a motorized cycle ergometer
an FES controller / stimulator
a stimulation cable which connects the controller / stimulator to cutaneous electrodes (at maximum 12 cutaneous electrodes for 6 channels)
cutaneous electrodes
This system allows a person with impaired lower extremity movement to undertake cycle ergometry both actively (utilized FES evoked lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor). The electric motor inside the MyoCycle ensures that the pedals always rotate at 35 revolutions per minute (r/min) (isokinetic cycling), so it automatically assists or resists the patient, depending on the magnitude and direction of the torque applied to the crank by the patient. The system software operates in two modes:
Pro mode allows for multiple users by storing unique user data that can be accessed by a unique user identification code
Home mode only stores data for one user

AI/ML Overview

This document is a 510(k) summary for the MyoCycle Home and MyoCycle Pro devices, which are functional electrical stimulation (FES) cycle ergometers. It seeks to establish substantial equivalence to a predicate device, the RT300-S (K050036), manufactured by Restorative Therapies Inc.

Here's the breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., minimum accuracy percentages, specific thresholds for safety measurements). Instead, it describes a series of tests performed to demonstrate substantial equivalence to a predicate device, validating its safety and effectiveness. The "reported device performance" is framed in terms of meeting recognized consensus standards and demonstrating similar functionality and safety characteristics to the predicate.

Given the information, the table would look like this, extrapolating "acceptance criteria" from the performed tests and implied equivalency:

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence to Predicate Device
- Equivalent functionality specified and implemented	- "Review of user documentation for predicate device" confirmed equivalent functionality is specified and implemented in the MyoCycle.
- MyoCycle IFU Statement is substantially equivalent	- MyoCycle IFU Statement is identical to the RT300-S (K050036) for relaxation of muscle spasms, prevention/retardation of disuse atrophy, increasing local blood circulation, and maintaining/increasing range of motion.
Technical Specifications and Output Characteristics
- Technical specifications for new device confirmed	- "Output characteristic measurement of new device" confirmed technical specifications for the MyoCycle.
- Similar output characteristics to predicate device	- Stimulator delivers 0-126 mA charge balanced, compared to predicate's 0-140 mA. This difference is not stated to raise new safety/effectiveness questions. Other technological characteristics (power source, flywheel, seating, passive cycling) are similar or equivalent in function.
Performance to Specification
- Verified performance to specification	- "Conduct of system testing" verified performance to specification.
Safety and Essential Performance (Compliance with Standards)
- Compliance with IEC 60601-2-10 Ed. 2.0 (Nerve/Muscle Stimulators)	- MyoCycle met this standard.
- Compliance with AAMI ANSI ES60601-1 (General Safety/Performance)	- MyoCycle met this standard.
- Compliance with IEC 60601-1-2 Ed. 4.0 (EMC)	- MyoCycle met this standard.
- Compliance with IEC 60601-1-11 Ed. 2.0 (Home Healthcare)	- MyoCycle met this standard.
- Compliance with AAMI ANSI HA60601-1-11 (Home Healthcare)	- MyoCycle met this standard.
Usability/Operability by Intended Users
- Operable by lay operators	- Validated with five lay operators using the device with an able-bodied, simulated patient.
- Operable by clinician operators	- Validated with seven clinician operators using the device with six spinal cord injured patients.
- Operable by patient operators (without assistance)	- Validated with five spinal cord injured patients using the device without assistance.

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

The document describes several "testing" activities, primarily focused on verification and usability, rather than a traditional "test set" for an AI algorithm's performance against a ground truth.

Lay Operators Test: 5 lay operators, with an able-bodied, simulated patient. (Likely prospective, country of origin not specified but assumed US given FDA filing)
Clinician Operators Test: 7 clinician operators, with 6 spinal cord injured patients. (Likely prospective, country of origin not specified but assumed US)
Patient Operators Test: 5 spinal cord injured patients, using the device without assistance. (Likely prospective, country of origin not specified but assumed US)

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

This type of information is not applicable and not present in the document. The "testing" described is about evaluating device function, safety, and usability by various user types, not about establishing ground truth for an AI algorithm's diagnostic or predictive output. The "experts" involved are the clinician operators (7 of them), whose specific qualifications (e.g., years of experience, specific medical specialty beyond "clinician operator") are not detailed.

4. Adjudication Method for the Test Set

Not applicable as there is no specific "ground truth" to adjudicate for these functional and usability tests. The assessment would likely involve observing successful operation, gathering user feedback, and confirming adherence to operational specifications.

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 MyoCycle is an FES cycle ergometer, not an AI-powered diagnostic or assistive tool for human readers. There is no AI component described in the context of improving human reader performance.

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

Not applicable. The MyoCycle is a physical medical device (an FES cycle ergometer) that primarily relies on its hardware and embedded software for its function, not a standalone AI algorithm operating independently. While it has embedded microcontrollers running custom software, this is for controlling the mechanical and stimulation aspects of the device, not a diagnostic or predictive AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Ground truth, in the context of evaluating an AI algorithm's performance against a known reality, is not a concept explicitly applied here. The "truth" being established is the device's adherence to engineering specifications, safety standards, and its ability to be used effectively by its intended operators (lay, clinician, and patient). This is achieved through direct performance verification and observation during testing.

8. The Sample Size for the Training Set

Not applicable. The MyoCycle is not an AI system that undergoes "training" on a data set in the way a machine learning model would. Its development would involve engineering design, prototyping, and iterative testing, not data-driven training.

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

Not applicable, as there is no "training set" in the context of AI described for this device.

Summary

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Image /page/0/Picture/2 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 top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

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

April 25. 2017

Myolyn, LLC Matthew Bellman Chief Technology Officer 7731 W. Newberry Rd., Suite A-2 Gainesville, Florida 32606

Re: K170132

Trade/Device Name: Myocycle Home, Myocycle Pro Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI Dated: March 21, 2017 Received: March 23, 2017

Dear Mr. Bellman:

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 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

Carlos L. Peña, PhD, MS for 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) K170132

Device Name MyoCycle Home, MyoCycle Pro

Indications for Use (Describe)

The MyoCycle 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

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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Image /page/3/Picture/1 description: The image shows the word "MYOLYN" in a stylized font. The letters are all capitalized and in a thin, sans-serif font. The "O" in the word is replaced by a circular graphic containing a complex, branching pattern resembling a neuron or nerve cell. The overall design is clean and modern.

510(k) Summary

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

Company:	MYOLYN, LLC7731 W. Newberry. Rd., Suite A-2Gainesville, FL 32606Phone: (352) 354-2749

Contact person: Matthew Bellman, PhD Chief Technology Officer Phone: (850) 832-1842 E-mail: mjbellman@myolyn.com

Date prepared: 04-12-2017

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

Proprietary name:	MyoCycle Home, MyoCycle Pro
Common name:	Functional electrical stimulation (FES) cycle ergometer
Classification name:	External functional neuromuscular stimulator
Device class:	2
Classification product code:	GZI
Classification panel:	Neurology
Regulation number:	882.5810

(3) Identification of the legally marketed device to which the submitter claims equivalence:
Manufacturer: Restorative Therapies Inc. Product: RT300-S 510(k) number: K050036 Device class: ನ

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

The MyoCycle is a stationary FES cycle ergometer which is composed of:

1. a motorized cycle ergometer
1. an FES controller / stimulator
1. a stimulation cable which connects the controller / stimulator to cutaneous electrodes (at maximum 12 cutaneous electrodes for 6 channels)
1. cutaneous electrodes

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

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Image /page/4/Picture/1 description: The image shows the word "MYOLYN" in a stylized font. The "O" in the word is replaced by a circular graphic containing a neuron-like structure. The letters are all in uppercase and have a minimalist, geometric design. The overall design is clean and modern.

the MyoCycle ensures that the pedals always rotate at 35 revolutions per minute (r/min) (isokinetic cycling), so it automatically assists or resists the patient, depending on the magnitude and direction of the torque applied to the crank by the patient. The system software operates in two modes:

1. Pro mode allows for multiple users by storing unique user data that can be accessed by a unique user identification code
1. Home mode only stores data for one user

(5) Indications for Use Statement:

The MyoCycle's Indications for Use (IFU) Statement is substantially equivalent to that of the predicate device, the RT300-S (K050036), as described in the table below. The MyoCycle does not have the same IFU Statement as the RT300-SP (pediatric version).

MyoCycle IFU Statement	RT300-S (K050036) IFU Statement
The MyoCycle is intended for generalrehabilitation for:	The RT300-S (adult version) and RT300-SP (pediatric version) are intended for general rehabilitation for:
1. Relaxation of muscle spasms	1. Relaxation of muscle spasms
2. Prevention or retardation of disuse atrophy	2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation	3. Increasing local blood circulation
4. Maintaining or increasing range of motion	4. Maintaining or increasing range of motion
	The RT300-SP (pediatric version), is intended for population ages 4 to 12 years.

The MyoCycle is for prescription use only.

(6) Technological Characteristics

The function of the MyoCycle is substantially equivalent to the predicate device; however, there are certain technological similarities and differences, as described below:

Technology	MyoCycle	RT300-S (K050036)
Power source (energy used)	Mains power	Mains power
Controller	Uses embeddedmicrocontrollers runningcustom software	Based on Pocket PCrunning customsoftware
Stimulator (energy delivered)	0-126 mA chargebalanced stimulator	0-140 mA chargebalanced stimulator

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Image /page/5/Picture/0 description: The image shows the word "MYOLYN" in a stylized font. The letters are all in uppercase and are black. The "O" in the word is replaced by a circle containing a black neuron-like structure, adding a biological or medical theme to the design. The overall design is clean and modern.

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.g.wheelchair eliminatingthe need for transfer	Allows user to remain intheir own seating, e.g.wheelchair eliminatingthe need for transfer
Passive cycling	Utilizes motor to provideassistance duringpassive cycling	Utilizes motor to provideassistance duringpassive cycling

(b) Performance data

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.
Testing with lay operators	The MyoCycle was validated with five layoperators using the device with an ablebodied, simulated patient.
Testing with clinician operators	The MyoCycle was validated with sevenclinician operators using the device with sixspinal cord injured patients.
Testing with patient operators	The MyoCycle was validated with fivespinal cord injured patients using thedevice without assistance.

As part of the system testing described above, the MyoCycle met the following recognized consensus standards:

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Image /page/6/Picture/0 description: The image shows the word "MYOLYN" in a stylized font. The letters are all capitalized and made of thin lines. The "O" in the word is replaced by a circle containing a black neuron-like structure with branching dendrites, adding a biological or scientific element to the design.

RecognitionNumber	StandardsOrganization	Standard DesignationNumber and Date	Title of Standard
17-11	IEC	60601-2-10 Edition 2.02012-06	Medical Electrical Equipment -- Part2-10: Particular Requirements ForThe Basic Safety And EssentialPerformance Of Nerve And MuscleStimulators
19-4	AAMI ANSI	ES60601-1:2005/(R)2012 AndA1:2012	C1:2009/(R)2012 AndA2:2010/(R)2012 (Consolidated Text)Medical Electrical Equipment - Part1: General Requirements For BasicSafety And Essential Performance(IEC 60601-1:2005, MOD)
19-8	IEC	60601-1-2 Edition 4.02014-02	Medical Electrical Equipment - Part1-2: General Requirements For BasicSafety And Essential Performance -Collateral Standard: ElectromagneticDisturbances - Requirements AndTests
19-14	IEC	60601-1-11 Edition 2.02015-01	Medical Electrical Equipment - Part1-11: General Requirements ForBasic Safety And EssentialPerformance - Collateral Standard:Requirements For Medical ElectricalEquipment And Medical ElectricalSystems Used In The HomeHealthcare Environment
19-16	AAMI ANSI	HA60601-1-11:2015	Medical Electrical Equipment -- Part1-11: General Requirements ForBasic Safety And EssentialPerformance -- Collateral Standard:Requirements For Medical ElectricalEquipment And Medical ElectricalEquipment And Medical ElectricalSystems Used In The HomeHealthcare Environment (IEC 60601-1-11:2015 MOD)

MYOLYN concludes that:

The intended use of the MyoCycle is substantially equivalent to that of the predicate device.

The MyoCycle has similar output characteristics to those of the predicate device. The different technological characteristics do not raise new questions of safety and effectiveness.

MYOLYN's performance testing has demonstrated that the MyoCycle is as safe and effective for the intended use as the predicate device and is therefore substantially equivalent.

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).