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Iontophoretic drug delivery electrodes 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 a direct current to introduce ions of soluble salts or other 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 strength of the electrical current applied, electrode composition, duration of current flow, and numerous other factors.

The RH-900 consists of an active delivery electrode and a passive return electrode. Both electrodes have buffering capability for up to an 80mA-min treatment. These electrodes are designed for a single-patient, one-application use.

This electrode is recommended for use with the Phoresor® Iontophoretic Drug Delivery Systems (Iomed, Inc., Salt Lake City, UT 84120). This system is a 9-volt battery powered, solid state, microprocessor-controlled device that controls current levels and duration, calculates total charge delivered and monitors current flow and electrode/skin impedance.

The RH-900 electrode consists of a dry, monolithic, impregnated nonwoven polyester fabric liquid containment element designed to be hydrated with an aqueous solution immediately prior to use. It also has a carbon conductive element and an adhesive tape border for skin fixation. All components in contact with the skin are known GRAS materials and/or are listed in the National Formulary.

The provided document describes the RH-900 Iontophoresis Electrode and its comparison to predicate devices, focusing on drug delivery capabilities and biocompatibility. The document does not describe a clinical study in the typical sense with patient outcomes, nor does it involve an AI/ML device. Therefore, it does not contain information about acceptance criteria in the context of clinical performance metrics like sensitivity, specificity, or accuracy, and does not provide details like sample sizes for test sets, expert qualifications, or MRMC studies for AI/ML devices.

However, I can extract the acceptance criteria (or rather, performance benchmarks) and the study (technical testing) used to demonstrate the device meets those benchmarks based on the information provided for this medical device (an iontophoresis electrode).

Here's the information structured to best fit your request, with strong caveats that this is not an AI/ML device study:

Acceptance Criteria and Study for Iomed RH-900 Iontophoresis Electrode

This document describes the safety and effectiveness of the RH-900 Iontophoresis Electrode by comparing its drug delivery and biocompatibility to predicate devices. It establishes performance through in vitro drug transport studies and in vivo dermal irritation studies.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Drug Delivery: The sample size for the in vitro hairless mouse skin model is not explicitly stated. The provenance is from a laboratory study ("in vitro by methods described by Petelenz et al., J Controlled Release 20 (1992), 55-56"). No country of origin is specified for the lab or samples.
• Biocompatibility (Primary Dermal Irritation): Rabbits were used. The specific number of rabbits is not provided. The study was conducted in accordance with FDA regulations for Good Laboratory Practices (GLP) and ISO 10993-10:2002.
• Biocompatibility (Cytotoxicity): The sample size for the in vitro cytotoxicity testing of the hydratable non-woven material is not specified. The testing followed GLP procedures and referenced USP and ISO 10993-10 requirements.

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

This type of information is not applicable as this is not a study assessing diagnostic performance by human experts. The "ground truth" for drug delivery was established by quantitative measurement of radiolabeled drug transport. The "ground truth" for dermal irritation and cytotoxicity was established by standardized laboratory testing protocols (GLP, ISO 10993-10) with objective scoring criteria, not by human expert consensus on images or interpretations.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert opinions.

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 not an AI/ML product and does not involve human readers interpreting output.

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

Not applicable. This is a non-AI medical device. The "standalone" performance here refers to the device's inherent physical and chemical properties and interaction with biological systems, as tested in the laboratory.

7. The Type of Ground Truth Used

• Drug Delivery: Quantitative measurement of radiolabeled drug transport across hairless mouse skin (in vitro model).
• Biocompatibility (Primary Dermal Irritation): Objective scoring of dermal reactions in rabbits based on predefined scales (0.0 to 8.0), as per ISO 10993-10:2002 and GLP.
• Biocompatibility (Cytotoxicity): Standardized in vitro cytotoxicity assays yielding a grade on a 0-4 scale, as per USP and ISO 10993-10.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant to the provided document.

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