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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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