The TENS and Microcurrent modes of the Trio 300 are indicated for the symptomatic relief of chronic intractable pain. They are also indicated for the treatment of post-traumatic and post-surgical pain. The electrical muscle stimulation (EMS) mode is indicated for relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, maintain or increase range of motion, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Device Description

The Trio 300 Multi-Mode Electrical Stimulator is a small, portable, battery-powered electrical stimulator device that has four stimulation modes, (1) TENS, (2) EMS, (3) microcurrent, and (4) programmable. The device has an LED screen that serves as the interface with the user to specify options, provide messages, and display parameters. The device is supplied with an AC adaptor for line current operation.

The Trio 300 consists of the pulse generator, A/C power adapter, and the surface electrodes.

The Trio 300 is a dual-channel electrical stimulator with four output modes. The device is equipped with a liquid crystal display (LCD) for communication with the user. The SELECT key allows the user to scroll through the options (e.g., mode) available at a particular point and the SET key allows the selection of the displayed option. The UP-ARROW and DOWN-ARROW keys allow the user to increase or decrease certain selected parameters.

AI/ML Overview

The provided text is a 510(k) summary for the Trio 300 Multi-Mode Electrical Stimulator, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this type of regulatory submission. This document primarily addresses electrical safety and electromagnetic compatibility, and design qualification to meet internal specifications, not clinical performance against acceptance criteria for an AI/algorithm-based device.

Here's an breakdown of what can be extracted and what information is not available from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from text)	Reported Device Performance (from text)
Compliance with EN-60601 electrical safety standard	Ito has certified compliance with EN-60601. Testing to UL 2601 is in progress.
Compliance with EN 60601-1-2 standard for electromagnetic compatibility	TUV has issued an Attestation of Conformity for the Trio 300 in regard to the EN 60601-1-2 standard.
Meeting design specifications (for design qualification testing)	The design qualification testing demonstrated that the Trio 300 met its design specifications.

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

Not Applicable. The described testing is for electrical safety, electromagnetic compatibility, and design qualification, not for clinical performance using a "test set" in the context of an AI/algorithm study. There's no mention of patient data.

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

Not Applicable. No clinical ground truth was established from experts for the stated testing.

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

Not Applicable. No clinical ground truth adjudication method is described.

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 not an AI-assisted device, and no MRMC study was conducted.

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

Not Applicable. This is a direct electrical stimulator, not an algorithm.

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

Not Applicable. The "ground truth" for the reported tests refers to standards (electrical safety, EMC) and internal design specifications, not clinical outcomes or expert labels.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device, so there is no training set mentioned.

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

Not Applicable. There is no training set.

Summary based on the provided document:

The Trio 300 Multi-Mode Electrical Stimulator is a hardware device. The "acceptance criteria" and "study" described in the 510(k) summary pertain to basic device safety and functionality standards (electrical safety, electromagnetic compatibility, and meeting design specifications). These are not performance criteria related to clinical efficacy or diagnostic accuracy, which would be typical for an AI/algorithm-based medical device where the requested information would be relevant. The document's purpose is to demonstrate substantial equivalence to existing predicate devices based on technological characteristics and intended use, supported by adherence to safety and design standards.

Summary

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/K550787

510(k) Summary

Trio 300 Multi-Mode Electical Stimulator

Common/Classification Name: 21 CFR 882.5890, 21 CFR 890.5850

lto Co., Ltd. 3-3-3 Toyotama-Minami Nerima-ku, Tokyo 176-8605 JAPAN

Contact: H. Okada , Prepared: March 8, 1999

LEGALLY MARKETED PREDICATE DEVICES A.

The Trio 300 Multi-Mode Electrical Stimulator is a device that combines four types of electrical stimulation in one device. It has a TENS mode, an electrical muscle stimulation mode, a microcurrent mode, and a general programmable mode. Since it appears that this particular combination of modes has not been present to date in any single device, it is necessary to claim substantial equivalence to more one predicate device. The TENS, microcurrent, and than programmable modes of the Trio 300 Multi-Mode Electrical Stimulator are substantially equivalent to the corresponding modes of the Acutron Mentor Model 961 (K981976). The electrical muscle stimulation (EMS), TENS, and programmable modes of the Trio 300 Multi-Mode Electrical Stimulator are substantially equivalent to the Bio-Medical Research Model NT2000 Stimulator (K972244).

B. DEVICE DESCRIPTION

The Trio 300 consists of the pulse generator, A/C power adapter, and the surface electrodes.

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SET key allows the selection of the displayed option. The UP-ARROW and DOWN-ARROW keys allow the user to increase or decrease certain selected parameters.

C. INTENDED USE

The TENS mode of the Trio 300 is indicated for the symptomatic relief of chronic intractable pain. It is also indicated for the treatment of post-traumatic and post-surgical pain. The electrical muscle stimulation (EMS) mode is indicated for relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle reeducation, increase local blood circulation, maintain or increase range of motion, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

D. SUBSTANTIAL EQUIVALENCE SUMMARY

The Trio 300 Multi-Mode Electrical Stimulator is a medical device, and it has the same indications for use and target population as the legally marketed predicate devices. The Trio 300 Multi-Mode Electrical Stimulator has the same technological characteristics as the predicate devices. This premarket notification will describe the characteristics of the Trio 300 Multi-Mode Electrical Stimulator in sufficient detail to assure substantial equivalence except for a few of the characteristics where performance testing was carried out (e.g., electrical safety).

E. TECHNOLOGICAL CHARACTERISTICS

The Trio 300 and one of the predicate devices all portable, batterypowered, electronic pulse generator devices with surface electrodes. The Trio 300 and both predicate devices are microprocessor-based and employ digital and analog circuits to produce the specified waveforms and levels. All employ an LCD screen as the user interface.

The electrodes that will be supplied with the Trio 300 Multi-Mode Electrical Stimulator are manufactured in the U.S. by Axelgaard Manufacturing Company and are currently marketed products (K970426). Two sizes are available, 2″ by 2″ and 2″ by 3.5″.

F. TESTING

Testing was carried out to assure compliance with recognized electrical safety standards. Ito has certified compliance with the EN-60601 standard for electrical safety. Testing to UL 2601 is in progress.

TUV has issued an Attestation of Conformity for the Trio 300 in regard

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to the EN 60601-1-2 standard for electromagnetic compatibility.

The design qualification testing demonstrated that the Trio 300 met its design specifications.

G. CONCLUSION

This pre-market submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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Image /page/3/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of an eagle or bird-like figure with three distinct, curved lines representing its body and wings. The overall design is simple and conveys a sense of official government authority.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 20 1999

T. Whit Athey, Ph.D. Senior Consultant Representing ITO Co., Ltd. C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852

K990787 Re: Trade Name: Trio 300 Multi-Mode Electrical Stimulator Regulatory Class: II Product Codes: IPF, GZJ Dated: July 21, 1999 Received: July 21, 1999

Dear Dr. Athey:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that,

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Page 2 - T. Whit Athey, Ph.D.

through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Calvin M. Hite, Ph.D.

Witten, M. Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Dcoello

ivision oNGeneral Restorative Devic 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).