The MyoTrac Infiniti system is indicated for the ongoing treatment of the following conditions: Relaxation of Muscle Spasms, Prevention of disuse atrophy, increasing local blood circulation, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or increasing range of motion and Stroke Rehab by Muscle re-education. It is also used for Relaxation & Muscle Re-Education purposes.

Device Description

The MyoTrac Infiniti device is an electrical muscle stimulator for contraction of muscles as indicated below. The MyoTrac Infiniti is also an electromyography device. It is intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves and to monitor and display the electrical activity produced by nerves. The indications for use are muscle re-education, relaxation and biofeedback.

AI/ML Overview

Here's an analysis of the provided text regarding the MyoTrac Infiniti System, focusing on acceptance criteria and supporting studies:

This 510(k) premarket notification (K053266) for the MyoTrac Infiniti System does not contain specific acceptance criteria or a dedicated study designed to prove the device meets such criteria in the conventional sense of a clinical trial demonstrating performance metrics against quantitative thresholds.

Instead, the submission focuses on substantial equivalence to predicate devices. The "performance data" section primarily refers to non-clinical tests verifying product specifications, system validation, safety, and EMC testing, along with biocompatibility assessments of electrodes. The core argument for equivalence is a direct comparison of functional and hardware specifications with legally marketed predicate devices.

Therefore, many of the requested categories within your prompt cannot be directly answered from the provided text. I will address what is available and indicate when information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit "acceptance criteria" (e.g., "sensitivity > X%", "accuracy > Y%") are not presented in this 510(k) summary. The "performance" is demonstrated through substantial equivalence to predicate devices based on technical specifications and safety testing.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (MyoTrac Infiniti)
Safety and Effectiveness: No new questions of safety or effectiveness raised compared to predicates.	Identified as safe and effective for its intended use.
Technical Specifications: Functional and hardware specifications fall within the range of, or are comparable to, predicate devices.	Meets or exceeds most technical specifications of predicate devices (e.g., stimulator output, waveform, max phase charge, frequency, pulse width). Differences (e.g., higher max phase charge, RMS EMG vs. peak EMG) are deemed not to affect safety or effectiveness.
Biocompatibility: Materials in contact with patients are safe.	Axelgaard and Thought Technology electrodes were laboratory tested and found safe under required standards.
EMC Testing: Compliance with electromagnetic compatibility standards.	Performed (stated in "Performance Data").
System Validation: Verification of product specifications and system function.	Performed (stated in "Performance Data").

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

Sample Size for Test Set: Not applicable. This document describes a 510(k) submission for substantial equivalence based on technical comparisons and non-clinical testing, not a clinical study with a "test set" of patient data.
Data Provenance: Not applicable for a patient data test set. The data provenance for component testing (e.g., biocompatibility) would be laboratory testing reports.

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

Not applicable. There is no clinical "test set" with ground truth established by experts discussed in this submission.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical "test set" requiring an adjudication method.

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 device is a biofeedback and muscle stimulation system, not an AI-assisted diagnostic tool that would typically undergo an MRMC study with human readers interpreting results.

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

This device is not an algorithm-only medical device. It is a physical medical device (stimulator and biofeedback unit) used with human-in-the-loop operation.
The "standalone performance" is addressed by the comparison of its technical specifications to predicate devices and verification of its own product specifications.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the purpose of this 510(k) submission, the "ground truth" for proving substantial equivalence is the technical specifications and established safety/effectiveness profiles of the predicate devices, along with the results of internal non-clinical tests (verification, validation, safety, EMC). There is no patient-reported outcomes, pathology, or expert consensus used to establish ground truth for a novel performance claim in this documentation.

8. The Sample Size for the Training Set

Not applicable. This device does not employ an AI algorithm requiring a "training set" of data.

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

Not applicable, as there is no training set for an AI algorithm.

Summary

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DEC 2 9 2005

K053266

Premarket Notification 510(k) Summary

Date Prepared:	20-10-2005
Applicant:	Thought Technology Ltd2180 Belgrave AvenueMontreal QuebecCanada H4A 2L8
Contact:	Suresh SugirtharajaDesign Coordinator
Tel:	489-8251 x127
Fax:	489-8255

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Device Name
Trade Name:	MyoTrac Infiniti System
Common Name:	Powered muscle stimulator and biofeedback device
Classification Name:	89IPF, 84HCC	(882.5050 and 890.5850)ClassII
Predicate Devices
Trade Name:	Danmeter AutoMove AM800 EMG Triggered Stimulator(K972997)
Classification Name:	89IPF, 84HCC, ClassII
Trade Name:	Mettler Electronics Corp Sys STIM 208 powered musclestimulator (K031017)
Classification Name:	89IPF, ClassII

Description of Device:

The MyoTrac Infiniti device is an electrical muscle stimulator for contraction of muscles as indicated below.

The MyoTrac Infiniti is also an electromyography device. It is intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves and to monitor and display the electrical activity produced by nerves. The indications for use are muscle re-education, relaxation and biofeedback.

Intended Use

Indications for use:

Biofeedback, Relaxation and Muscle Reeducation. ●
Relaxation of Muscle Spasms. .
Prevention or retardation of disuse atrophy. .
Increasing local blood circulation. .
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. .
. Maintaining or increasing range of motion.
Stroke Rehab by Muscle re-education. .

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Technical Characteristics Comparison to Predicate Device

MyoTrac Infiniti is compared to AutoMove AM800 (K972997) and Sys STM 208 (K031017). The technical specifications of the MyoTrac Infiniti substantially fall within the range of the AutoMove AM800. The differences are that the MyoTrac Infiniti is able to deliver more charge per pulse and more power density than the AutoMove AM800 but still with in the range of Sys STIM 280 and power density limits specified by 21 CFR 890 5850 (Powered Muscle Stimulator) and outputs EMG RMS vs. EMG peak from the AutoMove AM800. These differences should not affect the safety or effectiveness of the device.

	PROPOSED DEVICEMyoTrac Infiniti	Danmeter AutoMove AM800EMG Triggered StimulationK972997	SYS STIM 208K031017
Intended Use	Muscle Stimulation andEMG Biofeedback	Muscle Stimulation andEMG Biofeedback	Powered MuscleStimulation
Primary Functions	Delivery of stimulation andreading of Electromyography	Delivery of stimulation andreading of Electromyography	Delivery of stimulation
Stimulator Output	0 - 100mA at 500ohms	0 -60mA at 2.5Kohms	0-184mA at 500 ohms
Waveform	Asymmetrical Balanced PulsedCurrent	Biphasic, alternating andmonophasic Current	Asymmetrical BiphasicRectangle with zero netDC
Maximum PhaseCharge	60μC	31μC	56μC
Frequency	2 – 100 Hz	10 - 100 Hz	1-80Hz
Peak pulse intensity	100mA	60mA	184mA
Pulse Width	50 - 400μs	100 – 400 μs	200-800μS
Ramps	0 - 10sec on and off ramp	0.5 sec to 10 sec
Duty Cycle	On(sec): 2 -20Off(sec): 2-50	On(sec): 2-20Off(sec): 2-50	ON 0.375 to 3.75secOFF 0.375 to 3.75sec
Session Duration(min)	1 to 120 minutes	10 to 800 minutes or continue
Programmablefeatures	Frequency, Current intensity,pulse width, ramp up and down,session length, thresholdtrigger by the patient and thephysician.	Frequency, Current, Pulsewidth, ramp up and down,session duration, threshold fortrigger and duty cycle. Bypatient or physician.
Surface Electrodes	K874469A AxelGaardelectrodes for EMG or Stim.K935213 Electrodes Uni-Gelfor EMG onlyK903497A Triode Electrodesfor EMG onlyK903497A Single Electrodesfor EMG only	PALS FLEX electrodes -AxelGaard - K8764469A
Current Density (fulloutput)	Axelgaard Model 8952200.24mA/cm²Axelgaard Model 8953400.08mA/cm²	0.5 mA/ cm²	0.132mA/ cm²
Power Density (fulloutput @ 500ohms)	Axelgaard Model 89522016mW/cm²	13mW/cm²	12mW/ cm²

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	Axelgaard Model 8953405.3mW/cm²
EMG Ranges in μV	0-5, 0-10, 5-10, 0-20, 5-20, 10-20, 0-50, 10-50, 0-100, 50-100,0-200, 50-200, 100-200, 0-500,100-500, 0-1000, 0-2000	2 - 2000μV	N/A
EMG Bandwidth	20 – 500 Hz	50 – 1000 Hz	N/A
EMG SignalProcessing	Root Mean Square (RMS)	Peak	N/A
EMG Detection	Bipolar	Bipolar	N/A
Work Period (sec)	2 – 20 seconds	2 - 20 seconds	0.375 to 3.75sec
Rest Period (sec)	2 - 50 seconds	2 - 50 seconds	0.375 to 3.75sec
Session Duration(min)	1-120 minutes	1 – 30 minutes	0-60minutes
Feedback Modes	Line Graph, Bar Graphs, DigitalDisplay	Bar Graphs, Digital Displays	Digital

。

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Performance Data

Non-clinical tests were performed consisted of verification of the product specification, system validation, safety and EMC testing. Device equivalency is determined by a direct comparison of the device functional and hardware specifications of MyoTrac Infiniti system with the legally marketed predicate devices, Automove AM800 EMG triggered stimulator and Sys STIM 208 powered muscle stimulator. Such a comparison table is present in the above section

Biocompatibility:

The Axelgaard EMG/Stimulation electrodes (K874469A), Thought Technology single, triode and Uni-gel Electrodes for EMG (K903497A & K935213) have been laboratory tested for the safety of the materials and were found to be safe under the standard required for each test.

Conclusion:

The MyoTrac Infiniti system is safe and effective for its intended use. The MyoTrac Infiniti system is substantially equivalent to the predicate devices.

End of 510(k) Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus.

Public Health Service

DEC 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Thought Technology Limited c/o Mr. Robert Mosenkis CITECH 5200 Butler Pike Plymouth Meeting, PA 19462

Re: K053266/S1

Trade/Device Name: MyoTrac Infiniti System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF, HCC Dated: December 14, 2005 Received: December 16, 2005

Dear Mr. Mosenkis:

We have reviewed your Section 510(k) premarket notification of intent to narket the device indication indical we nave revewed your Section 910(t) promantee is substantially equivalent (for the indications for referenced above and nave decemined are as a see as a see a marketed in interstate winners the use stated in the enclosure) to regally manufacture Medical Device Amendments, or to devices that prior to May 26, 1970, the chacinon auto of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal Food, Drug, May may have been reclassified in accordance with the premarket approval application (PMA). You may, Act (Act) that do not require apploval of a provisions of the Act. The general therefore, market the device, subject to the genirements for annual registration, listing of devices, good controls provisions of the necesses institutions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in h If your device is classified (see ao re) into Existing major regulations affecting your device can be may be subject to such additional volts of Environs. Title 21, Parts 800 to 898. In addition, FDA may publish found in the Sous ents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination as fithe Assurance Flease be advised that 1 177 - 15 usualled of aevice complies with other requirements of the Act or any FDA has made a decommation administered by other Federal agencies. You must comply with all
Federal statutes and regulations administered by other Federal (1) CED Box 807) Federal statutes and regulations administered by on the segistration and listing (21 CFR Part 807); the rive s requirements) in the manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Mr. Robert Mosenkis

This letter will allow you to begin marketing your device as described in your section 510(k) I his letter will anow you to begin marketing your arrial equivalence of your deversits vour develop premarket notification: The PDA midnig of substanted vice 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 If you desire specific advice for your do not on one one as not the regulation entitled, contact the Office of Comphalled at (210) 210 - 120 - 120 .97). You may obtain other "Misbranding by relerence to preharter nothedron" (2) Cfrom the Division of Small Manufacturers, general information on your responsionnies and its tool-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Вавда Виелино

Mark N. Melkerson Acting 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): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The MyoTrac Infiniti system is indicated for the ongoing treatment of the The Myo Frac Immit System is Indiation of Muscle, Spasms, Prevention of Musical rollowing conditions: Notaxation of more of culation, immediate post-surgical disuse atropity, increasing lood blood on us thrombosis, Maintaining or increasing stimulation of call muselou to problem to re-education. It is also used for range of motion anxation & Muscle Re-Ec ucation purposes.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/ OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark H. Mulkerson

: Vision Sign-Off) Orvision of General, Restorative and Neurological Devices

Number K053266

Page 12 of 27

.... !

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).