The MyoTrac Infiniti system is indicated for acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscle through reflexive mechanisms, strengthening of pelvic floor muscle. It is also indicated during incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal or gluteal muscles.

The MyoTrac Infiniti system is also indicated for the ongoing treatment of the following conditions: 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 and Stroke Rehab by Muscle re-education. It is also used for Biofeedback, Relaxation & Muscle Re-Education purposes.

Device Description

The MyoTrac Infiniti device is a non-implanted electrical stimulator for urinary incontinence, it is intended to re-train the urinary continence mechanisms by way of electrical stimulation applied to the pelvic floor musculature and surrounding structures. The device is indicated for treatment of patients with stress incontinence, urge incontinence or mixed incontinence (a combination of stress and urge incontinence). The indications for this use and labeling will be a subset of the overall indications for use. The MyoTrac Infiniti is an electrical muscle stimulator for contraction of muscles as well.

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 EMG biofeedback.

AI/ML Overview

The provided text describes the MyoTrac Infiniti system and its substantial equivalence to predicate devices, focusing on technical characteristics and intended use. However, it does not include a study that proves the device meets specific acceptance criteria in the way you've outlined for performance metrics (e.g., sensitivity, specificity, accuracy).

Instead, the document details a 510(k) premarket notification, which is a regulatory submission to demonstrate that a new medical device is "substantially equivalent" to a legally marketed predicate device. This process typically relies on comparing technical specifications and intended use rather than conducting new clinical performance studies with acceptance criteria, sample sizes, and ground truth as would be done for a novel or high-risk device.

Therefore, many of your requested points cannot be directly answered from the provided text.

Here's a breakdown of what can be extracted and what information is missing:

The device described is the MyoTrac Infiniti System, a non-implanted electrical continence device, powered muscle stimulator, and biofeedback device.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document in the format of a clinical performance study with specific acceptance criteria (e.g., sensitivity, specificity thresholds) and corresponding reported performance values. The document focuses on demonstrating substantial equivalence through a comparison of technical characteristics and intended use with predicate devices.

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

Sample Size for Test Set: Not applicable/Not provided. The document does not describe a clinical test set or study with human subjects for performance evaluation in the way you've asked. The "performance data" section (page 6) refers to "non-clinical tests" like verification of product specifications, system validation, safety, and EMC testing. Device equivalency is determined by comparing its functional and hardware specifications to predicate devices.
Data Provenance: Not applicable.

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

Not applicable/Not provided. No clinical test set with ground truth established by experts is described.

4. Adjudication method for the test set

Not applicable/Not provided. No clinical test set requiring adjudication 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

Not applicable/Not provided. This device is an electrical stimulator/biofeedback device, not an AI-powered diagnostic or assistive tool for human readers, so an MRMC study is not relevant to its function.

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

Not applicable/Not provided. This is a physical medical device for treatment and biofeedback, not an algorithm. Its performance is inherent in its hardware, software, and physical interaction, not a standalone algorithmic output.

7. The type of ground truth used

Not applicable/Not provided. For the purposes of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is the established safety and efficacy of the predicate devices and the MyoTrac Infiniti's ability to match their intended use and technical specifications. There is no mention of pathology, expert consensus, or outcomes data used to establish ground truth for a performance study of the MyoTrac Infiniti itself.

8. The sample size for the training set

Not applicable/Not provided. This is not a machine learning or AI-driven device that requires a training set in that context.

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

Not applicable/Not provided.

Summary of Device Acceptance/Equivalency based on the document:

The MyoTrac Infiniti system's "acceptance criteria" and "proof" are based on its substantial equivalence to existing legally marketed predicate devices, as demonstrated through a comparison of their technical characteristics and intended uses.

Acceptance Criteria (Implicit for 510(k)): The MyoTrac Infiniti System must have the same intended use and similar technological characteristics as predicate devices such that any differences do not raise new questions of safety or effectiveness.
Study Proving Acceptance: The main "study" (or rather, the demonstration for regulatory clearance) is the comparison table of technical characteristics and the statement of intended use.
- "Performance Data": The document explicitly states (page 6): "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..."
- Biocompatibility: The related sensors underwent laboratory testing for material safety.
- Conclusion: "The MyoTrac Infiniti system is safe and effective for its intended use. The MyoTrac Infiniti system is substantially equivalent to the predicate devices." (page 6)

The document lists multiple predicate devices (Pathway CTS 2000, InCare PRS Pelvic Floor Therapy System, Evadri Bladder Control System, K.E.A.T., and Detrusan 500 Incontinence Therapy System) and provides a detailed table comparing various features like frequency, pulse intensity, pulse width, ramp settings, duty cycle, session duration, programmable features, probe types, power density, EMG ranges, bandwidth, signal processing, detection, and feedback modes. The "acceptance" is based on these comparisons demonstrating similarity to devices already cleared by the FDA.

Summary

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K os3434
page 1 of 8

MAR 1.5 2006

Premarket Notification 510(k) Summary

Date Prepared:	03-07-2006
Applicant:	Thought Technology Ltd2180 Belgrave AvenueMontreal QuebecCanada H4A 2L8
Contact:	Suresh SugirtharajaDesign Coordinator
Tel:	489-8251 x127
Fax:	489-8255

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K053434
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Intended Use

Indications for use:

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chnical Characteristics Comparison to Predicate Do

This device is compared to Patimosystem (K02906), hCare PRS Pelvi Floor Theray System
(K03410), The technical (K0304), K. S. T. (K0254), K. S. Parisen (K. Park Server (TS Par

PROPOSEDDEVICETrac Infiniti	Pathway CTS2000K023906	InCare PRSK974048	K.E.A.TK002154	Evadri BladderControl SystemK050483 (Predicatewith AC powersource)	Detrusan 500(K994109)	Frequency	Peak pulse intensity	Pulse Width	Ramps	Duty Cycle	Session Duration (min)	Programmable features	Vaginal EMG/Stim Probe	Vaginal EMG Probe	Id ProbeMuscleandred byal.	Pathway AnalEMG/StimulationSensor K993976	InCare AnalSTIM/EMG ProbeK930530	Unknown	Urostym AnalSTIM/EMG ProbeK993721	PowerDensity (fulloutput @500ohms)		EMG Rangesin μV	EMGBandwidth	EMG SignalProcessing	EMGDetection	Work Period(sec)	Rest Period(sec)	SessionDuration (min)	FeedbackModes
Treatment ofurinaryincontinence	Treatment ofurinaryincontinence	Treatment of urinaryincontinence	Treatment of (stress,urge & mixed) urinaryincontinence	Treatment of urinaryincontinence	Treatment of urinaryincontinence	12.5, 50, 100, 200 Hz	100mA	0.2, ms	0 - Duty Cycle on and off ramp.	On (sec): 2 - 20Off (sec): 2 - 50	1-120 minutes	Frequency, Current intensity, pulse width, ramp up and down, session length, by the patient and the physician.Physicians can lock the features for the patient with the exception of the current intensity.	Saint-Cloud Probe for vaginal Muscle Stimulation and Biofeedback, manufactured by Saint-Cloud International.Femelex Probe for vaginal Muscle stimulation and Biofeedback manufactured by PhysioMed.	Thought Technology Ltd Vaginal Probe for	y Ltdbe for	Unknown	Unknown	N/A	Unknown	St - Cloud Vaginal22.84mW/cm²	Femelex11.32mW/cm²St - Cloud Rectal194mW/cm²	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	20 - 500 Hz	Root Mean Square(RMS)	Bipolar	2 - 20 seconds	2 - 50 seconds	1-120 minutes	Line Graph, BarGraphs, DigitalDisplay, Signallinked animations
EMG Biofeedback	EMG Biofeedback	EMG Biofeedback	Delivery of stimulation	EMG Biofeedback	Delivery of stimulation	12.5, 50, 100, 200 Hz	100mA	0.3ms fixed	2 sec on ramp, 1 sec off ramp	On(sec): 1-80Off(sec): 0-80	0-30	None by Patient: Frequency, Duty cycle, Session Length by physician.	Pathway Vaginal EMG/Stimulation Sensor K993976	Unknown	2	2.31 cm²	7.98 cm²	7.854 cm²	Unknown	Pathway VaginalEMG/Stim Sensor:7.79 mW/cm²	Pathway AnalEMG/Stim Sensor:8.49 mW/cm²	0 - 5, 0 - 30, 0-100, 0 - 1000μVranges	20 - 500 Hz	Root Mean Square(RMS)	Bipolar	1 - 80 seconds	0 - 80 seconds	1 - 60 minutes	Line Graph, BarGraphs, DigitalDisplays, Signallinked Animations
Delivery ofstimulationand reading ofElectromyography	Delivery ofstimulation andreading ofElectromyography	Delivery of stimulationand reading ofElectromyography	6V Rechargeablelithium-ion battery	Isolated AC to DCpower adapter,115/230VACswitchable input to6VDC output	Main Powered	12.5, 50, 100, 200 Hz	30V	0.3, 1 ms	On Ramp: 20%, 40%, 60%, 80%, 100% of ON Time, No OFF Ramp	On(sec): 1-80Off(sec): 0-80	0-30	None by Patient: Frequency, Duty cycle, Session Length by physician.	InCare Vaginal STIM/EMG probe K891773	Unknown	y	2.12 cm²	1.99 cm²	Unknown	Unknown	InCare VaginalSTIM/EMG47mW/cm²	In Care AnalSTIM/EMG239mW/cm²	0-5, 0-10, 0-25, 0-100, 0-250, 0-500 μVranges	100 - 500 Hz	Root Mean Square(RMS)	Bipolar	1 - 80 seconds	0 - 80 seconds	1 - 60 minutes	Unknown
1.5Vone orRechargeable NiMHbattery pack	Unknown	Unknown	0-100mA	0-30Vdc 1% or 5%increment	0-30V	12.5, 50 Hz	100mA	0.3ms fixed	Unknown	ON: 5 sec OFF 5secON: 5sec OFF: 10sec	0-30	unknown	Hollister Vaginal STIM Probe K891773	N/A	2.45	Pathway VaginalEMG/Stim Sensor:43m A/cm²	InCare VaginalSTIM/EMG3mA/ cm²	12.73mA/cm²	Unknown	81.02 mW/cm²	Unknown	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
-15WMedical Class IIpower adapter500mA	AsymmetricalBalanced PulsedCurrent28μC	0-30VDC	BalancedSymmetrical Biphasic	Balanced Biphasic,no DC component	Square SymmetricalBalanced Biphasic	10, 12.5, 20, 50, 100, 200 Hz	0-30Vdc 1% or 5% increment	0.3, 1 ms	Unknown	ON: 1-80 secOFF: 0-80 sec	1-30min	Unknown	Unknown	N/A	Vaginalcm²	Pathway AnalEMG/Stim Sensor:47m A/cm²	In Care AnalSTIM/EMG18mA/ cm²	Unknown	16.4mA/cm²	Unknown	120 mW/cm²	0-5, 0-10, 0-25, 0-50,0-100, 0-250, 0-200	20-500 Hz	Root Mean Square(RMS)	Bipolar	1 - 80 sec	0 - 80 sec	1 - 60 min	Unknown
SymmetricalBalanced Pulsed		60μC	Unknown	Unknown	64μC	1-100Hz	30V	0.01-0.4ms1/12th of the intensity (V)		On(sec): 1 - 60Off(sec): 0-60	0-30min	None by Patient: Pulse Width, Frequency, Duty cycle, Session Length by physician.	Urostym Vaginal STIM/EMG Probe K990041	Unknown	Unknown	120 mW/cm²	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A

K053434
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K053434
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K053454
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K053434
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K053434
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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; Pathways CTS 2000 pelvic floor training system (K023906), InCare PRS Pelvic Floor Therapy System (K974048), Evadri Bladder Control System (K050483), K.E.A.T (K002154) and Detrusan 500 Incontinence Therapy System (K994109). Such a comparison table is present in the above section.

Biocompatibility:

The Thought Technology Vaginal EMG Sensor (K932149B), Thought Technology Rectal EMG Sensor (K932149B), St-Cloud Vaginal EMG/Stimulator Electrode, St-Cloud Rectal EMG/Stimulator Electrode, Physiomed Femilex Vaginal EMG/Stimulator Electrode, 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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K053434
Page 8 of 8

Device Name

Trade Name: Common Name: Classification Name: MvoTrac Infiniti System Non Implanted Electrical Continence Device 78 KPI. 84HCC ClassII (876.5320, 882.5050 and 890.5850)

Predicate Devices

Classification Name:

Trade Name:

Pathway CTS 2000 Pelvic Floor Training System (K023906) Classli, 78 KPI, 84HCC

InCare PRS Pelvic Floor Therapy System (K974048) ClassII, 78 KPI, 84HCC

Trade Name: Classification Name: K.E.A.T (K002154) ClassII, 78 KPI

Trade Name: Classification Name: Evadri Bladder Control System (K050483) ClassII, 78 KPI, 84HCC

Trade Name: Classification Name: Detrusan 500 Incontinence Therapy System (K994109) ClassII, 78 KPI

Description of Device:

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Image /page/8/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the edge. Inside the circle is a stylized image of an eagle with its wings spread, with three wavy lines below it. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR ! 5 2006

Thought Technology, Ltd. c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298

Re: K053434

Trade/Device Name: MyoTrac InfinitiTM System Regulation Number: 21 CFR §876.5320 Regulation Name: Non-implanted electrical implanted continence device Product Code: KPI Regulation Number: 21 CFR §890.5850 Regulation Name: Powered muscle stimulator Product Code: IPF Regulation Number: 21 CFR §882.5050 Regulation Name: Biofeedback device Product Code: HCC Regulatory Class: II Dated: February 27, 2006 Received: February 28, 2006

Dear Mr. Mosenkis:

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 (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 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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This letter will allow you to begin marketing your device as described in your Section 510(k) This leter with anow you to ogen mating of substantial equivalence of your device to a legally premarket notification: "The 1197 mining sification 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 If you desire specific ad not of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation on your responsibilities under the Act from the 807.77). I ou may obtain one general national 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/industry/support/index.html

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K053434

Device Name: MyoTrac Infiniti System

Indications for Use:

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)

David le. Syverson
(Division Sign-Off)

(Division Sign-Off) ion of Reproductive, Abdomina and Radiological Device 510(k) Number

Page of

Regulation Number and Section

§ 876.5320 Nonimplanted electrical continence device.

(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).