(98 days)
The MyoCycle is intended for general rehabilitation for:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Maintaining or increasing range of motion
The MyoCycle is a stationary FES cycle ergometer which is composed of:
- 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
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.
§ 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).