Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Maintaining or increasing range of motion
The RT300-SP (pediatric version), is intended for population ages 4 to 12 years.

Device Description

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

a motorized cycle ergometer (RTI part number SA100047 for adults and 1 SA100044 for children)
an FES controller / stimulator (RTI part number SA100090)
a bilateral and / or unilateral stimulation cable which connects the controller / stimulator to cutaneous electrodes (RTI part number SA100091)
cutaneous electrodes (up to 12 electrodes for up to 6 stimulation channels and 10 muscle groups, RTI part number FA100015)
an interface to a remote database for the storage and retrieval of therapy settings and the storage of therapy session logs
an optional motorized arm crank (RTI part number PP102663)
an interface to a pulse oximeter for the display and recording of pulse and SpO2 levels and provision of alarming based on the data.

This system allows a person with impaired lower extremity movement to undertake cycle ergometry both actively (utilizing FES evoked lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor).

AI/ML Overview

The provided document, K071486 for the RT300-S and RT300-SP FES cycle ergometer, describes a submission for substantial equivalence to a predicate device (K071113). The focus of this submission is to demonstrate that the new device is as safe and effective as the predicate, rather than establishing de novo performance criteria against a disease condition.

Here's an analysis of the acceptance criteria and study information, addressing your specific points:

1. A table of acceptance criteria and the reported device performance

Based on the submission, the acceptance criteria are primarily framed around demonstrating substantial equivalence to the predicate device (K071113). The reported device performance is presented as matching or being equivalent to the predicate's performance and technical specifications.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Same Intended Use as Predicate	"The RT300-S has the same intended use as the predicate device."
Same Output Characteristics as Predicate	"The RT300-S has the same output characteristics as the predicate device."
No New Questions of Safety and Effectiveness due to Technological Differences	"The different technological characteristics do not raise new questions of safety and effectiveness." (Specifically regarding the addition of a unilateral stimulation cable, which was the primary technological difference addressed by performance testing.)
Performance to Specification (System Testing)	"Conduct system testing to verify performance to specification." (No specific quantitative metrics for "specification" are provided, but the conclusion is that it passed.)
Unilateral Stimulation Mode Validation	"The unilateral stimulation mode was validated with five able bodied individuals." (The outcome is implied to be successful, demonstrating safety and effectiveness of this new mode.)
Overall Safety and Effectiveness	"RTI's clinical and non clinical testing has demonstrated that the RT300-S is as safe and effective as the predicate device."

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

Test Set Sample Size:
- Clinical Testing for Unilateral Stimulation Mode: 5 individuals.
- Non-clinical testing (System testing, Output characteristics, etc.): No specific sample size of devices or test repetitions is provided beyond "system testing" and "output characteristic measurement of new device."
Data Provenance: Not explicitly stated, however, the clinical test involved "able bodied individuals," suggesting it was prospective testing conducted by Restorative Therapies Inc. (RTI) as part of their development process. No information on country of origin is given.

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

Number of Experts: Not applicable/not specified. The testing described is primarily technical and a small-scale usability/safety validation rather than a diagnostic performance study requiring expert ground truth interpretation.
Qualifications of Experts: Not applicable/not specified.

4. Adjudication method for the test set

Adjudication Method: Not applicable. The testing described (e.g., output characteristics, system testing, unilateral stimulation mode validation) does not involve adjudication by multiple experts, as it is not a comparative diagnostic or interpretative study.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission focuses on comparing the technical and safety aspects of a new device to an existing predicate device, not on assessing human reader performance with or without AI assistance.

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

Standalone Performance: Not applicable. The RT300-S is a medical device, an FES cycle ergometer, not an AI algorithm. Its performance is inherent to its physical and functional operation, which was tested.

7. The type of ground truth used

Ground Truth: For the "unilateral stimulation mode" testing, the "ground truth" would likely be the direct observation of appropriate muscle stimulation and user experience in the "able bodied individuals," confirming the mode functions as intended without adverse effects. For non-clinical tests, the ground truth would be established by engineering specifications, calibration standards, and direct measurements of the device's output. There is no mention of pathology, outcomes data, or expert consensus in the context of diagnostic interpretation.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This device is an FES cycle ergometer, not a machine learning model that requires a training set.

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

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary

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K071486

RT300-S Summary of Safety and Effectiveness

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

SEP 1 0 2007

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

Phone: 800 609-9166

Prepared on August 29th, 2007.

(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-S, RT300-SP (FES cycle ergometer) Common name: Powered Muscle Stimulator Classification name: Powered Muscle Stimulator

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

RESTORATIVE THERAPIES, INC. product: "RT300-S", K071113, a class 2 device

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

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

a motorized cycle ergometer (RTI part number SA100047 for adults and 1 SA100044 for children)
2 an FES controller / stimulator (RTI part number SA100090)
3 a bilateral and / or unilateral stimulation cable which connects the controller / stimulator to cutaneous electrodes (RTI part number SA100091)
cutaneous electrodes (up to 12 electrodes for up to 6 stimulation channels র্ব and 10 muscle groups, RTI part number FA100015)
an interface to a remote database for the storage and retrieval of therapy 5 settings and the storage of therapy session logs
6 an optional motorized arm crank (RTI part number PP102663)
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.

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

The RT300-S (adult version) and RT300-SP (pediatric version) are 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 RT300-SP (pediatric version), is intended for population ages 4 to 12 years.

(6) Technological Characteristics

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

Technology	RT300-S	Predicate K071113
Power source (energy used)	Mains power	Mains power
Controller	Based on Pocket PC running custom software.	Based on Pocket PC running custom software.
Stimulator (energy delivered)	0-140mA charge balanced stimulator	0-140mA charge balanced stimulator
Flywheel	Uses motor to create flywheel effect with reduced weight and space.	Uses motor to create flywheel effect with reduced weight and space.
Seating	Allows user to remain in their own seating, e.g wheelchair eliminating the need for transfer.	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 without FES	Allows active / passive arm cycling without FES
Pulse oximeter interface	Utilize pulse and SpO2	Utilize pulse and SpO2

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	data for display, recording and alarming	data for display, recording and alarming
Bilateral or Unilateral stimulation	Uses bilateral or unilateral stimulation cables.	Uses bilateral stimulation cable.

(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 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 Test	Description
Testing the unilateral stimulation mode	The unilateral stimulation mode wasvalidated with five able bodiedindividuals.

RTI concludes that:

The RT300-S has the same intended use as the predicate device. The RT300-S has the same output characteristics as the predicate device. The different technological characteristics do not raise new questions of safety and effectiveness. The safety and effectiveness of providing both bilateral and unilateral stimulation has been demonstrated over the development period of the RT300-S.

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

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Restorative Therapies, Inc. % Mr. Andrew Barriskill CEO 907 South Lakewood Avenue Baltimore, MD 21224

SEP 1 0 2007

RE: K071486

Trade/Device Name: RT300-S and RT300-SP FES Cycle Ergometer Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: II Product Code: GZI Dated: August 24, 2007 Received: August 27, 2007

Dear Dr. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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

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Page 2 - Mr. Andrew Barriskill

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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address: http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely your Mark N. Melkerson

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): K071486

Device Name: RT300-S and RT300-SP

Indications For Use:

The RT300-S (adult version) and RT300-SP (pediatric version) are 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 RT300-SP (pediatric version), is intended for population ages 4 to 12 years.

Prescription Use × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Polo Vlar

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number `/ko1/94

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).