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The NeuroMetrix SENSUS Electrode is intended for use as disposable, conductive, adhesive interface between the patient's skin and a transcutaneous electrical nerve stimulator.

The SENSUS Electrode provides an electrically conductive interface between a transcutaneous electrical nerve stimulator and a patient's skin. It is provided non-sterile, is designed and intended for single patient use only, and to be disposable.

The SENSUS Electrode is comprised of four individual electrodes, each of size 36 by 46 mm. The overall dimensions are 50 by 280 mm. The individual electrodes are electrically connected in pairs such that the two outer electrodes constitute one pair and the two inner electrodes constitute a second pair. The SENSUS Electrode contains two conventional male snap connectors for electrical connection to a transcutaneous electrical nerve stimulator.

The SENSUS Electrode has a multi-layer design. The first and outermost layer is a sheet of Mylar. The second layer contains conductive silver traces and silver electrode pads. Where the silver traces are not covered by hydrogel, they are covered by a dielectric mask. The third layer is the four individual electrodes which consist of a medical grade, self adhering, biocompatible hydrogel (KM-10G, Katecho, Inc., Des Moines, IA). When not in use, the hydrogel is covered by a Mylar release liner. Two male type snap connectors interface the SENSUS Electrode to the transcutaneous electrical nerve stimulator. The patient facing surface of the snap connectors are either under hydrogel or covered by a laminated dielectric polypropylene layer. Therefore in both cases the snap connectors do not directly contact the patient's skin.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, 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 provide explicit sample sizes for the non-clinical tests (electrical, mechanical, biocompatibility). It states that NeuroMetrix determined that non-clinical (i.e., bench) testing was sufficient.

Regarding data provenance:

• Biocompatibility: The biocompatibility data is derived from related hydrogel formulations (KM-10B and KM-10P) from Katecho, Inc., which were previously cleared (K000870). This suggests a retrospective use of existing data from the hydrogel manufacturer.
• Electrical and Mechanical Testing: These appear to be prospective bench tests conducted on the SENSUS Electrode itself. The country of origin for this data is not specified, but the sponsor is NeuroMetrix, Inc. in Waltham, MA, USA, suggesting the testing was likely conducted in the USA or by a contract lab.

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

This information is not applicable as the SENSUS Electrode is a device and its performance is evaluated through objective physical and electrical measurements, not by expert interpretation of images or signals. Therefore, there is no "ground truth" established by experts in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation relies on objective measurements and comparison to standards, not human interpretation that would require 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 type of study is relevant for diagnostic AI systems where human readers interpret medical data. The SENSUS Electrode is a physical medical device (an electrode), not a diagnostic AI system, so this type of study is not applicable.

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

This question is not applicable as the SENSUS Electrode is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Objective physical and electrical measurements: Such as impedance, current dispersion, adhesive strength, connection resistance, and retention force, compared against predefined target specifications.
• Compliance with recognized standards: ISO 10993-5:2009 (cytotoxicity) and ISO 10993-10:2010 (irritation and skin sensitization).
• Existing biocompatibility data: For the hydrogel, established by the manufacturer (Katecho, Inc.) through testing of related formulations.
• Substantial equivalence: To the predicate device, based on comparable intended use, materials, and technological characteristics.

8. The Sample Size for the Training Set

This information is not applicable as the SENSUS Electrode is a physical medical device and does not involve AI or machine learning models that require a training set.

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

This information is not applicable for the same reasons as #8.

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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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