Relaxation of muscle spasms .
Prevention or retardation of disuse atrophy ●
Increases local blood circulation ●
. Promotes muscle re-education and range of motion
. Maintaining and increasing range of motion
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis .

Interferential Stimulators have one additional indication for use:

Provides symptomatic relief and management of post surgical, acute, or chronic . pain
The target population for this device is patients with chronic, acute pain syndrome, and/or recovering from orthopedic related surgery.

Device Description

The T.E.A.R. Tech3 IF/Muscle Stimulator is a combination device combining the functionality of Interferential (IF) / Neuromuscular (NMES) and High Volt Pulsed Current (HVPC) stimulators in one device which produces a mild electrical current that is transmitted via leads to electrodes placed on the skin in areas predetermined by the clinician. The device, a set of electrodes with leads, a battery pack (lithium ion rechargeable and alkaline), carrying case, and instructions for use make up the T.E.A.R. Tech3 stimulation system.

AI/ML Overview

This submission does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria.

Instead, the submission, K030507 for the T.E.A.R. Tech3, is a 510(k) Premarket Notification, which demonstrates substantial equivalence to legally marketed predicate devices. This type of submission relies on showing that the new device has the same intended use and technological characteristics as existing, approved devices, and does not raise new questions of safety or effectiveness. It does not typically involve extensive clinical trials or the establishment of new performance acceptance criteria as would be seen for novel devices.

Therefore, most of the requested information cannot be extracted from this document as it pertains to a different type of regulatory submission (e.g., a PMA or De Novo classification) that would present new performance data.

Here's what can be stated based on the provided text:

Table of Acceptance Criteria and Reported Device Performance: Not applicable. The submission asserts substantial equivalence based on technological characteristics and intended use being similar to predicate devices, rather than presenting a performance study against specific acceptance criteria.
Sample size used for the test set and the data provenance: Not applicable. No test set data or provenance is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is mentioned.
Adjudication method for the test set: Not applicable. No test set needing adjudication is mentioned.
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: Not applicable. This device is an electrical stimulator, not an AI-assisted diagnostic tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth data is presented.
The sample size for the training set: Not applicable. This is not a machine learning device, so there is no training set mentioned.
How the ground truth for the training set was established: Not applicable.

Summary of the K030507 Submission:

Acceptance Criteria and Study: The submission does not define specific acceptance criteria or present a study to demonstrate performance against such criteria. Instead, it argues for substantial equivalence to predicate devices.
Basis for Substantial Equivalence: The T.E.A.R. Tech3 is deemed substantially equivalent to the predicate devices (Surgi Stim K982388 and Jace Tri-Stim K931781) because it has the "same intended use and technological characteristics" and "no new questions of safety or effectiveness have been raised."
Technological Characteristics: The device is a combination of Interferential (IF) / Neuromuscular (NMES) and High Volt Pulsed Current (HVPC) stimulators.
Indications for Use: The shared indications include relaxation of muscle spasms, prevention of disuse atrophy, increased local blood circulation, promotion of muscle re-education and range of motion, maintaining/increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. The Interferential Stimulator has an additional indication for symptomatic relief and management of post-surgical, acute, or chronic pain.
Target Population: Patients with chronic/acute pain syndrome, and/or recovering from orthopedic-related surgery.

Summary

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K030507

MAY 2 0 2003

510(k) SUMMARY

Statement:	This summary of 510(k) substantial equivalence is beingsubmitted in accordance with the requirements of 21 CFR807.92 and can be used to provide a substantial equivalencesummary to anyone requesting it from the Agency.
Submitter's Identification:	VisionQuest Industries, Inc.18011 Mitchell SouthIrvine, CA 92614Contact Person: Alan Wade, Director, Product DevelopmentPhone: (949) 261-3000Fax: (949) 477-9672
Date Summary Prepared:	February, 12, 2003
Name of the Device:	Proprietary Name: T.E.A.R. Tech3
	Common Name: Interferential StimulatorHigh Volt Pulsed Current StimulatorNeuromuscular Electrical Stimulator
Classification Name:	Interferential Current Therapy (LIH)Stimulator, Muscle, Powered (IPF)
Predicate Device Name:	Surgi Stim510(k) Number: K982388VisionQuest Industries, Inc.,18011 Mitchell South, Irvine, CA 92614
	Jace Tri-Stim510(k) Number: K931781Thera-Kinetics DBA Jace Systems7 Carnegie Plaza, Cherry Hill, NJ 08003

Device Description:

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510(k) SUMMARY (continued)

transmitted via leads to electrodes placed on the skin in areas predetermined by the clinician. The device, a set of electrodes with leads, a battery pack (lithium ion rechargeable and alkaline), carrying case, and instructions for use make up the T.E.A.R. Tech3 stimulation system.

Indications for Use:

The High Volt Pulsed Current Stimulator and Neuromuscular Electrical Stimulators share the same indications for use as listed below:

Relaxation of muscle spasms .
Prevention or retardation of disuse atrophy ●
Increases local blood circulation ●
. Promotes muscle re-education and range of motion
. Maintaining and increasing range of motion
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis .

Interferential Stimulators have one additional indication for use:

Provides symptomatic relief and management of post surgical, acute, or chronic . pain
The target population for this device is patients with chronic, acute pain syndrome, and/or recovering from orthopedic related surgery.

Comparison to Predicate Devices:

The modified device has the same technological characteristics as the predicate devices. The form, fit, function and method of operation are similar.

Conclusion:

The T.E.A.R. Tech3 has the same intended use and technological characteristics as the predicate devices. No new questions of safety or effectiveness have been raised; therefore the T.E.A.R. Tech3 is substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 2003

Mr. Alan Wade Director, Product Development VisionQuest Industries, Inc. 18011 Mitchell South Irvine, California 92614

K030507 Re:

Trade/Device Name: T.E.A.R. Tech3, Model # 44TT03 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Codes: IPF and LIH Dated: February 13, 2003 Received: February 19, 2003

Dear Mr. Wade:

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

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Page 2 - Mr. Alan Wade

applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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,

Mark N. Milhurn

Celia M. Witten, M.D., Ph.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

The T.E.A.R. Tech3 IF/Muscle Stimulator is a combination device and has the same indications for use as two different types of predicate devices.

The High Volt Pulsed Current Stimulator and Neuromuscular Electrical Stimulators share the same indications for use as listed below:

Relaxation of muscle spasms ●
Prevention or retardation of disuse atrophy ●
Increases local blood circulation
Promotes muscle re-education and range of motion .
Maintaining and increasing range of motion .
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis ●

Interferential Stimulators have one additional indication for use:

Provides symptomatic relief and management of post surgical, acute, or chronic pain .
The target population for this device are patients with chronic, acute pain syndrome, and/or recovering from orthopedic related surgery.

Mark A. Milluzzo

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

510(k) Number _

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).