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To conduct electrical stimulation to a patient's skin.
Single patient use.
Repositionable, self-adhering.
Over the counter use.

The electrode is used in conjunction with electrical stimulating therapy for the symptomatic relief and management of chronic pain or some types of acute pain, muscle stimulation therapy for the relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, and maintaining or increasing range of motion.

The device provides a means for establishing electrical contact between the lead connected to a TENS, FES, or NMES stimulation device and the skin. The device consists of conductive hydrogel, a conductive lead wire, a non-conductive cloth backing material with a printed conductor on the side contacting the hydrogel.

The provided document describes the acceptance criteria and the study conducted to prove that TENS/FES/NMES electrodes meet these criteria.

Here's the breakdown as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample size used for the impedance or skin sensitivity testing.

The provenance of the data is from Uni-Patch internally, comparing their electrodes to existing legally marketed devices. It appears to be prospective testing conducted by Uni-Patch to support their 510(k) submission.

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

Not applicable. The ground truth for impedance was established by direct measurement and comparison to similar devices, not by expert consensus on interpretations. For skin sensitivity, the "Tripartite Biocompatability Guidance for Medical Devices" sets the standard, which is a regulatory guideline, not expert consensus on individual cases.

4. Adjudication Method for the Test Set

Not applicable, as the acceptance criteria were based on quantitative measurements (impedance) and compliance with established biocompatibility guidelines. There was no need for an adjudication method as would be used for subjective assessments.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The evaluation focused on the technical performance characteristics of the device itself (impedance and biocompatibility) rather than how human readers' performance might improve with AI assistance. This device is an electrode, not an AI-powered diagnostic tool.

6. If a Standalone Performance Study Was Done

Yes, a standalone performance study was done for the device. The reported impedance levels and skin sensitivity test results reflect the performance of the Uni-Patch electrodes themselves, independent of any human interaction beyond the application of the electrode for testing.

7. The Type of Ground Truth Used

• Impedance: The ground truth was established by comparing the measured impedance values of the Uni-Patch electrodes to the measured impedance values of "legally marketed electrodes" (Medtronic ComfortEase and 3M Myocare) which are presumed to be safe and effective based on their prior approval.
• Skin Sensitivity: The ground truth was established by conformance to "Tripartite Biocompatability Guidance for Medical Devices," which provides established criteria for biocompatibility.

8. The Sample Size for the Training Set

Not applicable. This device is an electrode, not a machine learning algorithm, therefore there is no "training set" in the context of AI.

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

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

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Transcutaneous Electrical Nerve Stimulation (TENS) and Muscle Stimulation (NMES/FES) Electrodes

The provided text is a summary of safety and effectiveness for Uni-Patch TENS and Muscle Stimulation Electrodes, comparing them to previously cleared devices. It does not contain a detailed study with specific acceptance criteria and performance metrics in the format requested.

However, I can extract the relevant information and present it in the closest possible format based on the provided text.

Here's an attempt to structure the information as requested, acknowledging the limitations of the provided document:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The Uni-Patch Transcutaneous Electrical Nerve Stimulation (TENS) and Muscle Stimulation (NMES/FES) Electrodes aim to be as safe and effective as the Axelgaard Manufacturing Company Pals® Plus Reusable Neurostimulation Electrode and the LMI Spec T.E.N.S. Repositionable Pin-Type TENS Electrode (K894042A). The primary safety concern addressed was skin irritation, and effectiveness was determined by comparing impedance levels.

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

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

• Sample Size: Not specified in the document for the impedance testing or gel testing.
• Data Provenance: The document states that the RG-60 Series gels have passed specific biocompatibility tests and have been used in other cutaneous electrodes manufactured by Uni-Patch. The impedance testing was conducted by Uni-Patch. This suggests retrospective data for the gel's biocompatibility from prior uses/tests, and prospective internal testing for the impedance comparison. The country of origin for the data is not explicitly stated but likely internal to Uni-Patch (USA, given the address).

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The biocompatibility testing likely involved certified labs and personnel, but no details are provided. For impedance testing, it was likely conducted by Uni-Patch's internal technical staff.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/not described. This document reports the outcome of tests rather than an expert review process.

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

• MRMC Study: No, this is not an MRMC study. The device is an electrode, not an AI imaging or diagnostic tool.

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

• Standalone Performance: Not applicable. This refers to the performance of a physical medical device (electrodes), not an algorithm or AI. The assessment of skin irritation and electrical impedance are inherent properties of the device components.

7. The type of ground truth used

• Ground Truth for Safety (Skin Irritation): Established by adherence to published criteria/standards (Tripartite Biocompatibility Guidance For Medical Devices) through various in vitro and in vivo (e.g., dermal sensitization) tests.
• Ground Truth for Effectiveness (Impedance): Established by direct comparison of the Uni-Patch electrode's measured impedance values against those of the identified predicate devices, based on a specific measurement method (1K-Hz drive).

8. The sample size for the training set

• Sample Size: Not applicable. The document describes a comparison test for a physical device, not an AI model requiring a training set.

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

• Ground Truth Establishment: Not applicable, as there is no training set for an AI model.

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Repositionable TENS and EMS Electrodes with RG-60 Series Gel

Transcutaneous Electrical Nerve (TENS) and Muscle Stimulation (NMS/FES) electrodes

Here's an analysis of the provided text regarding the acceptance criteria and study for the Uni-Patch Repositionable TENS and EMS Electrodes:

Please note that the provided text is a 510(k) Premarket Notification Summary of Safety and Effectiveness from 1996. This type of document predates many of the standardized AI/ML study reporting requirements. As such, some of the requested information (especially regarding AI-specific details like MRMC or standalone algorithm performance, and detailed ground truth provenance for training sets) is not applicable or not present in this document, as the device described is not an AI/ML device but a medical electrode.

Acceptance Criteria and Study for Uni-Patch Repositionable TENS and EMS Electrodes with RG-60 Series Gel

The Uni-Patch electrodes are deemed safe and effective by demonstrating substantial equivalence to predicate devices (Medtronic, 3M, and LMI electrodes). The safety and effectiveness are established through specific criteria and testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Skin Irritation Tests: The document states that the RG-60 Series gels "have passed the required skin sensitivity testing criteria." It lists the types of tests (Cytotoxicity, Dermal Sensitization Study, Repeat Insult Patch Test, Primary Skin Irritation Test). However, the specific sample sizes for these tests are not disclosed in this summary.
• Impedance Testing: The document states "we have determined that the electrode impedance values were comparable to all the electrodes tested." The sample size of electrodes tested for impedance (both Uni-Patch and predicate devices) is not disclosed.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of biocompatibility and electrical performance testing, these would typically be prospective laboratory and/or animal/human studies conducted to specific protocols.

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

• Not Applicable in the context of this device. The "ground truth" for the skin irritation tests would be derived from standardized biological test results (e.g., cell viability in cytotoxicity, observed reactions in sensitization tests) as per the Tripartite Biocompatibility Guidance. The "ground truth" for impedance would be objective measurements from electrical test equipment. There is no mention of experts establishing ground truth in the way it's understood for diagnostic imaging or clinical outcomes.

4. Adjudication Method for the Test Set

• Not Applicable. Since the "ground truth" is based on objective biological and electrical measurements rather than subjective human assessment, there is no need for an adjudication method as would be used for image interpretation, for example.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. This is not an AI/ML device designed for human interpretation assistance. Therefore, an MRMC study is not relevant to this submission.

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

• No. This is not an AI/ML device. "Standalone performance" in this context would refer to the physical and electrical characteristics of the electrodes themselves, which were indeed tested (e.g., impedance, biocompatibility).

7. The Type of Ground Truth Used

• Biocompatibility Tests: The ground truth for safety (skin irritation) was established by standardized biological assays (Cytotoxicity, Dermal Sensitization, Repeat Insult Patch Test, Primary Skin Irritation Test) as outlined in the Tripartite Biocompatibility Guidance For Medical Devices. These tests have defined pass/fail criteria.
• Impedance Tests: The ground truth for effectiveness (impedance) was objective electrical measurements (driven at 1k-Hz) compared against measurements from predicate devices.

8. The Sample Size for the Training Set

• Not Applicable in the context of this device. This device is not an AI/ML system that requires a "training set" in the computational sense. The product development and validation rely on engineering design, material science, and performance testing, not AI model training.

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

• Not Applicable. As there is no "training set" for an AI/ML model, this question is not relevant to this device. The development and prior use of the RG-60 series gels in other Uni-Patch cutaneous electrodes could be thought of as a form of "prior experience" or "historical data" informing the current submission, but it's not a formal "training set" for an algorithm.

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