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The IO-Drive Iontophoresis electrode system consists of an active drug delivery electrode and a return electrode. These electrodes are designed for single patient use. There are multiple sizes of drug delivery electrodes to accommodate placement at different body sites. The size of the return electrode is the same size for all drug delivery electrodes.

AI/ML Overview

The provided document, K993081, describes the IO-DRIVE Iontophoresis electrode system. This submission is a 510(k) premarket notification, indicating that the device aims to demonstrate substantial equivalence to existing legally marketed predicate devices, rather than proving novel safety and effectiveness through extensive clinical trials.

Based on the provided information, the following can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence to Predicate Devices: The IO-Drive electrode system should function similarly to the Iomed TransQ (K91-4621) and Empi Dupel (K91-2014) in terms of delivering ionic drug solutions into the body via iontophoresis.	"A performance evaluation was performed and based on the evaluation the IO-Drive electrode is similar to the predicate electrodes."
Intended Use Equivalence: The device should have the same intended use as predicate devices.	"The electrode is intended to be used in the clinic. 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." This matches the general indications for iontophoresis devices.
Safety and Material Compatibility: While not explicitly detailed as acceptance criteria, substantial equivalence implies the materials and design are safe for single patient use as an external electrode.	The device consists of an active drug delivery electrode and a return electrode, designed for single patient use, with multiple sizes to accommodate different body sites. This description is consistent with typical iontophoresis electrode designs.
Manufacturing Quality: Compliance with Current Good Manufacturing Practice (GMP) requirements.	The FDA letter states: "A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions."

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

The document does not explicitly state a sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective study details). The "performance evaluation" mentioned is very high-level and does not provide these specifics. For a 510(k) submission focused on substantial equivalence, such detailed clinical trial data with specific test sets and provenance is often not required if the device is sufficiently similar to predicates and performance can be established through bench testing or limited clinical data.

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

This information is not provided in the document. Given the nature of a 510(k) submission relying on "performance evaluation" for substantial equivalence, it's unlikely that an extensive expert-adjudicated test set in the traditional sense was used to establish ground truth for a novel "device performance" metric. Instead, the "ground truth" for comparison would be the established performance characteristics of the predicate devices.

4. Adjudication Method for the Test Set

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed or reported in this document. The submission is for a medical device (electrode system), not an imaging or diagnostic AI algorithm, so an MRMC study would generally not be applicable in this context.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not performed or reported. This device is an electrode system for drug delivery, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this 510(k) submission is primarily performance characteristics and established safety/effectiveness profiles of the predicate devices. The IO-Drive electrode system's "performance evaluation" aimed to show similarity to these predicates. The FDA's substantial equivalence determination implies that the new device is as safe and effective as the predicate devices based on available information, which might include design comparisons, material testing, and limited functional testing, rather than an independent "ground truth" based on clinical outcomes.

8. Sample Size for the Training Set

This information is not applicable/not provided. The IO-Drive system is an electrode, not an AI algorithm, so there is no concept of a "training set" in this context.

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

This information is not applicable/not provided for the same reasons as above.

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