the performance characteristics of the predicate electrode. The new electrode's performance was compared to this established baseline for irritation, comfortable current, conformance, adherence, and leakage. This comparison doesn't rely on a "ground truth" in the diagnostic sense (like pathology), but rather on directly observed and measured performance characteristics relative to a benchmark.

8. The Sample Size for the Training Set

• Not applicable. The document describes a medical device undergoing pre-market evaluation, not an AI or machine learning model that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no training set for an AI model.

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