The RT300 pediatric version is intended for population ages 4 to 12 years.
The RT300 is intended for use with a surface electrical stimulation garment for population ages 12 and above.
The RT300 is for prescription use only.

Device Description

The RT300 is a Functional Electrical Stimulation (FES) cycle ergometer which is composed of:

A motorized leg cycle ergometer (RTI part number SA100047 for adults and SA100044 for children)
An optional motorized arm crank (RTI part number PP102663)
An FES controller with up to two 6 channel stimulators (RTI part number SA216172)
Up to 5 additional wireless single channel stimulators (RTI part number SA216128)
A leg and optional arm stimulation cable which connects the stimulator to cutaneous electrodes
Cutaneous electrodes (up to 24 electrodes for up to 12 stimulation channels)
An interface to a remote database for the storage and retrieval of therapy settings and the storage of therapy session logs
An interface to a pulse oximeter for the display and recording of pulse and SpO2 levels and provision of alarming based on the data
A garment incorporating electrodes for lower extremity cycling in population ages 12 and above (RTI part number FA105486)

This system allows a person with impaired upper or lower extremity movement to undertake cycle erqometry both actively (utilizing FES evoked upper or lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor). The system combines a Windows based tablet, cycle ergometer, and stimulators in a single unit. The system is controlled by the Sage software that runs on the tablet. The Sage software delivers stimulation to the designated muscle groups in a coordinated fashion based on angle information from the ergometer. In doing so the system facilitates a smooth cycling motion throughout the therapy session.

AI/ML Overview

Here are the acceptance criteria and study details for the RT300 FES Cycle Ergometer based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are defined by its safety and effectiveness endpoints across different intervention groups. The device's performance is reported across these same metrics.

Category	Intervention Group	Acceptance Criteria	Reported Device Performance
Safety	All Interventions	No treatment-related adverse reactions, muscle strain, joint strain, or fracture. Minimization of normal or blancheable erythema.	Cycling (15 patients, 434 sessions): 3 patients had normal erythema, 0 adverse reactions/injuries. Lower Extremity (33 patients, 920 sessions): 8 patients had normal erythema, 1 patient had blancheable erythema, 0 adverse reactions/injuries. Trunk (13 patients, 172 sessions): 3 patients had normal erythema, 1 patient had blancheable erythema, 0 adverse reactions/injuries. Upper Extremity (14 patients, 65 sessions): 8 patients had normal erythema, 0 adverse reactions/injuries. Pediatric (8 patients, 324 sessions): 6 patients had normal erythema, 0 adverse reactions/injuries.
Effectiveness	Cycling with Lower Extremity	Meet primary safety endpoint (no adverse reactions or other injuries).	Met primary endpoint with no adverse reactions or other injuries.
Effectiveness	Lower Extremity NMES	Clinically significant improvements in functional outcome measures (NRS, Berg Balance Scale, Biodex Dynamometer Torque, Overground Standing Test).	23 patients increased NRS by 16%; lower extremity NRS by 11%. 15 patients increased Berg scores by 47%. MVC torque increased for 8 lower extremity muscle groups in average of 9 patients by 152% - 3796%. 8 patients increased Overground Standing Test times by 7108%. Met primary endpoint.
Effectiveness	Trunk NMES	Clinically significant improvements in functional outcome measures (NRS, Berg Balance Scale, Modified Functional Reach, Independent Sitting, Trunk Scale).	11 patients increased NRS by 18%. 5 patients increased Berg scores by 50%. Modified reach scale increased 9 patients by 196%. Independent Sitting times increased in 3 patients 26583%. Trunk scale increased in 2 patients by 180%. Met primary endpoint.
Effectiveness	Upper Extremity NMES	Clinically significant improvements in functional outcome measures (NRS, Modified Functional Reach, Bilateral Upper Extremity Basic Strength, Modified Ashworth Upper Extremity scale).	11 patients increased NRS by 8%. Modified reach scale increased in 4 patients by 122%. Bilateral Upper Extremity Basic Strength increased in 3 patients by 8%. Modified Ashworth Upper Extremity scale increased in 3 patients by 3%. Met primary endpoint.
Effectiveness	Pediatric NMES	Clinically significant improvements in functional outcome measures (Pediatric NRS, Segmental Assessment of Trunk Control (SATCo)).	4 patients increased NRS by 88%. 3 patients increased SATCo by 35%. Met primary endpoint.
General Equivalence	All (device overall)	Safety and effectiveness profile similar to the predicate device, with new technological characteristics not raising new questions of safety and effectiveness.	Clinical testing demonstrated that the RT300 is as safe and effective as the predicate devices. The wider stimulation pulses utilize the same stimulators and control system and do not raise new questions of safety and effectiveness.

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

Test Set Sample Sizes:
- Cycling with Lower Extremity NMES: 15 patients
- Lower Extremity NMES: 33 patients
- Trunk NMES: 13 patients
- Upper Extremity NMES: 14 patients
- Pediatric NMES: 8 patients (ages 2-13 years old)
Data Provenance: The document does not specify the country of origin. The study was a "multi-arm study with patients serving as their own control," indicating a prospective study design.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of diagnostic accuracy studies. Instead, the study uses functional outcome measures (e.g., Neuromuscular Recovery Scale, Berg Balance Scale) and clinical observation for adverse events, which are assessed by the study's clinical team. No specific number or qualifications of experts for ground truth establishment are provided.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (like 2+1 or 3+1) for the test set. The effectiveness endpoints involved changes in various clinical scales and measurements, likely recorded by the clinical team, and safety endpoints were observed and documented.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study evaluates the effectiveness of a medical device (FES cycle ergometer) for rehabilitation, not a diagnostic imaging AI system or a system that assists human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

The RT300 FES Cycle Ergometer is a therapeutic device that requires human interaction (patient use, clinician setup and monitoring) and is not an algorithm-only diagnostic tool. Therefore, a standalone (algorithm only) performance assessment, as might be done for an AI diagnostic device, was not performed. The device itself is the "standalone" subject of performance testing, but always with a human-in-the-loop for its intended use.

7. The Type of Ground Truth Used

The "ground truth" for this study is based on:

Clinically significant improvements in functional outcome measures: These include scores from standardized scales (e.g., Adult/Pediatric Neuromuscular Recovery Scale, Berg Balance Scale, Modified Functional Reach, Modified Ashworth Upper Extremity scale, Segmental Assessment of Trunk Control), objective measurements (Biodex Dynamometer Torque, Overground Standing Test, Independent Sitting times), which represent a patient's actual functional ability and recovery.
Absence of treatment-related adverse events: Clinical observation and documentation of safety metrics such as adverse reactions, normal erythema, blancheable erythema, muscle strain, joint strain, or fracture.

8. The Sample Size for the Training Set

The document describes a clinical study to evaluate the device's safety and effectiveness. It does not refer to a "training set" in the context of machine learning or AI model development. The numbers of patients listed under each intervention (15, 33, 13, 14, 8) represent the participants in the clinical evaluation.

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

As this study is a clinical evaluation of a medical device and not the development of an AI model, the concept of a "training set" and its associated ground truth establishment does not apply. The functional outcome measures and safety observations described above serve as the evaluation criteria for the device's performance in the clinical study.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three heads, suggesting a focus on people and services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 11, 2017

Restorative Therapies, Inc. Andrew Barriskill CEO 1434 Fleet St. Baltimore, Maryland 21231

Re: K162470

Trade/Device Name: RT300 FES Cycle Ergometer Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI Dated: June 7, 2017 Received: June 8, 2017

Dear Mr. Barriskill:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael J. Hoffmann -S

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162470

Device Name RT300 FES Cycle Ergometer

Indications for Use (Describe)

The RT300 is intended for general rehabilitation for:

1. Relaxation of muscle spasms

Prevention or retardation of disuse atrophy
Increasing local blood circulation
Maintaining or increasing range of motion
Muscle re-education

The RT300 pediatric version is intended for population ages 4 to 12 years.

The RT300 is intended for use with a surface electrical stimulation garment for population ages 12 and above. The RT300 is for prescription use only.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

RT300 510(k) Summary

(1) Submitter's name, address, telephone number, a contact person, and the date the summary was prepared:

Restorative Therapies Inc 1434 Fleet St Baltimore, MD 21231

Contact Person: Andrew Barriskill Phone: 800 609-9166

Prepared on July 16, 2016.

(2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name:

Proprietary name: RT300 FES Cycle Ergometer Common name: External Functional Neuromuscular Stimulator Classification name:External Functional Neuromuscular Stimulator (21 CFR 882.5810) Regulatory Class: II Product Code: GZI

(3) Identification of the legally marketed device to which the submitter claims equivalence:

RESTORATIVE THERAPIES, INC. product: "RT300", K090750 RESTORATIVE THERAPIES, INC. product: "Xcite Clinical Station", K160614

(4) A description of the device that is the subject of the premarket notification submission.

The RT300 is a Functional Electrical Stimulation (FES) cycle ergometer which is composed of:

A motorized leg cycle ergometer (RTI part number SA100047 for adults and SA100044 for children)
An optional motorized arm crank (RTI part number PP102663)
An FES controller with up to two 6 channel stimulators (RTI part number SA216172)

Image /page/3/Picture/15 description: The image shows the logo for RTI International. The logo consists of the letters "RTI" in a sans-serif font, stacked vertically. To the left of the letters is a stylized graphic of curved lines that converge to a point. The logo is in a light blue color.

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Up to 5 additional wireless single channel stimulators (RTI part number SA216128)
A leg and optional arm stimulation cable which connects the stimulator to cutaneous electrodes
Cutaneous electrodes (up to 24 electrodes for up to 12 stimulation channels)
An interface to a remote database for the storage and retrieval of therapy settings and the storage of therapy session logs
An interface to a pulse oximeter for the display and recording of pulse and SpO2 levels and provision of alarming based on the data
A garment incorporating electrodes for lower extremity cycling in population ages 12 and above (RTI part number FA105486)

(5) Indications for Use:

The RT300 is intended for general rehabilitation for:

1. Relaxation of muscle spasms
1. Prevention or retardation of disuse atrophy
1. Increasing local blood circulation
1. Maintaining or increasing range of motion
1. Muscle re-education

The RT300 pediatric version is intended for population ages 4 to 12 years. The RT300 is intended for use with a surface electrical stimulation garment for population ages 12 and above.

The RT300 is for prescription use only.

The Indications for Use described in the numbered items above are not identical to the predicate device, however, the differences do not alter the intended

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therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for general rehabilitation.

(6) Technological Characteristics

The function of the RT300 is the same as the predicate devices however there are certain technological similarities and differences as described below:

Technology	RT300	RT300 predicate:K090750	Xcite predicateK160614
Ergometer	Cycle ergometer	Cycle ergometer	No ergometer
Powersource(energyused)	Mains power andrechargeable battery forRT50 stimulators	Mains power andrechargeable battery forRT50 stimulators	Mains power andrechargeablebattery for RT60and RT50stimulators
Controller	Based on Tablet PCrunning customsoftware.	Based on Pocket PCrunning customsoftware.	Based on tabletPC runningcustom software.
Stimulator(energydelivered)	Built in AC mainspowered 0-140mA 6channel chargebalanced stimulator.Optionally, the RT300can accommodate two6-channel stimulators fora total of 12 channels.	Built in AC mainspowered 0-140mA 6channel chargebalanced stimulator.	Up to 2 DCpowered 0-140mA6 channel chargebalancedstimulators("RT60"s).
Stimulationpulse width	Up to 3,000usec	Up to 500usec	Up to 500usec
Additionalstimulationchannels	Up to 5 additionalwireless batterypowered stimulationchannels delivering 0-140mA charge balancedstimulation.	Up to 5 additionalwireless batterypowered stimulationchannels delivering 0-140mA chargebalanced stimulation.	Up to 4 additionalwireless batterypoweredstimulationchannelsdelivering 0-140mA chargebalancedstimulation.
Standalonestimulationmode	Wireless batterypowered stimulationchannels may be usedin standalone modewithout the cycleergometer.	Wireless batterypowered stimulationchannels may be usedin standalone modewithout the cycleergometer.	Always used instandalonestimulation mode.
Stimwear	Stimwear garment	Stimwear garment	No stimwear

Image /page/5/Picture/6 description: The image shows the logo for RTI International. The logo consists of the letters "RTI" in a teal sans-serif font. To the left of the letters are two curved teal lines that form a vertical oval shape. The logo is simple and modern.

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Technology	RT300	RT300 predicate:K090750	Xcite predicateK160614
garment	incorporating electrodesavailable for lowerextremity cycling, ages12 and above.	incorporating electrodesavailable for lowerextremity cycling, ages12 and above.	garment.
Musclesavailableforstimulation	Quadriceps, hamstrings,gluteals, gastroc,anterior tibialis,shoulder, biceps,triceps, anterior,posterior and middledeltoid, wrist, grasp,abdominals, erectorspinae.	Quadriceps,hamstrings, gluteals,gastroc, anterior tibialis,shoulder, biceps,triceps, anterior,posterior and middledeltoid, wrist, grasp,abdominals, erectorspinae.	Quadriceps,hamstrings,gluteals, gastroc,anterior tibialis,shoulder, biceps,triceps, anterior,posterior andmiddle deltoid,wrist extensorsand flexors, grasp,abdominals,erector spinae.
Flywheel	Uses leg / arm crankmotor to create flywheeleffect with reducedweight and space.	Uses leg / arm crankmotor to create flywheeleffect with reducedweight and space.	N/A
Seating	Allows user to remain intheir own seating, e.gwheelchair eliminatingthe need for transfer.	Allows user to remain intheir own seating, e.gwheelchair eliminatingthe need for transfer.	N/A
Passivecycling	Utilizes motor to provideassistance duringpassive cycling.	Utilizes motor toprovide assistanceduring passive cycling.	N/A
Databaseinterface	Utilizes databaseinterface for storage andretrieval of patienttherapy settings andstorage of session logs.	Utilizes databaseinterface for storageand retrieval of patienttherapy settings andstorage of session logs.	Utilizes databaseinterface forstorage andretrieval of patienttherapy settingsand storage ofsession logs.
Motorizedarm crank	Allows active / passivearm cycling with FES	Allows active / passivearm cycling with FES	N/A
Pulseoximeterinterface	Utilize pulse and SpO2data for display,recording and alarming	Utilize pulse and SpO2data for display,recording and alarming	Utilize pulse andSpO2 data fordisplay, recordingand alarming
Bilateral orUnilateralstimulation	Uses bilateral orunilateral stimulation.	Uses bilateral orunilateral stimulation.	Uses bilateral orunilateralstimulation.

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Technology	RT300	RT300 predicate:K090750	Xcite predicateK160614
Indications	1.Relaxation of musclespasms2.Prevention orretardation of disuseatrophy3.Increasing local bloodcirculation; and4.Maintaining orincreasing range ofmotion5. Muscle re-educationThe RT300 pediatricversion is intended forpopulation ages 4 to 12years.The RT300 is intendedfor use with a surfaceelectrical stimulationgarment for populationages 12 and above.The RT300 is forprescription use only.	1.Relaxation of musclespasms2.Prevention orretardation of disuseatrophy3.Increasing local bloodcirculation; and4.Maintaining orincreasing range ofmotionThe RT300 pediatricversion is intended forpopulation ages 4 to 12years.The RT300 is intendedfor use with a surfaceelectrical stimulationgarment for populationages 12 and above.The RT300 is forprescription use only.	1.Relaxation ofmuscle spasms2.Prevention orretardation ofdisuse atrophy3.Increasing localblood circulation4.Maintaining orincreasing rangeof motion5.Muscle re-education

Table 1 Device technology comparison

(b) Performance data

Non clinical testing to determine equivalence has been primarily composed of the following tests:

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the RT300, consisting of the tablet, leg ergometer, arm ergometer, 2 RT60s and stimulation cable. The system complies with IEC 60601-1, IEC 60601-2-10, and IEC 60601-1-11 standards for safety and IEC 60601-1-2 for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices: The software for this device was considered "moderate" level

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of concern, since a failure of latent flaw in the software could directly result in minor injury to the patient or operator.

Test or procedure	Description
Review of user documentation forpredicate device	Ensure that equivalent functionality isspecified and implemented in the newdevice.
Review of 510(k) submission forpredicate device	Confirm technical specifications forcompletion of predicate details incomparison tables.
Output characteristic measurement ofnew device	Confirm technical specifications forcompletion of new device details incomparison tables.
Conduct of system testing	Conduct system testing to verifyperformance to specification.

Clinical Testing

Clinical testing consisted of a multi-arm study with patients serving as their own control. The protocol's objective was to evaluate the safety and effectiveness of external functional neuromuscular stimulators operating at high pulse widths (500-3000 usec) stimulation. Subjects used multi-muscle, high frequency, and pulse width with the RT300 stimulator to generate neuromuscular activity. Subjects were evaluated for 4 interventions; Cycling with Lower Extremity NMES (NeuroMuscular Electrical Stimulation), Lower Extremity NMES, Trunk NMES, and Upper Extremity NMES. Additionally pediatric subjects were assessed

Cycling with Lower Extremity NMES

Intervention:

Fifteen patients (15) undertook activity based therapy using NMES during cvcling on an RT300 cycle.

Primary safety endpoint:

The primary safety endpoint consisted of treatment-related adverse reactions, normal erythema, blancheable erythema, muscle strain, joint strain, or fracture.

Effectiveness

The primary endpoint for the Cycling intervention focused on the risk assessment of cycling with high pulse width (500-3000 usec, with 8 patients receiving the maximum of 3000us) stimulation. Fifteen (15) patients completed 434 cycling sessions - 3 had normal erythema and none had an adverse reaction, blancheable erythema, muscle strain, joint strain nor fracture. Therefore this intervention met its primary endpoint with no adverse reactions or other injuries.

Lower Extremity NMES

Intervention:

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Thirty-three (33) patients undertook activity based therapy using NMES during the following motor tasks: lying supine, sit to stand, standing.

Primary effectiveness endpoint:

Clinically significant improvements in functional outcome measures. These measures included evaluation using the Adult Neuromuscular Recovery Scale (NRS), Berg Balance Scale, Biodex Dynamometer Torque test for Force Production from Maximum Voluntary Contractions (MVC), Overground Standing Test.

Primary safety endpoint:

The primary safety endpoint consisted of treatment-related adverse reactions, normal erythema, blancheable erythema, muscle strain, joint strain, or fracture.

Effectiveness

The primary endpoint for the Lower Extremity intervention focused on the changes to the outcome measures after intervention with high pulse width (500-3000 usec, with 10 patients receiving the maximum of 3000us). Twenty-three (23) patients increased their NRS by 16% (average pre assessment score of 5.43 to average post of 6.45), their lower extremity NRS by 11% (3.27 to 3.71); 15 patients increased their Berg scores by 47% (average pre assessment score of 6.8 to average post of 10); MVC torque increased for 8 lower extremity muscle groups (Right and Left knee extensors, Right and Left plantarflexors and Right and Left dorsiflexors) in an average of 9 patients by a minimum of 152% (average torque in Nm at pre assessment of 3.5 to a post assessment of 7.13) increase in right plantarflexor torque output to a maximum 3796% (average torque in Nm at pre assessment of 0.1 to a post of 21.87) for left plantarflexor output, and 8 patients increased their Overground Standing Test times by 7108% (average pre time standing of 0 to average post time of 300 seconds). Therefore this intervention met its primary endpoint of an increase in all outcome measures.

Safetv

After 920 sessions twenty-seven (27) patients experienced no adverse reactions, 8 patients experienced normal erythema. 1 patient experienced blancheable erythema and none experienced muscle strain, joint strain nor fracture.

Trunk NMES

Intervention:

Thirteen (13) patients undertook activity based therapy using NMES during the following motor tasks: sit, sit up and reverse sit up.

Primary effectiveness endpoint:

Clinically significant improvements in functional outcome measures. These measures included evaluation using the Adult Neuromuscular Recovery Scale

Image /page/9/Picture/14 description: The image shows the logo for RTI International. The logo consists of the letters "RTI" in a teal color, with a stylized teal line to the left of the letters. The line is curved, resembling a stylized "K" shape.

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(NRS), Berg Balance Scale, Modified Functional Reach, Independent Sitting, and Trunk Scale.

Primary safety endpoint:

The primary safety endpoint consisted of treatment-related adverse reactions, normal erythema, blancheable erythema, muscle strain, joint strain, or fracture.

Effectiveness

The primary endpoint for the Lower Extremity intervention focused on the changes to the outcome measures after intervention with high pulse width (500-3000 usec with 2 patients receiving the maximum of 3000us) stimulation. Eleven (11) patients increased their NRS by 18% (average pre assessment score of 5.26 to average post of 5.81), 5 patients increased their Berg scores by 50% (average pre assessment score of 9 to average post of 14); Modified reach scale increased 9 patients by 196% (average reach in inches at pre assessment of 6.45 to a post assessment of 18): Independent Sitting times increased in 3 patients 26583% (pre assessment time of 0 seconds to a post of 600 seconds); Trunk scale increased in 2 patients by 180% (pre assessment score of 0 to a post of 4). Therefore this intervention met its primary endpoint of an increase in all outcome measures.

Safety

After 172 sessions ten (10) patients experienced no adverse reactions, 3 patients experienced normal erythema. 1 patient experienced blancheable erythema and none experienced muscle strain, joint strain nor fracture.

Upper Extremity NMES

Intervention:

Fourteen (14) patients undertook activity based therapy using NMES during different motor tasks including reaching, grasping, pressing overhead, manipulating materials, and opening a door.

Primary effectiveness endpoint:

Clinically significant improvements in functional outcome measures. These measures included evaluation using the Adult Neuromuscular Recovery Scale (NRS), Modified Functional Reach, Bilateral Upper Extremity Basic Strength, and Modified Ashworth Upper Extremity scale.

Primary safety endpoint:

The primary safety endpoint consisted of treatment-related adverse reactions, normal erythema, blancheable erythema, muscle strain, joint strain, or fracture.

Effectiveness

The primary endpoint for the Upper Extremity intervention focused on the outcome measures after intervention with high pulse width (500-3000 usec with 1

Image /page/10/Picture/16 description: The image shows the logo for RTI International. The logo consists of the letters "RTI" in a sans-serif font, stacked vertically. To the left of the letters is a curved line that resembles a parenthesis. The color of the logo is a light blue.

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patient receiving the maximum of 3000us) stimulation. Eleven (11) patients increased their NRS by 8% (average pre assessment score of 3.91 to average post of 4.08), Modified reach scale increased in 4 patients by 122% (average reach in inches at pre assessment of 1.5 to a post assessment of 5.8); Bilateral Upper Extremity Basic Strength increased in 3 patients by 8% (pre assessment scale 2 to 2.1 post assessment) and Modified Ashworth Upper Extremity scale increased in 3 patients by 3%. Therefore this intervention met its primary endpoint of an increase in all outcome measures.

Safety

After 65 sessions seven (7) patients experienced no adverse reactions, 8 patients experienced normal erythema, and none experienced blancheable erythema, muscle strain, joint strain nor fracture.

Pediatric NMES

Intervention:

8 (eight) patients between the ages of 2 and 13 yrs old undertook activity based therapy for the upper, trunk and lower extremities using NMES during the different motor tasks (eg. reaching, grasping, standing).

Primary effectiveness endpoint:

Clinically significant improvements in functional outcome measures. These measures included evaluation using the Pediatric Neuromuscular Recovery Scale (NRS) and Segmental Assessment of Trunk Control (SATCo),

Primary safety endpoint:

The primary safety endpoint consisted of treatment-related adverse reactions, normal erythema, blancheable erythema, muscle strain, joint strain, or fracture.

Effectiveness

The primary endpoint for the Lower Extremity intervention focused on the outcome measures after intervention with high pulse width (500-1000 usec with all 8 patients receiving the maximum of 1000us) stimulation. Four (4) patients increased their NRS by 88% (average pre assessment score of 2.38 to average post of 4.13) and 3 patients increased their SATCo by 35% (pre assessment score of 8 to a post of 10.7)

Safetv

After 324 sessions 8 patients experienced no adverse reactions, 6 patients experienced normal erythema, and none experienced blancheable erythema, muscle strain, joint strain nor fracture.

Summary

Image /page/11/Picture/15 description: The image shows the logo for RTI International. The logo consists of the letters "RTI" in a teal sans-serif font. To the left of the letters are two curved teal lines that form a stylized abstract shape. The logo is simple and modern in design.

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Based on the clinical performance as documented in the clinical testing, the RT300 was found to have a safety and effectiveness profile that is similar to the predicate device

RTI concludes that:

The RT300 has the same intended use as the RT300 predicate device.

The RT300 with available wider stimulation pulses utilizes the same stimulators and control system as the predicate device including controller, stimulators, motor controller and drive assembly. The different technological characteristics do not raise new questions of safety and effectiveness.

In conclusion, RTI's clinical testing has demonstrated that the RT300 is as safe and effective as the predicate devices.

Image /page/12/Picture/7 description: The image shows the logo for RTI International. The logo features the letters "RTI" in a sans-serif font, with the "R" and "I" in a darker shade of blue than the "T". To the left of the letters, there are two curved lines that resemble a stylized "X". The overall design is simple and modern.

Wide pulse width 510(k) submission					Project	R&D
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Regulation Number and Section

§ 882.5810 External functional neuromuscular stimulator.

(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).