The TENS is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post surgical and post traumatic acute pain

Device Description

The Fast Start® TENS device is a transcutaneous electrical nerve stimulator that provides a non-invasive, drug free method of controlling acute and principally long term intractable pain. The device projects mild electrical impulses that are transmuted through the skin via surface electrodes to modify the body's pain perception. The FastStart ® TENS is made up of the device, one 9 V alkaline battery, a set of electrodes, two lead wires, and a carrying case.

AI/ML Overview

The provided text is a 510(k) summary for the "Fast Start® TENS" device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and reported device performance in the way a clinical trial or algorithm validation study would.

Therefore, many of the requested sections (sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set details) are not applicable or not available in this type of submission.

Here's a breakdown of what can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided 510(k) summary. The submission's core argument is about substantial equivalence to a predicate device, implying that its performance is acceptable if it functions similarly to the already approved predicate. No specific performance metrics or acceptance thresholds are detailed.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. This 510(k) summary does not describe a clinical study or a separate performance evaluation with a "test set" in the context of device performance against specific metrics. It relies on the similarities to the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided. The submission does not describe a process of establishing ground truth with experts for a test set.

4. Adjudication Method for the Test Set

This information is 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

This information is not applicable/not provided. This device (Transcutaneous Electrical Nerve Stimulator) is a physical medical device, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is irrelevant to its approval.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable/not provided. As explained above, this is a physical device, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable/not provided. The submission argues for substantial equivalence based on technical characteristics and indications for use, not by comparing performance against a "ground truth" derived from patient outcomes or expert consensus.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a hardware product, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided.

Summary of the Study and Device Acceptance (Based on K041092 Document):

The "study" in this context is the 510(k) premarket notification process itself, which aims to demonstrate that the new device is "substantially equivalent" to an already legally marketed device (the predicate device). Approval is based on meeting this substantial equivalence rather than explicit, new acceptance criteria and a performance study against those criteria.

Acceptance Criteria (Implied): The primary "acceptance criterion" is that the new device (Fast Start® TENS) is substantially equivalent to the predicate device (Classic TENSTM, K020437) in terms of indications for use, technical characteristics, and device specifications. This means it should not raise any new questions regarding safety and effectiveness.
Study That Proves Substantial Equivalence: The submission itself constitutes the "study." It does not present a clinical trial or performance data in the traditional sense. Instead, it makes a reasoned argument by:
- Comparing Indications for Use: The Fast Start® TENS has the same indications for use as the Classic TENS: "symptomatic relief and management of chronic intractable pain, and/or as an adjunctive treatment in the management of post surgical and post traumatic acute pain."
- Comparing Technical Characteristics and Device Specifications: The document states that "This device is similar to its predicate device, the Classic TENS, they both exhibit the same indications for use, technical characteristics and device specifications." It further mentions the Fast Start® TENS has "three modes of operation: Conventional, Burst, and Modulated" and "twelve pre-set and two customized programs," implying these are comparable or represent standard TENS functionalities also found in the predicate or are generally accepted.
- Conclusion: The submission concludes that "Designed with the same performance standards as its predicate, the Fast Start ® TENS does not raise any new questions in regards to safety and effectiveness. The device contains three modes of operation... It is also equipped with twelve pre-set and two customized programs. The Fast Start TENS meets the mandatory performance standards."

In essence, the "proof" for this 510(k) is the detailed comparison to an already approved device, asserting that the new device is functionally and technically similar enough not to warrant new, extensive performance testing.

Summary

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Koy1092

510 (k) SUMMARY

JUL 01 2004

Statement:	This summary of 510(k) substantial equivalence isbeing submitted in accordance with therequirements of 21 CFR 807.92 and can be used toprovide a substantial equivalence summary toanyone requesting it from the Agency.
Submitter's Identification:	Vision Quest Industries, Inc.18011 Mitchell SouthIrvine, CA 92614Contact Person: Jaime Pulley, VP of QualityAssurance/Regulatory AffairsPhone: (949) 794-3865Fax: (949) 477-9672
Date Summary Prepared:	April 21, 2004
Name of Device:	Proprietary Name: Fast Start® TENSCommon Name: (TENS) Transcutaneous ElectricalNerve Stimulator
Classification Name:	Stimulator, Nerve, Transcutaneous, for pain relief(GZJ)
Predicate Device Name:	Classic TENSTM510(k) Number K020437Mantra International Ltd.Room L-5 15/F Blk B, Vigor IndustrialBuilding. 20 Cheung Tai RoadTsing Yi, Hong Kong

Device Description:

Indications for Use

The TENS is used for symptomatic relief and management of chronic intractable pain,

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510(k) Summary (continued)

and/or as an adjunctive treatment in the management of post surgical and post traumatic acute pain.

Comparison to Predicate

This device is similar to its predicate device, the Classic TENS, they both exhibit the same indications for use, technical characteristics and device specifications.

Conclusion

Designed with the same performance standards as its predicate, the Fast Start ® TENS does not raise any new questions in regards to safety and effectiveness. The device contains three modes of operation: Conventional, Burst, and Modulated. It is also equipped with twelve pre-set and two customized programs. The Fast Start TENS meets the mandatory performance standards.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

JUL 0 1 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jaime X. Pulley Vice President of Quality Assurance and Regulatory Affairs VisionOuest Industries. Inc. 18011 Mitchell South Irvine, California 92614

Re: K041092

Trade/Device Name: FastStart® TENS, Model FS 3001 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: April 21, 2004 Received: April 26, 2004

Dear Mr. Pulley:

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 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 -- Jaime X. Pulley

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 (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 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 yours.

Miriam C. Provost

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): K041092

Device Name: __ Fast Start TENS

Indications For Use:

The TENS is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post surgical and post traumatic acute pain

Prescription Use X (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)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number_ K04/092

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).