(208 days)
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
| Acceptance Criteria (General Equivalence) | Reported Device Performance (Comparison to Predicate Devices) |
|---|---|
| Same indications for use | Yes |
| Same technological characteristics | Yes |
| Descriptive characteristics precise enough to ensure equivalence | Yes |
| Performance data available to assess equivalence | Yes |
| Performance data demonstrate equivalence | Yes |
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.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).