The neurotech BACKTENS device is intended to provide to pain associated with sore and The neurotech BACKTENS device is intentiou to provins time sump and the program and in activities

Device Description

The NeuroTech BackTENS device is a self-contained battery operated transcutaneous electrical muscle stimulator. The adhesive electrodes are mounted on a belt offering lumbar support to the user during therapy delivery. The device is intended to provide a non-invasive therapy for over the counter sale.

AI/ML Overview

The provided text describes a 510(k) summary for the NeuroTech® BackTENS & Lumbar support Type 294 device. However, it does not contain any information about acceptance criteria or a study designed to prove the device meets specific performance metrics for clinical efficacy or accuracy in the way described in the prompt.

Instead, the document focuses on:

Substantial Equivalence: The primary goal of this 510(k) submission is to demonstrate that the NeuroTech BackTENS device is substantially equivalent to a legally marketed predicate device (NeuroTech© Smart-TENS, Type 456, K961376).
Safety and Performance to Standards: The device's safety and performance are assessed against existing, recognized electrical safety and electromagnetic compatibility (EMC) standards (e.g., IEC 60601-1, IEC 60601-2-10, IEC 601-1-1, IEC 601-1-2, IEC 61000-4-2, IEC 61000-4-3, DD ENV 50204, EN 55011). It also mentions hazard, risk, and failure mode effects analyses.
Electrical Output Comparison: Non-clinical tests involved comparing the electrical outputs of the new device to the predicate device, showing similar results.
Intended Use: The device is indicated for transcutaneous electrical nerve stimulation (TENS) for symptomatic relief and management of chronic lower back pain, and for lumbar support.

Therefore, I cannot populate the table or answer most of the questions as the required information (acceptance criteria, performance data, clinical study details, ground truth, expert opinions, sample sizes for testing/training sets, MRMC study, standalone performance) is not present in the provided text.

The document details the regulatory process (510(k) submission, FDA review, substantial equivalence determination) rather than the results of an empirical study with performance metrics.

Here's an attempt to address the prompt based only on the available information, with the understanding that most sections will be marked as "Not Provided" or "Not Applicable" for a traditional device performance study.

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Clinical Efficacy/Accuracy for TENS	Not Provided (No clinical performance criteria or results are mentioned for efficacy in pain relief or accuracy metrics)
Electrical Output (compared to predicate)	Similar results to predicate (NeuroTech© Smart-TENS)
Compliance with Safety Standards	Designed and independently tested to: - IEC 60601-1:1990 - IEC 60601-2-10 - IEC 601-1-1 (A1:1991, A2:1995)
Compliance with EMC Standards	Designed and independently tested to: - IEC 601-1-2 - IEC 61000-4-2:1995 - IEC 61000-4-3:1997 - DD ENV 50204:1996 - EN 55011:1998
Hazard, Risk, FMEA	Hazard analysis, risk analysis, and failure mode effects analysis have been carried out.
Final Performance Testing	All devices are subject to final performance testing (industry practice).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Test Set): Not provided. The document describes "non-clinical tests" comparing electrical outputs, but no specific sample size for device units tested or patients is mentioned.
Data Provenance: Not provided, beyond the manufacturer being Bio-Medical Research Ltd in Galway, Republic of Ireland. The tests mentioned are likely in-house or by independent testing labs for electrical/EMC compliance, not clinical data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable/Not Provided: The document does not describe a clinical test set requiring expert-established ground truth. The "tests" mentioned are primarily electrical and safety compliance.

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

Not Applicable/Not Provided: There is no clinical test set described 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: This is a TENS device, not an AI or diagnostic imaging device. An MRMC study is not relevant to the information provided.

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

Not Applicable: This is a physical medical device (TENS stimulator), not an algorithm or AI. Standalone algorithmic performance is not relevant.

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

Not Applicable/Not Provided: For the electrical and safety tests, the "ground truth" would be the specified parameters in the standards and the electrical output of the predicate device. No clinical ground truth method is discussed.

8. The sample size for the training set

Not Applicable: This is a physical medical device; there is no "training set" in the context of machine learning or algorithms.

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

Not Applicable: As above, there is no training set mentioned or implied.

Summary of what the document does convey regarding device acceptance:

The NeuroTech BackTENS device was accepted by the FDA based on the demonstration of substantial equivalence to an existing predicate device (NeuroTech© Smart-TENS). This equivalence was supported by:

Similar intended use.
Comparable technological characteristics (e.g., delivery of stimulation signal, parameter settings, LCD screen, user compliance logging).
Non-clinical tests showing similar electrical outputs between the two devices.
Compliance with recognized national and international electrical safety and electromagnetic compatibility (EMC) standards (e.g., IEC 60601-1, IEC 601-1-2).
Completion of risk management activities (hazard analysis, risk analysis, FMEA).

The acceptance criteria were therefore focused on meeting the requirements for substantial equivalence and demonstrating adherence to established safety and performance standards for transcutaneous electrical nerve stimulators, rather than an independent clinical efficacy study with specific performance metrics.

Summary

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K023916

Page 1 of 2 510(k) Summary

APR 1 5 2004

Bio-Medical Research Ltd Parkmore Business Park, West Galway Ireland

1	-
August of the careerI	-11

510 (k) Summary of Safety and Effectiveness.
This summary is submitted in accordance with 21 CFR 807.92
a)	1	Submitted by	Bio-Medical Research LtdBMR HouseParkmore Business Park, WestGalwayRepublic of Ireland
Establishment Registration Number			8020867
Contact Person			Michelle Sawyer
Phone			+353 91 774361
Fax			+353 91 773302
e-mail			msawyer@des.bmr.ie
Title			Regulatory Affairs Manager
Date of Preparation			November 2002.
2		Trade Name of Device	NeuroTech© BackTENS & Lumbar support Type 294.
Common Name			NeuroTech© BackTENS & Lumbar support.
Classification name			Transcutaneous Electrical Nerve Stimulator.(882.5810)
3		Identification of predicate device	NeuroTech© Smart-TENS , Type 456, Clearance ref# K961376.

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Description of Device 4

The device is intended to provide a non-invasive therapy for over the counter sale.

Intended Use ട

The device is indicated for:

· Transcutaneous Electrical Nerve Stimulation (TENS), which provides the symptomatic relief and management of chronic lower back pain.
· Lumbar support.

Technological Comparison ട

The NeuroTech BackTENS is similar to the Smart-TENS in it's delivery of the stimulation signal and has similar parameter settings. Both products utilise a LCD screen with user compliance logging.

Non- clinical Tests 7

Comparisons of electrical outputs for the two devices show similar results. They have both been designed and independently tested to the following requirements;

IEC 60601-1:1990 Medical electrical equipment Part 1: General requirements for . safety.
. IEC 60601-2-10
IEC 601-1-1 and appendices A1:1991,A2:1995 . IEC 601-1-2: EMC requirements
IEC 61000-4-2:1995: Electromagnetic compatibility .
IEC 61000-4-3:1997: Electromagnetic compatibility .
DD ENV 50204:1996: Electromagnetic compatibility .
EN 55011:1998: radiated emissions. .

Bio-Medical Research Ltd, (BMR), adheres to recognised and established industry practice, and all devices are subject to final performance testing.

A hazard analysis, a risk analysis and a failure mode effects analysis have been carried out for the device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol consisting of three curved lines, resembling a caduceus or a representation of human services. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 5 2004

Carol O'Donnell, Ph.D. Clinical and Regulatory Affairs Manager Bio-Medical Research Limited BMR House Parkmore Business Park West Galway Ireland

Re: K023916

Trade Name: NeuroTech® Back TENS and Lumbar Support, Type 294 Regulation Number: 21 CFR 882.5890, 21 CFR 882.1320, and 21 CFR 890.3490 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief, Cutaneous electrode, and Truncal orthosis

Regulatory Class: II Product Code: GZJ, GXY, and IQE Dated: January 8, 2004 Received: January 16, 2004

Dear Dr. O'Donnell:

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 does not mean that FDA has made a determination that your device complics 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 - Carol O'Donnell, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and w your finding of substantial equivalence of your device to a legally prematted 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 (301) 594-4659. 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 may be obtained 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/dsma/dsmamain.html

Sincerely vours,

Sincerely yours,

Mark A. Mcllussen

Celia M. Witten, Ph.D., M.D. 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) Number (if known):K023916

neurotech BACKTENS & Lumbar Support Device, type 294 Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The neurotech BACKTENS device is intended to provide to pain associated with sore and The neurotech BACKTENS device is intentiou to provins time sump and the program and in activities

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Milham

eral, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K023916

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).