The Smart-TENS is a compact, battery powered transcutaneous electrical nerve stimulator. It is used for the relief of chronic intractable pain by providing transcutaneous electrical pulses to areas of the body that require therapy for the indicated medical conditions. The parameters of the programs in the Smart-TENS cannot be set by the user. Two channels are available on the Smart-TENS. Each channel operates independently and if desired they may be used simultaneously. The clinician may set the prescribed program from a list of defined programs. The patient may then use this program or another available program called MultiTens which provides a pattern of sequences which allows variation and modulation on the stimulation pulse. The patient may also initiate burst mode on certain programs, cause one of the pattern of sequences in MultiTens Mode to repeat continuously, advance to the next sequence or pause the treatment session, increase or decrease the amplitude intensity of the stimulation or lock the intensity controls. Use of the device is recorded internally, allowing the clinician to determine compliance with the prescribed treatment regimen.

AI/ML Overview

This document describes a 510(k) Notification for the "Smart-TENS" device. It is a TENS (Transcutaneous Electrical Nerve Stimulator) device intended for the relief of chronic intractable pain.

Here's an analysis of the provided text in relation to your questions:

1. Table of acceptance criteria and the reported device performance

Based on the provided text, the acceptance criteria and performance are focused on electrical output and safety standards, rather than clinical efficacy measured by specific pain relief metrics.

Acceptance Criteria / Performance Aspect	Reported Device Performance
Stimulation Output Comparison	Comparisons of stimulation outputs for the Smart-TENS and the predicate Bio Tens Model: ST-601 show similar results that are suitable for TENS.
Electrical Safety Standards	Designed to conform to EN60601-1 (IEC 601-1).
Electromagnetic Compatibility (EMC)	Conforms to EN 60601-1-2 (IEC 601-1-2).
General Safety and Performance	Bio-Medical Research adheres to recognized and established industry practice and all devices are subject to final performance testing. The device is safe, provides appropriate stimulation output for effective relief of chronic pain, and performs as well as or better than the legally marketed predicate device.

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

Sample size for test set: Not applicable for clinical testing. For non-clinical tests, it's not specified beyond "Comparisons of stimulation outputs for the Smart-TENS and the predicate Bio Tens Model: ST-601." This implies a comparison of the device's electrical characteristics to the predicate device.
Data provenance: Not explicitly stated as retrospective or prospective for the non-clinical tests. The company location is Republic of Ireland.

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

Not applicable. No clinical testing was performed, and the "ground truth" for electrical characteristics would be established by engineering standards and measurements, not expert consensus.

4. Adjudication method for the test set

Not applicable. No clinical testing with human subjects or expert review was conducted.

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 MRMC comparative effectiveness study was done. This is a TENS device, not an AI-powered diagnostic tool, and no clinical studies involving human readers or AI assistance were performed.

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

This question is not applicable to the Smart-TENS device. It is not an algorithm-only device; it's a physical medical device for electrical stimulation.

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

For the non-clinical tests, the "ground truth" was based on:

Electrical measurement standards: Conformance to EN60601-1 and EN 60601-1-2.
Comparison to predicate device's output: Ensuring similar and suitable stimulation output.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. There was no training set.

Summary

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1613710 510(k) Notification for Smart-TENS: Appendix IX SEP 1 2 1996

510(k) Summary of Safety and Effectiveness

This summary is submitted in compliance with the FDA interim rule 21 CFR 807.92.

Bio-Medical Research Ltd., (1) Submitted by: (a) BMR House, 16 Merchants Road, Galway. Republic of Ireland Telephone: + 353 91 566911 + 353 91 566907 Fax:: Isaac Finnegan Contact Person: Design Engineer - Regulatory Affairs Position/ Title: Date of preparation: 4 April, 1996 (2) Trade name of device: Smart-TENS, Model 456 TENS Common name: Transcutaneous Electrical Nerve Stimulator Classification name: for pain relief; $882.5890 Identification of predicate (3) Bio Tens Model: ST-601 or legally marketed device: (Skylark Device Co. Ltd., 510(k) # K912178)

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510(k) Notification for Smart-TENS: Appendix IX

Description of device: (4)

(ട) Intended uses:
The Smart-TENS is used for transcutaneous electrical nerve stimulation for the purposes of relief of chronic intractable pain.

These uses are similar to the predicate marketed device identified in section (3) of this summary.

((8) Technological comparison
The Smart-TENS is similar the Bio Tens Model: ST-601 in that both are portable, compact battery powered TENS devices. Output for either device is suitable for the relief of chronic pain using standard skin surface electrodes. Both devices are similar in basic operational design and use the impedance of the output transformer to achieve a near net zero charge into the skin. The Smart-TENS is effectively a more user controllable device which indicates patient compliance.

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510(k) Notification for Smart-TENS: Appendix IX

(b) (1) Non-clinical tests:

Comparisons of stimulation outputs for the Smart-TENS and the predicate Bio Tens Model: ST-601 show similar results that are suitable for TENS. To minimize potential electrical and mechanical hazards, Bio-Medical Research adheres to recognised and established industry practice and all devices are subject to final performance testing. The Smart-TENS is designed to conform to EN60601-1 (IEC 601-1) and conforms to EN 60601-1-2 (IEC 601-1-2).

(2) Clinical tests:
No clinical testing was performed.
(3) Test conclusions:
Testing of the stimulation output parameters of the Smart-TENS indicate that the device is safe, that it provides appropriate stimulation output for effective relief of chronic pain and that it performs as well as or better than the legally marketed predicate device identified in section (3) of this Summary.

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).