RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053 by RESTORATIVE THERAPIES INC.

a motorized cycle ergometer (RTI part number SA100047 for adults and SA100044 for children)
an FES controller / stimulator (RTI part number SA100090)
a stimulation cable which connects the controller / stimulator to cutaneous electrodes (RTI part number SA100091)
cutaneous electrodes (12 electrodes for 6 stimulation channels, 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

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 text describes the RT300-S and RT300-SP Functional Electrical Stimulation (FES) cycle ergometer, its intended use, technological characteristics, and performance data submitted for 510(k) clearance.

However, the document does not provide specific acceptance criteria or an explicit study proving the device meets those criteria in the format typically used for AI/ML device evaluations. Instead, it focuses on demonstrating substantial equivalence to a predicate device (THERAPEUTIC ALLIANCES, INC. product: "ERGYS", K841112) through non-clinical and clinical testing.

Therefore, an exhaustive table of acceptance criteria and reported device performance, as well as detailed information on sample sizes, expert qualifications, and ground truth establishment, cannot be extracted directly from this document. The information provided is primarily for regulatory clearance based on equivalence, not a standalone performance study with predefined metrics.

Here's a breakdown of what can be inferred and what is missing, structured as closely as possible to your request:

RT300-S/SP Functional Electrical Stimulation Cycle Ergometer

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Equivalence)	Reported Device Performance (Summary)
Safety and Effectiveness equivalent to predicate device (ERGYS, K841112)	"RTI's clinical and non clinical testing has demonstrated that the RT300-S is as safe and effective as the predicate device."
Correct operation of system, including electrode off detection.	Confirmed during testing with able-bodied subjects.
Consistent performance across multiple devices and a remote database interface.	Demonstrated through testing of the remote database interface at a clinic with multiple RT300-S systems.
Technological characteristics do not raise new questions of safety and effectiveness.	Reviewed and concluded that differences (motorized flywheel, passive cycling assistance, database interface) do not introduce new risks, citing ongoing clinical use of motorized ergometers (without stimulation) in EU and USA.
Compliance with technical specifications.	Confirmed through output characteristic measurements and system testing.
Equivalent functionality as specified in predicate device's user documentation.	Ensured through review of predicate device documentation.
Technical specifications for predicate device confirmed.	Obtained from review of 510(k) submission for predicate device.

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

Able-bodied subjects: The number is not specified, only "able bodied subjects."
Spinal Cord Injured subjects: The number is not specified. The document states, "The RT300-S is being utilized in clinical studies involving spinal cord injured subjects," implying ongoing or past clinical use, not necessarily a discrete "test set" for this 510(k).
Clinic utilizing multiple RT300-S systems: The number of systems or specific clinics is not mentioned for the database interface testing.
Data Provenance: The document does not specify country of origin for the subject data. The studies mentioned appear to be prospective, focusing on system operation and clinical application.

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

This information is not provided. The "ground truth" seems to be based on the established safety and effectiveness of the existing predicate device and the new device's ability to operate according to specifications and perform its intended functions. There's no indication of a diagnostic "ground truth" established by an expert panel in the context of this device.

4. Adjudication method for the test set:

Not applicable/Not described. This type of adjudication (e.g., 2+1) is typically relevant for diagnostic or AI/ML evaluations where there's interpretive variation, which is not the primary focus of this submission. The evaluation is against engineering specifications and comparison to a predicate.

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. The RT300-S is a medical device for physical rehabilitation, not an AI/ML diagnostic or assistive tool for human readers/clinicians, so an MRMC study is outside the scope of this submission.

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

The RT300-S is a physical device that integrates a stimulator, controller, and ergometer. Its functions (e.g., muscle stimulation, cycling) are inherently "standalone" in the sense of the machine performing the intended action, but always with a human user. The performance data focuses on the device's operational characteristics and functional equivalence, not on an "algorithm only" performance in a diagnostic context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this 510(k) submission is implicitly the established safety and effectiveness of the predicate device and the technical specifications for the new device. The goal is to demonstrate that the RT300-S meets its technical specifications and performs its intended functions without raising new safety or effectiveness concerns compared to the predicate. The "clinical studies" mentioned with SCI subjects are used to support the safety and effectiveness aspect in real-world scenarios, but specific 'outcomes data' used as a ground truth for a quantitative metric are not detailed.

8. The sample size for the training set:

Not applicable. This document describes a medical device, not an AI/ML model for which "training sets" are typically used.

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

Not applicable, as there is no mention of a training set or AI/ML model.

Summary

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K 060032

RT300-S 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 2363 Boston St Baltimore, MD 21224

Phone: 800 609-9166

Prepared on March 81 2006.

(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:

THERAPEUTIC ALLIANCES, INC. product: "ERGYS", K841112, 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 SA100044 for children) T
an FES controller / stimulator (RTI part number SA100090) ଧ
a stimulation cable which connects the controller / stimulator to cutaneous electrodes (RTI part 3 number SA100091)
cutaneous electrodes (12 electrodes for 6 stimulation channels, RTI part number FA100015) 4
an interface to a remote database for the storage and retrieval of therapy settings and the storage 5 of therapy session logs

(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:

Relaxation of muscle spasms 1.
Prevention or retardation of disuse atrophy 2.
Increasing local blood circulation ತ
Maintaining or increasing range of motion র্য

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

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(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
Power source (energy used)	Mains power	Mains power
Controller	Based on Pocket PCrunning custom software.	Uses custom controllerrunning custom software.
Stimulator (energy delivered)	0-140mA charge balancedstimulator	0-140mA charge balancedstimulator
Flywheel	Uses motor to createflywheel effect with reducedweight and space.	Uses heavy mechanicalflywheel.
Seating	Allows user to remain intheir own seating, e.gwheelchair eliminating theneed for transfer.	Includes a dedicated seatingarrangement.
Passive cycling	Utilizes motor to provideassistance during passivecycling.	Requires manual assistanceto provide power duringpassive cycling.
Database interface	Utilizes database interfacefor storage and retrieval ofpatient therapy settings andstorage of session logs.	No database interface.

(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 for predicatedevice	Ensure that equivalent functionality is specifiedand implemented in the new device.
Review of 510(k) submission for predicatedevice	Confirm technical specifications for completionof predicate details in comparison tables
Output characteristic measurement of newdevice	Confirm technical specifications for completionof new device details in comparison tables
Conduct of system testing	Conduct system testing to verify performanceto specification.

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Clinical Test	Description
Testing with able bodied subjects	The RT300-S was tested on able bodied subjects toconfirm correct operation of the system includingcorrect detection of electrode off conditions withvarying skin impedances.
Testing with spinal cord injured subjects	The RT300-S is being utilized in clinical studiesinvolving spinal cord injured subjects.
Testing the remote database interface	The RT300-S remote database interface was testedat a clinic utilizing multiple RT300-S systems.

RTI concludes that:

The RT300-S has the same intended use as the predicate device. The RT300-S has the same ാഥ്യൂഗ്യ r he N root o had the benice. The different technological characteristics do not raise new onestions of safety and effectiveness. The safety and effectiveness of using a motor to simulate the quodions of early and enceal flywheel and provide passive cycling assistance has been extensively demonstrated in particular by the ongoing clinical use of the motorized ergometer without the stimulation component both in the European Union and in the U.S.A. The safety and effectiveness of the controller has been demonstrated over the development period of the RT300-S. The remote database enhances the safety and effectiveness of the system by ensuring that patients always commence a therapy session with their latest, accurate device settings.

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 seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2006

Restorative Therapies, Inc. c/o Mr. Andrew Barriskill CEO 2363 Boston Street Baltimore, Maryland 21224

Re: K060032

Trade/Device Name: RT300-S and RT300-SP Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: II Product Code: GZI Dated: February 14, 2006 Received: February 15, 2006

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.

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 docs not mean that FDA has made a determination that vour 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 its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Heike Leuner co

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): K060032

RT300-S and RT300-SP Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The RT300-S (adult version) and RT300-SP (pediatic version) are intended for general rehabilitation for:

Relaxation of muscle spasms a.
Prevention or retardation of disuse atrophy b.
Increasing local blood circulation C.
Maintaining or increasing range of motion ರ

The RT300-SP (pediatic version), is intended for population ages 4 to 12 years.

AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

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)

Helle Lund

Page 1 of _

Division of General, Restorative, and Neurological Devices

510(k) Number K060032

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).