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ISSDE is indicated for use with InterX Transcutaneous Electrical Nerve Stimulator. The ISSDE provides the conductive interface between the InterX stimulation device and the patient's skin. The ISSDE is not made with natural rubber latex, is reusable (single patient only), and is provided packaged and labeled as a sterile device, for single patient use. As a sterile device, the ISSDE can be applied to patients in a sterile post-operative healthcare setting. NRG only guarantees sterility for the first application, however, ISSDE can be repositioned and reapplied (single patient only) as a non-sterile device for subsequent applications. Refer to the labeling for reuse instructions.

The Proposed ISSDE is a flexible, sterile laminate composed of a top cover, a reinforcement film, dual conductive members with printed silver, biocompatible conductive hydrogel, a release liner which protects the hydrogel before use and during storage and a 2-conductor cable secured between the reinforcement film and the conductive members. The electrodes do not contain active electronics, software or firmware. The cable connects the dual-electrode to the Inter X electrical stimulation device. A single finished dual-electrode is placed into a protective pouch which is then sealed, gamma sterilized and boxed for shipment. The Proposed ISSDE is designed for single-patient/multiple application use.

The provided text describes the InterX Sterile Self-Adhesive Dual Electrode (ISSDE) and its performance against acceptance criteria, primarily through comparison to predicate devices, in the context of a 510(k) submission.

Here's an analysis of the acceptance criteria and study information:

1. Table of acceptance criteria and the reported device performance

The document presents a "Substantial Equivalence Table" comparing the ISSDE to three predicate devices for various characteristics, which effectively serves as the acceptance criteria and the reported performance. The "acceptance criteria" for the ISSDE are implicitly defined by its substantial equivalence to the predicate devices and compliance with relevant standards.

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 refers to "samples per electrode type" for impedance testing, but it does not specify the exact sample size number used for the test set for any of the performance tests (impedance, energy distribution, biocompatibility, adhesion, etc.).

The data provenance is from bench testing conducted by the manufacturer (Neuro Resource Group, Inc.) in the context of a 510(k) submission, confirming design verification. There is no mention of country of origin of the data or whether it was retrospective or prospective in the clinical sense, as the testing is purely on the device's physical and electrical characteristics.

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

This question is not applicable to this type of device and study. The "ground truth" here is objective physical and electrical measurements of the device's performance, compared against established engineering standards and predicate device performance. It does not involve expert interpretation or clinical assessment by medical professionals like radiologists.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., image reading) where consensus among multiple reviewers is needed to establish ground truth. The tests described are objective measurements (e.g., impedance, adhesive strength) that do not require human adjudication to determine a "truth."

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 question is not applicable as the device is a cutaneous electrode, not an AI-assisted diagnostic tool or an imaging modality that would involve human readers or AI assistance.

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

This question is not applicable. The device is a passive electrode and does not contain an algorithm. The "performance" described is the electrode's physical and electrical properties, not an algorithm's output.

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

The "ground truth" used for this device is based on:

• Established engineering standards: e.g., ISO standards (ISO 10993 for biocompatibility, ISO 11137 for sterilization) and FDA guidance for cutaneous electrodes.
• Physical and electrical measurements: Directly measuring properties like impedance, adhesion, and energy distribution.
• Performance of legally marketed predicate devices: The ISSDE's performance is compared against the pre-established characteristics of three predicate electrodes for "substantial equivalence."

8. The sample size for the training set

This question is not applicable. The device is a passive medical device (an electrode), not a machine learning or AI model that requires a "training set."

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

This question is not applicable for the same reason as point 8.

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This device is intended for cosmetic use.

The InterX 1000/Derma 200 Stimulator for Cosmetic Use is a hand-held, battery operated device consisting of a main operating unit (InterX 1000) and an external electrode (Derma 200).

The provided text does not contain detailed acceptance criteria or a study that specifically proves the InterX 1000/Derma 200 Stimulator for Cosmetic Use meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or reader improvement.

However, based on the available information, here's what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

Study Information (Based on interpretation of "Performance Testing" mentioned):

The document broadly mentions "Bench and clinical testing were conducted to demonstrate performance for the device's intended use." However, it does not provide any specific details about these tests in terms of methodology, results, or quantitative metrics.

Therefore, for the following points, the information is not available in the provided text.

2. Sample size used for the test set and the data provenance: Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.

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 provided. This device is an electrical stimulator for cosmetic use, not an AI-powered diagnostic tool, so an MRMC study with human readers assisting AI or vice-versa is not applicable in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (electrical stimulator) rather than an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided. Given its intended "cosmetic use," ground truth might relate to aesthetic improvements, but no details are given.

8. The sample size for the training set: Not applicable and not provided. This device is not an AI/machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established: Not applicable and not provided.

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The InterX500 Flexible Array Electrode is intended to be used with authorized InterX TENS and/or Powered Muscle Stimulator devices for the purpose of applying electrical stimulation.

The InterX500 Flexible Array Electrode consists of stainless steel electrodes assembled in a biomedical grade silicone rubber. The electrodes are connected to each other by wiring through a connector cable. There is no power to the InterX500 Flexible Array Electrode unless it is connected to interactive electrostimulation device provided by Neuro Resource Group, Inc. The InterX500 Flexible Array Electrode is placed directly onto unbroken skin and does not use any conductive gels. The connector is medically recognized and cannot be plugged into an AC socket. The InterX500 Flexible Array Electrode is an optional external electrode accessory for an interactive electrostimulation device provided by Neuro Resource Group. The electrode serves as an extension to the device to allow the user to apply treatment in larger and less accessible areas by the electrodes on the interactive electrostimulation device. The InterX500 Flexible Array Electrode is intended to be used with a Neuro Resource Group, Inc. provided electrostimulation device and does not contain any active electrical components. The cable is a two conductor cable using two 24 AWG single wires tinned with copper. The cable is UL and CSA approved.

The provided text is a 510(k) summary for a medical device called the "InterX500 Flexible Array Electrode." It describes the device, its intended use, and its classification, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested table and study details. This document is a regulatory submission for substantial equivalence, not a performance study report.

Here's what the document does contain or imply:

• Device Name: InterX500 Flexible Array Electrode
• Intended Use/Indications for Use: "The InterX500 Flexible Array Electrode is intended to be used with authorized InterX TENS and/or Powered Muscle Stimulator devices for the purpose of applying electrical stimulation."
• Predicate Device: K042912 - InterX 5000
• Classification Regulation: 21 CFR 882.1320 (Electroencephalograph – but this seems to be a misclassification as the device is for electrical stimulation, not EEG. The product code GXY is for "Electrode, Patient, Intracavitary, Therapeutic, Stimulating" so the regulation number might be a typo in the FDA letter.)
• Regulatory Class: II

The document focuses on establishing substantial equivalence to a predicate device, which primarily relies on demonstrating similar technological characteristics and intended use, and often includes safety testing (e.g., biocompatibility, electrical safety) but not necessarily advanced performance metrics in a clinical study context.

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The InterX5000 is indicated for symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain.

The InterX5000 is indicated for:

• symptomatic relief and management of chronic, intractable pain
• adjunctive treatment in the management of post-surgical and post-traumatic pain
• relaxing muscle spasms
• increasing local blood circulation
• immediate post surgical stimulation of calf muscles to prevent venous thrombosis
• muscle reeducation
• maintaining or increasing range of motion
• preventing or retarding disuse atrophy

InterX means "Interactive". InterX technology is designed to work by introducing very brief pulses of electricity into the tissue and immediately monitoring impedance changes as the tissue responds. Stimulation and sensing take place via a concentric electrode system that is moved over the skin surface, and a digital display enables the operator to follow the course of the treatments and adjust the output.

The InterX 5000 consists of a small handheld device in a plastic case. It is powered by one nine-volt alkaline battery. On the upper face of the machine there are two LED's, an LCD display and 5 control buttons. The underside of the machine two metal surfaces that form the poles of a treatment electrodes are placed directly on the unbroken skin and do not use any conductive material or gel.

On the side of the machine is one socket for a standard 3.5mm stereo jack socket that connects to the main electrodes of the machine to an optional external electrode accessory. The device's electrodes are disabled when the optional external electrode accessory is attached. The optional external electrode accessories only serve as an extension and allow the user to apply treatment in a areas which may not be accessible by the main unit electrodes. user to apply ucannell in a accessories intended for use with the InterX 5000 have any active electrical components.

The waveform is a high amplitude, short-duration bi-polar pulse (circuitry in the device integrates time and dosage delivered). A digital display monitors the biofeedback process in mtegrates thire and dosage convolling the operator to track changes in the tissues being treated and make appropriate adjustments to the output characteristics if necessary. This interaction and human adjustment continues throughout the length of the InterX treatment. The result is that the body experiences a conditioned training process that enhances the body's ability to effectively reduce and manage the level of pain.

The provided document is a 510(k) summary for the InterX5000 device, a transcutaneous electrical nerve stimulator. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information about acceptance criteria, study details, expert involvement, and ground truth establishment is not present in this document.

However, I can extract the relevant information that is available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable. The document describes performance bench testing, not a clinical study with human subjects or a test set in the traditional sense for evaluating AI performance. The "test set" here refers to the electrical performance of the device itself.
• The data provenance is internal testing performed by the manufacturer, Neuro Resource Group, Inc.

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

• Not applicable. Ground truth as typically defined for clinical effectiveness studies is not relevant here. The "ground truth" for the electrical performance would be established by engineering and electrical standards.

4. Adjudication method for the test set:

• Not applicable. No human adjudication is mentioned for the electrical performance bench testing.

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, a MRMC comparative effectiveness study was not done. The device is a nerve stimulator, not an AI-assisted diagnostic tool for human readers.

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

• The device itself operates as a standalone transcutaneous electrical nerve stimulator. The performance data presented (electrical performance bench testing) is for the algorithm (circuitry that integrates time and dosage) and device hardware operating in isolation from a human interpretation loop.

7. The type of ground truth used:

• For the performance data, the "ground truth" would be the established electrical and engineering specifications and performance benchmarks for similar devices, to which the InterX5000's electrical performance was compared.

8. The sample size for the training set:

• Not applicable. There is no mention of a training set as this is not an AI/machine learning study requiring such.

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

• Not applicable. No training set is mentioned.

Summary of available information:

The document describes performance bench testing conducted to characterize the electrical performance of the InterX5000 compared to published data of predicate devices (K041575 - Fenzian Treatment System, K951951 - EMPI Focus 795, K870947 - Dynatron 500 Electrical Muscle Stimulator). This testing confirmed the device's electrical characteristics were substantially equivalent to those of the predicate devices. The "acceptance criteria" were implied by the points of comparison for substantial equivalence. The study details, as requested in points 2-5, 8, and 9, are typical for clinical performance studies, which are not detailed in this 510(k) summary for a nerve stimulator's substantial equivalence to predicates. The "ground truth" (point 7) for this type of submission focuses on electrical characteristics matching established specifications and predicate performance.

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