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The ProStim Reusable Neurostimulation Electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. ProStim Reusable Neurostimulation Electrodes are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation).

ProStim Reusable Neurostimulation electrodes arc non-sterile, disposable laminated. flexible structures composed of materials commonly used in this application: First Layer-White spun laced nonwoven tape or White 1/32" thick Polyethylene foam or a polypropylene substrate, coated with biocompatible adhesive. Second Layer- Conductive plastic film. Third Layer-Biocompatible conductive hydrogel coupling media. The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The electrode has one type of connection point that can be used to connect the stimulation device to the electrodes. This connection point is compatible with all standard, marketed Neurostimulation devices. Lead wire assembly - 6" wire with .080 in. diameter female socket connected to one side of the wire.

The provided document describes the ProStim Reusable Neurostimulation Electrodes and its 510(k) summary for market clearance. The study presented focuses on demonstrating substantial equivalence to predicate devices, primarily through impedance testing and biocompatibility assessments, rather than a clinical efficacy study with human readers or outcomes data.

Here's a breakdown of the requested information based on the provided text:

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 sample size for the impedance testing or biocompatibility tests. It only states that the gels "have passed" the required tests and that impedance values "were comparable."

• Test Set Sample Size: Not explicitly stated for either biocompatibility or impedance testing in this summary.
• Data Provenance: Not explicitly stated. The biocompatibility tests refer to file numbers for the specific gels, implying these are existing test results for components rather than a new study specific to the ProStim device's final configuration. The impedance testing is described as being performed for the subject device in comparison to predicate devices, but details on where or when this was conducted are not provided.

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

Not applicable. The study did not involve human expert interpretation or ground truth establishment in the context of clinical images or diagnoses. The "ground truth" for biocompatibility is established by standardized testing protocols, and for effectiveness, it's defined by impedance measurements against predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical study with human readers requiring adjudication.

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. This device is an electrode for neurostimulation, not an AI-powered diagnostic tool. The submission is a 510(k) for substantial equivalence based on technological characteristics and safety/effectiveness data, not a clinical efficacy study involving human readers.

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

Yes, in a conceptual sense. The "performance" of the device was assessed on its intrinsic characteristics (biocompatibility and electrical impedance) without human intervention in the measurement of these characteristics, or human interpretation as part of a diagnostic workflow. The device itself is a component in a system where a human typically applies it and uses it with an electrical stimulator.

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

• For Biocompatibility: The "ground truth" was established by the results of standardized in vitro and in vivo tests for cytotoxicity, sensitization, and primary skin irritation as specified by the "Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 requirements for skin contact."
• For Effectiveness (Impedance): The "ground truth" was indirectly established by the electrical impedance values of legally marketed predicate devices. The acceptance criterion was that the subject device's impedance values were "comparable" to these predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning sense. The safety and effectiveness data were generated through specific tests and comparisons to predicate devices, not through a learning phase.

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

Not applicable, as no training set was used.

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SOF-PACH™ Reusable Cutaneous Neurostimulation Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. SOF-PACH™ Reusable Electrodes are designed and intended to be used with marketed. Electrical Stimulators i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) of PGF (Pulsed Galvanic Stimulation).

These electrodes will include the precaution statement: Federal Law restricts the device to sale by or on the order of a licensed practitioner or therapist.

SOF-PACH™ Reusable Neurostimulation Electrodes are non-sterile laminated, flexible structures composed of materials commonly used in this application:

First layer - Various cloths, tapes, etc. including Tricot/polyester fabric, polyethylene foam or a polypropylene substrate, coated with biocompatible adhesive.

Second layer Electrically conductive carbon coated with or without Ag/AgCl, and Activated Carbon Mesh material.

Third layer Biocompatible conductive hydrogel coupling media (CATHAY's Gel) which has passed the required skin sensitivity testing criteria as specified in the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 requirements for skin contact. These tests include Cytotoxicity, Sensitization and Primary Skin Irritation Tests.

The electrodes are designed for single-patient/multiple application use. They have a low profile construction designed for comfort under clothing and utilize tan-tone fabric for reduced visibility. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The electrodes have two different types of contact points that can be used to link the stimulation device to the electrodes. These contact points are compatible with standard marketed Neurostimulation devices.

1. Lead wire assembly 6" wire with .080 inch diameter recessed female socket connected to one side of the wire. The lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR Part 898
2. Male snap assembly Two-part sensor and stud mated together.

This document is a 510(k) summary for the SOF-PACH™ Reusable Neurostimulation Electrodes (K020735). It describes the device, its technological characteristics, and how its safety and effectiveness were established by comparison to predicate devices.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "CATHAY's Gel has passed the required skin sensitivity testing criteria" and "point-to-point impedance testing for all manufacturers' electrodes (including SOF-PACH™) ranged from 125-250 ohms". However, the specific sample sizes for these tests (both for the gel biocompatibility and the impedance testing) are not explicitly stated in the provided text.

Data Provenance: The document does not specify countries of origin for the test data. The biocompatibility tests are likely conducted in a lab setting, and impedance tests on the devices themselves. There is no indication of retrospective or prospective patient data, as the tests are on the device itself and its components, not involving human subjects in a clinical trial for effectiveness.

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

This type of information is not applicable to this 510(k) submission. The "ground truth" for this device's acceptance criteria relies on standardized material testing (biocompatibility) and direct physical measurement (electrical impedance), not on expert clinical interpretation of data.

4. Adjudication Method for the Test Set

This is not applicable. As mentioned above, the acceptance criteria are based on standardized tests and direct measurements, not on subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is a neurostimulation electrode, and its safety and effectiveness are established through testing its physical and material properties, and comparison to predicate devices' stated characteristics, not through analyzing human reader performance with or without AI assistance.

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

No, a standalone algorithm performance study was not done. This device is a physical medical device, not an AI or software algorithm.

7. The Type of Ground Truth Used

The ground truth for the safety criteria (skin irritation/sensitivity) was established by passing standardized biocompatibility tests (Cytotoxicity, Sensitization, and Primary Skin Irritation Tests) as specified in the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1.

The ground truth for the effectiveness criteria (impedance) was established by direct electrical measurement using a standard voltmeter (point-to-point impedance at 1 K-Hz). The acceptance was based on comparability to predicate devices.

8. The Sample Size for the Training Set

This is not applicable. This submission describes a physical medical device, not an algorithm that requires a training set. The device itself is manufactured, and its components and final product are tested.

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

This is not applicable as there is no training set for this type of device submission.

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