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
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 text describes a 510(k) premarket notification for the RT300-S and RT300-SP Functional Electrical Stimulation (FES) cycle ergometers. The submission aims to demonstrate substantial equivalence to a predicate device (RT300-S, K060032). It outlines the device's technological characteristics, intended use, and the performance data gathered to support its safety and effectiveness.

However, it does not include information about acceptance criteria or a detailed study proving the device meets specific performance metrics in the way one might expect for a diagnostic or AI-driven medical device study.

The "performance data" section primarily focuses on demonstrating equivalence to the predicate device through technical reviews and system testing, rather than explicit acceptance criteria and corresponding performance metrics for new or enhanced features.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it's absent:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in the format of a table with specific thresholds for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance" is framed around demonstrating substantial equivalence to the predicate device through technological similarities and confirming the proper functioning of new features.

The "Performance data" section describes the activities undertaken to support equivalence, which are implicitly aimed at "accepting" that the new device performs as intended and is as safe and effective as the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Equivalence of specified functionality to predicate device	User documentation for the predicate device was reviewed to ensure equivalent functionality is specified and implemented in the new device.
Confirmation of technical specifications for predicate device	510(k) submission for the predicate device was reviewed to confirm technical specifications.
Confirmation of technical specifications for new device	Output characteristic measurements of the new device were performed to confirm technical specifications for comparison tables.
Verification of performance to specification (system testing)	System testing was conducted to verify performance to specification.
Validation of pulse oximeter interface functionality	The RT300-S pulse oximeter interface was validated.
No new questions of safety and effectiveness from technological differences	Safety and effectiveness of using a motor to simulate a mechanical flywheel and provide passive cycling assistance: Demonstrated by ongoing clinical use of motorized ergometer without stimulation component in EU and USA. Safety and effectiveness of the controller: Demonstrated over the development period of the RT300-S. Remote database: Enhances safety and effectiveness by ensuring patients always commence therapy with latest, accurate device settings.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: For the pulse oximeter interface validation, the test set consisted of four able-bodied individuals.
- Data Provenance: Not explicitly stated, but given the US submission, it's likely US-based. It does not specify if it was retrospective or prospective, but testing on "able-bodied individuals" suggests a prospective, controlled evaluation for that specific component. Other testing mentioned ("Review of user documentation," "Review of 510(k) submission," "Output characteristic measurement," "Conduct of system testing") does not involve a "test set" in the typical sense of patient data.
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 document describes technical evaluations and a small-scale validation for a specific interface, not studies requiring expert-established ground truth for diagnostic accuracy.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessment, which is not the primary focus of the described performance data.
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 MRMC comparative effectiveness study was done or mentioned. This type of study is relevant for AI-driven diagnostic tools, which the RT300-S/SP is not. This device is a therapy delivery system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document describes device performance in terms of its ability to function according to specifications and equivalence to a predicate, which inherently assesses its standalone operation for its intended therapeutic function. However, it's not "standalone performance" in the context of a diagnostic algorithm's output. The "system testing" and "output characteristic measurement" would fall under this category as they refer to the device's inherent operation.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For the technical tests, the "ground truth" was likely the technical specifications and expected outputs of the device based on its design and the predicate device's characteristics. For the pulse oximeter, the ground truth would be the actual physiological parameters (pulse and SpO2) of the able-bodied individuals, measured by a gold standard method if a reference was used. The document does not specify if a gold standard reference was employed for the pulse oximeter validation.
The sample size for the training set:
This information is not applicable/not provided. The RT300-S/SP is a hardware and software system for FES, not an AI or machine learning model that undergoes "training."
How the ground truth for the training set was established:
This information is not applicable/not provided as there is no mention of a training set for an AI/ML model.

Summary

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K07///3

RT300-S Summary of Safety and Effectiveness

JUL - 5 2007

(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 February 14th, 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) Powered Muscle Stimulator Common name: Classification name:Powered Muscle Stimulator

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

RESTORATIVE THERAPIES, INC. product: "RT300-S", K060032, 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 ー SA100044 for children)
an FES controller / stimulator (RTI part number SA100090) ଧ
a stimulation cable which connects the controller / stimulator to cutaneous ന electrodes (RTI part number SA100091)
cutaneous electrodes (12 electrodes for 6 stimulation channels, RTI part 4 number FA100015)
an interface to a remote database for the storage and retrieval of therapy റ 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 7 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
Power source (energyused)	Mains power	Mains power
Controller	Based on Pocket PCrunning custom software.	Based on Pocket PCrunning custom software.
Stimulator (energydelivered)	0-140mA chargebalanced stimulator	0-140mA chargebalanced stimulator
Flywheel	Uses motor to createflywheel effect withreduced weight andspace.	Uses motor to createflywheel effect withreduced weight andspace.
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.
Passive cycling	Utilizes motor to provideassistance duringpassive cycling.	Utilizes motor to provideassistance duringpassive cycling.
Database interface	Utilizes databaseinterface for storage andretrieval of patienttherapy settings andstorage of session logs.	Utilizes databaseinterface for storage andretrieval of patienttherapy settings andstorage of session logs.
Motorized arm crank	Allows active / passivearm cycling without FES	No motorized arm crank
Pulse oximeter interface	Utilize pulse and SpO2	No pulse oximeter

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I alle and the may of	data for display.	A STERNET A COLLECTION COLLECTION CONTRACT AND THE COLLECTION CONTRACT CONTRACT CARTER CONTRACT CARTER CONTRACT CONTRACT CARTER CONTRACT CARTER CONTRACT CARTER CONTRACT CARTEinterface provided
	recording and alarming

(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 pulse oximeter interface	The RT300-S pulse oximeter interfacewas validated with four 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 using a motor to simulate the predicate device's mechanical 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.

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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/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 5 2007

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

RE: K071113

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: April 19, 2007 Received: April 20, 2007

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 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 yours,

Neil R. Ogden

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): K071113

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)

Neil R. Ogle

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

Page 1 of

510(k) Number_________________________________________________________________________________________________________________________________________________________________ 112

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).