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

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image shows a document with the title "Image 2000" at the top. The document contains information about a user named GARCIA, DIANE M (dmp), and a folder named K042912 - 8 pages. The company is NEURO RESOURCE GROUP, INC. (NEURRESOGROU), and the product is STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF (GZJ). The summary indicates the product is INTERX5000, the date requested is Mon Jan 07 11:47:39 2008, the date printed is Mon Jan 07 11:48:16 2008, and the printer is file.

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Image /page/1/Picture/0 description: The image shows the words "Table of Contents" in a large, bold, black font. The words are arranged in a slight arc, giving the impression of a curved line. The background is plain white, which makes the text stand out.

CORRESPONDENCE - 3 pages	1
ORIGINAL - 3 pages	4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Public Health Service

MAY 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Krista Oakes Vice President, Regulatory Affairs Neuro Resource Group, Inc. 1100 Jupiter Road, Suite 190 Plano, Texas 75074

Re: K042912

Trade/Device Name: InterX5000 Regulation Numbers: 21 CFR 882.5890 Regulation Names: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: April 14, 2005 Received: April 18, 2005

Dear Ms. Oakes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Krista Oakes

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Hytl Rhodes
Miriam Provost, Ph.D.

Mirian Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) # (if known): K042912

Device Name: InterX5000

Indications for Use:

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.

Prescription Use X (21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Htp. Curda

ign-Off (Division' Division of General, Restorative. and Neurological Devices

KOYZ912 510(k) Number ___

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APPENDIX A

SUMMARY OF SAFETY AND EFFECTIVENESS

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Image /page/6/Picture/0 description: The image shows the logo for Neuro Resource Group. The logo consists of the letters "NRG" inside of a rounded rectangle. Below the logo, the words "NEURO RESOURCE GROUP" are written in block letters.

510(k) Summary

Submitter Information:

Contact:

Krista Oakes Tel: 972-438-5202 Fax: 972-401-9161

Date Prepared:

September 30, 2004

Product Name & Classification:

Classification Regulation: 882.5950, 890.5850, Panel: Neurology, Physical Medicine Product Code: GZJ, IPF Trade Name(s): InterX5000

Predicate Device:

K041575 - Fenzian Treatment System K951951 - EMPI Focus 795 K870947 - Dynatron 500 Electrical Muscle Stimulator

Description:

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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.

Intended Use:

The InterX5000 is indicated for:

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

Comparison to Predicate Devices:

. Does the new Device have the same indications for use? Yes
Does the new Device have the same Technological Characteristics? Yes l
Are Descriptive Characteristics precise enough to ensure Equivalence? Yes.
Are Performance Data available to assess Equivalence? Yes
Performance Data Demonstrate Equivalence? Yes

A comparison matrix has been provided as part of this premarket notification.

Performance Data & Conclusions:

Performance bench testing was conducted to characterize the electrical performance of the InterX5000 as compared to published data of predicate devices.

Regulation Number and Section

§ 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).