Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Maintaining or increasing range of motion
The RT200 is intended for use with a surface electrical stimulation garment for population ages 12 and above.
The RT200 is for prescription use only.

Device Description

The RT200 is a Functional Electrical Stimulation (FES) recumbent elliptical ergometer which is composed of:

a motorized elliptical ergometer (RTI part number SA110444)
an FES controller with built in 6 channel stimulator (RTI part number SA109413)
up to 5 additional wireless single channel stimulators (RTI part number FA106897)
a stimulation cable which connects the controller / stimulator to cutaneous electrodes
cutaneous electrodes (up to 22 electrodes for up to 11 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 stimwear 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 recumbent elliptical ergometry both actively (utilizing FES evoked upper or lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor).

AI/ML Overview

Here's an analysis of the provided text regarding the RT200 device, focusing on its acceptance criteria and supporting studies:

Acceptance Criteria and Device Performance

The submission for the RT200 does not explicitly list quantitative acceptance criteria in the typical sense of metrics like sensitivity, specificity, or accuracy with threshold values. Instead, its acceptance appears to be based on demonstrating substantial equivalence to predicate devices (RT300 and ERGYS). The "performance data" section focuses on showing that the RT200 has equivalent functionality and characteristics to these predicates.

The core "acceptance criteria" can be inferred from the claims made for substantial equivalence, which are essentially that the RT200 performs the same as the predicate devices for its intended use.

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (Summary)
Same Intended Use as Predicate Devices	RT200 has the same intended use as the RT300 predicate.
Same Output Characteristics as Predicate Devices	RT200 has the same output characteristics as the predicate device (RT300).
Same Control System as Predicate Devices	RT200 utilizes the same control system as the predicate device (RT300).
Different Technological Characteristics Do Not Raise New Safety/Effectiveness Questions	RTI concludes this after non-clinical and clinical testing.
As Safe and Effective as Predicate Devices	RTI's clinical and non-clinical testing demonstrated this.

Detailed Study Information:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: "seven SCI individuals" (Spinal Cord Injury).
- Data Provenance: Not explicitly stated, but given the US submission, it's highly likely the study was conducted in the US. It's also not specified if it was retrospective or prospective, though clinical validation studies are typically prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The study description is very brief and does not detail how "validation" was determined in terms of expert assessment or ground truth establishment.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. The document describes a clinical "validation" study but offers no details on how outcomes were adjudicated or if multiple expert opinions were reconciled.
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 diagnostic device. The RT200 is a physical therapy device (Functional Electrical Stimulation elliptical ergometer). Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not an algorithm-only device. The RT200 is a medical device that requires human interaction (prescription, setup, patient use, and monitoring). It is not a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies that the validation was based on the RT200 performing "as intended" for general rehabilitation purposes (relaxation of muscle spasms, prevention of disuse atrophy, increasing local blood circulation, maintaining/increasing range of motion). However, the specific ground truth used to assess these outcomes in the clinical validation with the seven SCI individuals is not detailed. It could have been physician assessments, functional outcome measures, or physiological measurements, but the document does not specify.
The sample size for the training set:
- This information is not applicable/not provided. The RT200 is a physical therapy device, not a machine learning or AI-driven system that would have a "training set" in the computational sense. Its development involved engineering design, manufacturing, and testing against specifications and predicate functionalities, not data-driven model training.
How the ground truth for the training set was established:
- This question is not applicable as there is no "training set" in the context of this device.

Summary

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K!03370
APR - 5 2011

RT200 Summary of Safety and Effectiveness

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

Andrew Barriskill Restorative Therapies Inc 907 South Lakewood Ave Baltimore, MD 21224

Phone: 800 609-9166

Prepared on March 5, 2010.

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

RT200 (FES elliptical ergometer) Proprietary name: Powered Muscle Stimulator Common name: Classification name: External Functional Neuromuscular Stimulator

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

RESTORATIVE THERAPIES, INC. product: "RT300", K090750, a class 2 device

THERAPEUTIC ALLIANCES, INC. product: "ERGYS", K841112, a class 2 device. Relates to seat only.

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

The RT200 is a Functional Electrical Stimulation (FES) recumbent elliptical ergometer which is composed of:

a motorized elliptical ergometer (RTI part number SA110444) ←
an FES controller with built in 6 channel stimulator (RTI part number যে SA109413)
up to 5 additional wireless single channel stimulators (RTI part number ന FA106897)
a stimulation cable which connects the controller / stimulator to cutaneous ব electrodes
cutaneous electrodes (up to 22 electrodes for up to 11 stimulation channels) 5
an interface to a remote database for the storage and retrieval of therapy റ settings and the storage of therapy session logs

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7 an interface to a pulse oximeter for the display and recording of pulse and SpO2 levels and provision of alarming based on the data
ထ a stimwear 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 recumbent elliptical ergometry both actively (utilizing FES evoked upper or lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor).

(5) Statement of the intended use of the device:

The RT200 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

The RT200 is intended for use with a surface electrical stimulation garment for population ages 12 and above.

The RT200 is for prescription use only.

(6) Technological Characteristics

The function of the RT200 is the same as the predicate devices however there are certain technological similarities and differences as described below:

Technology	RT200	RT300 predicate: K090750
Ergometer	Recumbent elliptical ergometer	Cycle ergometer
Power source(energy used)	Mains power and	Mains power and
	rechargeable battery for RT50stimulators	rechargeable battery for RT50stimulators
Controller	Based on Pocket PC runningcustom software.	Based on Pocket PC runningcustom software.
Stimulator(energydelivered)	Built in AC mains powered 0-140mA 6 channel charge	Built in AC mains powered 0-140mA 6 channel charge
	balanced stimulator.	balanced stimulator.
Additionalstimulationchannels	Up to 5 additional wirelessbattery powered stimulationchannels delivering 0-140mAcharge balanced stimulation.	Up to 5 additional wirelessbattery powered stimulationchannels delivering 0-140mAcharge balanced stimulation.
Stand alonestimulationmode	Wireless battery poweredstimulation channels may beused in stand alone mode without the cycle ergometer.	Wireless battery poweredstimulation channels may beused in stand alone mode without the cycle ergometer.
Stimweargarment	Stimwear garmentincorporating electrodes	Stimwear garmentincorporating electrodes

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Technology	RT200	RT300 predicate: K090750
	available for lower extremity cycling, ages 12 and above.	available for lower extremity cycling, ages 12 and above.
Muscles available for stimulation	Quadriceps, hamstrings, gluteals, gastroc, anterior tibialis, shoulder, biceps, triceps, anterior, posterior and middle deltoid, wrist, grasp, abdominals, erector spinae.	Quadriceps, hamstrings, gluteals, gastroc, anterior tibialis, shoulder, biceps, triceps, anterior, posterior and middle deltoid, wrist, grasp, abdominals, erector spinae.
Flywheel	Uses leg / arm crank motor to create flywheel effect with reduced weight and space.	Uses leg / arm crank motor to create flywheel effect with reduced weight and space.
Seating	Utilizes built in seat as per K841112.	Allows user to remain in their own seating, e.g wheelchair eliminating the need for transfer.
Passive cycling	Utilizes motor to provide assistance during passive cycling.	Utilizes motor to provide assistance during passive cycling.
Database interface	Utilizes database interface for storage and retrieval of patient therapy settings and storage of session logs.	Utilizes database interface for storage and retrieval of patient therapy settings and storage of session logs.
Motorized arm crank	Allows active / passive arm cycling with FES. Arm crank is mechanically linked to the leg crank for simultaneous use.	Allows active / passive arm cycling with FES
Pulse oximeter interface	Utilize pulse and SpO2 data for display, recording and alarming	Utilize pulse and SpO2 data for display, recording and alarming
Bilateral or Unilateral stimulation	Uses bilateral or unilateral stimulation cables.	Uses bilateral or unilateral stimulation cables.

Table 1 Device technology comparison

(b) Performance data

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

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 in

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Test or procedure	Description
	comparison 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 Test	Description
Testing the RT200 recumbent ellipticalergometer and simultaneous upper andlower extremity stimulation.	The RT200 with 5 additional RT50stimulation channels was validated withseven SCI individuals.

RTI concludes that:

The RT200 has the same intended use as the RT300 predicate device.

The RT200 has the same output characteristics as the predicate device. The RT200 utilizes the same control system as the predicate device including controller, motor controller and drive assembly. The different technological characteristics do not raise new questions of safety and effectiveness.

In conclusion, RTI's clinical and non-clinical testing has demonstrated that the RT200 is as safe and effective as the predicate devices.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines forming its body and wings. The eagle is facing right and slightly upward. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Restorative Therapies Inc % Mr. Andrew Barriskill 907 S. Lakewood St Baltimore, MD 21224

APR - 5 2011

Re: K103370

Trade Name: RT200 (FES recumbent elliptical ergometer) Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: Class II Product Code: GZI Dated: March 8, 2011 Received: March 9, 2011

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Mr. Andrew Barriskill

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Q.k. Thomsen for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K103370

RT200 functional electrical stimulation elliptical ergometer Device Name:

Indications for use:

The RT200 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

The RT200 is intended for use with a surface electrical stimulation garment for population ages 12 and above.

Prescription Use X (Part 21 CFR 801 Subpart D)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number_

K103370

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).