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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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Iontophoresis is indicated by clinicians for the administration of soluble salts or other drugs into the body for medical purposes and can be used as an alternative to hypodermic injection.

Comfort Iontophoresis Electrodes (Buffered Iontophoresis Electrode Treatment Kit) consist of an active drug delivery electrode and a passive return electrodes are designed for one use on a single patient for the local administration of ionic drug solutions into the body for medical purposes. There are four sizes and for the roundinen a releaser of roles to accommodate placement on various locations on the body. The size of the return electrode is the same for all drug delivery electrode sizes as the maximum delivery of 80 milliamp-minutes is the same regardless of size. Comfort Iontophoresis Electrodes (Buffered Iontophoresis Electrode Treatment Kit) have technological characteristics equivalent to those of the predicate devices, including comparable design, materials, multiple shapes and sizes of active drug delivery electrodes, and equivalent packaging and abeling.

This 510(k) premarket notification for the Comfort Iontophoresis Electrodes (Buffered Iontophoresis Electrode Treatment Kit) does not describe a study to prove the device meets specific acceptance criteria based on its intrinsic performance. Instead, it relies on demonstrating substantial equivalence to predicate devices. This means that instead of conducting new performance studies, the manufacturer argues that their device is as safe and effective as devices already legally marketed.

Therefore, many of the requested sections below related to "acceptance criteria" and "study that proves the device meets acceptance criteria" are not directly applicable in the context of this 510(k) submission, as performance was demonstrated through comparison to known predicates, not independent testing against novel criteria.

Description of Acceptance Criteria and Device Performance

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

As this is a 510(k) submission based on substantial equivalence, there are no specific "acceptance criteria" in the traditional sense of performance metrics against a defined standard that the device itself had to meet in an independent study (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, the acceptance criteria are demonstrated through comparative equivalency to predicate devices. The "performance" is implicitly deemed equivalent if the device shares the same intended use, technological characteristics, and safety profile as the predicates.

The table below summarizes the similarities and equivalencies presented in the 510(k) to demonstrate that the proposed device performs identically to the predicate devices. The "acceptance criteria" here are effectively that the proposed device matches the established characteristics of the predicates.

The key "study" proving the device met the "acceptance criteria" was the detailed comparison of technical and functional characteristics against two predicate devices (North Coast Medical Buffered Iontophoresis Electrodes (K052019) and Dynatron Ion (K060814)). The core argument is stated explicitly: "In comparing the Comfort Iontophoresis Electrodes... it must be noted that there are no product differences since Axelgaard Manufacturing Co., Ltd. manufactures both these electrodes." This implies that the proposed device is literally the same product as the predicates, just marketed under a different name.

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

Not applicable. This 510(k) submission does not include an independent "test set" or clinical study with a sample size for performance evaluation. Approval is based on substantial equivalence to existing devices.

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. No ground truth was established by experts for an independent test set. The "ground truth" for equivalence is rooted in the FDA's prior clearances of the predicate devices.

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

Not applicable. No test set requiring expert adjudication was used.

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, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.

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

Not applicable. This device is not an algorithm, and its performance is not evaluated in a standalone or human-in-the-loop context. Its function is to facilitate drug delivery when connected to an iontophoresis machine and used by a medical professional.

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

The "ground truth" in this context is the regulatory clearance and established safety and effectiveness profile of the predicate devices. The argument is that because the proposed device is identical to the predicates (even manufactured by the same company), its historical "performance" (safety and effectiveness) is already established through the predicates' market history and prior FDA clearances.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no "training set" for which ground truth would need to be established.

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The Pepin Manufacturing, Inc. iontophoresis electrodes are intended to be used to introduce soluble salts and other dugs into the body.

Iontophoresis electrodes described in this application are single patient use, disposable, nonsterile devices. Fundamentally the iontophoresis electrodes consist of two skin contacting electrodes: a drug delivery electrode and a return electrode. When connected to the user's iontophoresis electronic device, the electrodes localize administration of ionic drug solutions into the body for medical purposes.

The electrodes provide the patient contact device. The electrodes are used under the supervision of a physician or other medical professional. The iontophoresis electrodes are intended for use only with approved drugs delivered by iontophoresis technology.

There are variations of sizes and shapes of the drug delivery electrode. The size of the return electrode is constant for all drug delivery electrode variations. The iontophoresis electrodes do not include lead wires. The electrode electrical contact is made by a snap on the electrode.

lontophoresis electrodes are used under the direct supervision of a physician or medical professional. The electrodes are placed in contact with the skin to support introduction of soluble salts and other dugs into the body.

The iontophoresis electrodes do not contain active electronics, software or firmware. The electrodes connect to the user's iontophoresis electronic device. The drug delivery electrode is a buffed gel covered carbon electrode. The return electrode is a buffered hydrogel material electrode. Electrode material biocompatibility is addressed in the submission.

This 510(k) summary (K060579) describes an Iontophoresis Drug Delivery System Electrodes by Pepin Manufacturing, Inc. However, it does not contain the specific information required to complete a comprehensive table of acceptance criteria and a detailed study report. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use.

Here's an analysis of what can be extracted and what is missing based on your request:

1. Table of acceptance criteria and the reported device performance

This information is not present in the provided text. The document states: "Verification of performance and labeling are provided in the submission," but the actual acceptance criteria or performance data itself is not included in this 510(K) summary.

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

This information is not present in the provided text. No specific studies with test sets, sample sizes, or data provenance are described.

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)

This information is not present in the provided text. As no specific test studies are detailed, there is no mention of experts establishing ground truth.

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

This information is not present in the provided text.

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

This information is not present in the provided text. The device is an iontophoresis electrode, not an AI or imaging device that would typically involve human readers or MRMC studies.

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

This information is not present in the provided text. The device is an electrode and does not involve an algorithm.

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

This information is not present in the provided text.

8. The sample size for the training set

This information is not present in the provided text. This device is not an AI/ML algorithm that would typically have a "training set."

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

This information is not present in the provided text.

Summary of available information regarding acceptance criteria and study:

The provided document (K060579) for the Pepin Manufacturing, Inc. Iontophoresis Drug Delivery System Electrodes is a 510(k) summary report. The general approach for this type of device (iontophoresis electrodes) to gain FDA clearance is through demonstrating substantial equivalence to already legally marketed predicate devices, rather than through extensive clinical trials with specific acceptance criteria and detailed study reports as might be required for novel or high-risk devices, especially those involving AI/ML.

The key acceptance criteria for this device, as implied by the submission, are:

• Technological Characteristics Equivalence: The electrodes must have equivalent technological characteristics to predicate iontophoresis electrodes, including performance specifications, materials, sizes, packaging, and labeling.
• Biocompatibility: The electrode materials must be biocompatible.
• Intended Use Equivalence: The intended use (introducing soluble salts and other drugs into the body) must be equivalent to predicate devices.
• Safety and Effectiveness: The device should not raise new questions of safety or effectiveness.

Study/Evidence presented in the document:

The "study" or evidence presented in this 510(k) is a comparison to predicate devices rather than a standalone performance study with detailed numerical results against acceptance criteria.

The document states:

• "The iontophoresis electrodes have the equivalent technological characteristics to predicate iontophoresis electrodes, including performance specifications, materials, sizes, packaging and labeling."
• "Verification of performance and labeling are provided in the submission." (However, the details are not in this summary.)
• "The Pepin Manufacturing, Inc. iontophoresis electrodes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised."

The predicate devices listed are:

• K031053, Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes
• K914264, K925800, K933620, Iomed, Inc. Iontophoresis Drug Delivery Electrodes
• K040495, North American Industrial Manufacturing Company, Naimco, Inc. Iontophoresis Drug Delivery Electrodes

In conclusion, this 510(k) summary demonstrates substantial equivalence by asserting that the device shares the same fundamental principles and characteristics as established predicate devices, and that detailed performance verification was provided in the full submission, but the specific metrics and study details are not publicly available in this summary.

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The Dupel® II Buffered Iontophoresis Electrodes are designed for use with the Dupel Iontophoresis System (K903093) which is indicated for the local administration of ionic solutions into the body for medical purposes and can be used as an alternative to injections.

The Dupel® II 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 160mAmin 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.

This document describes the safety and effectiveness information for the Dupel® II Buffered Iontophoresis Electrode System.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the modified Dupel® II electrode was compared to the predicate Empi Buffered Iontophoresis Electrode (K912015). The performance was assessed against product specifications.

Note: The document explicitly states, "The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements, is acceptable for its intended use and is equivalent to the predicate electrodes."

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

• Sample Size: Not explicitly stated. The document refers to "functional testing" and "design qualification tests" but does not provide specific numbers for units tested.
• Data Provenance: The study was conducted as part of the 510(k) submission by Empi, Inc., based in St. Paul, Minnesota, USA. It is a retrospective analysis comparing a modified device to a previously cleared predicate device.

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

Not applicable. This is not a study involving human interpretation of medical images or data where expert ground truth is typically established. The testing focused on technical performance parameters of an electrode.

4. Adjudication Method for the Test Set

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

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

No. An MRMC study is typically used for diagnostic or screening devices where human readers interpret medical data. This study is an engineering and functional performance assessment of an electrode.

6. Standalone (Algorithm Only) Performance Study

No. This device is an electrode, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

The ground truth or reference standard for this study was product specifications and the performance of the predicate device. The modified device was evaluated against these established benchmarks for equivalence.

8. Sample Size for the Training Set

Not applicable. This is a medical device performance study, not an AI/Machine Learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device study.

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