(130 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
- Muscle re-education
The MyoCycle is a stationary Functional electrical stimulation (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 20 cutaneous electrodes for 10 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 has four different configurations:
- Pro – allows for multiple users by storing unique user data that can be accessed by a unique user identification code; extended FES parameter adjustability; up to six channels of stimulation
- Home – only stores data for one user; limited FES parameter adjustability; up to six channels of stimulation
- Pro Plus (+) – same as Pro but allows for up to ten channels of stimulation and uses patient cabling with additional leads
- Home Plus (+) – same as Home but allows for up to ten channels of stimulation and uses patient cabling with additional leads
The provided document is an FDA 510(k) clearance letter for the MyoCycle MC-2 device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, reported device performance metrics (numerical results), details about a test set (sample size, provenance), expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance data.
The document primarily focuses on demonstrating substantial equivalence through:
- Comparison of Indications for Use: Showing the MyoCycle MC-2 has substantially equivalent indications to the predicate device, with an added "muscle re-education" indication that is standard for this type of device and does not raise new safety/effectiveness questions.
- Comparison of Technological Characteristics: Highlighting similarities and minor differences (e.g., increased stimulation channels, wider parameter range, larger touchscreen, wireless communication, database interface) that do not raise new safety/effectiveness questions.
- Performance Data (Bench Testing): Stating that testing was conducted to ensure equivalent functionality and verify performance to specifications, primarily through a review of documentation and bench testing against recognized consensus standards (e.g., electrical safety, EMC, usability).
Therefore, I cannot populate most of the requested sections as the information is not present in the provided text.
Here's what can be extracted based on the document:
Acceptance Criteria and Study Details for MyoCycle MC-2
The FDA 510(k) submission for the MyoCycle MC-2 primarily relies on demonstrating substantial equivalence to a predicate device (MyoCycle MC-HP-1, K170132) rather than presenting new clinical performance data with numeric acceptance criteria for specific outcomes. The "performance data" referred to in the document pertains to bench testing against recognized consensus standards to ensure safety and functionality, not a clinical study to evaluate device effectiveness in patients.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes no specific quantitative acceptance criteria or reported device performance metrics in a clinical context (e.g., "device achieved X% accuracy," "device improved range of motion by Y degrees"). Instead, the "acceptance criteria" are implied to be the successful demonstration of:
- Substantially equivalent Indications For Use.
- Similar technological characteristics that do not raise new questions of safety or effectiveness.
- Compliance with recognized consensus standards for device safety and electrical performance.
| Acceptance Criteria Category | Reported Device Performance (as per document) |
|---|---|
| Indications for Use Equivalence | "The MyoCycle MC-2 device's Indications for Use (IFU) Statement is substantially equivalent to that of the predicate device... addition of this indication... does not raise any new questions of safety and effectiveness." |
| Technological Characteristics Equivalence | "The MyoCycle MC-2 has similar technological characteristics and output specifications to those of the predicate device... The different characteristics and specifications do not raise new questions of safety and effectiveness." |
| Safety and Functional Performance | "MYOLYN's non-clinical testing, including bench testing against recognized consensus standards, have demonstrated that the MC-2 device is as safe and effective as the predicate device and is therefore substantially equivalent." |
| Stimulator Output | Output characteristic measurement of new device confirmed technical specifications: 0-140 mA charge balanced stimulator (predicate: 0-126 mA). |
| Compliance with Standards | System testing made general use of recognized consensus standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, 60601-1-6, 60601-1-11, 60601-2-10). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a test set in the conventional sense of a patient-based clinical study. The "testing" mentioned is primarily non-clinical bench testing and review of documentation. Therefore, information on sample size and data provenance for a clinical test set is not provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable, as no clinical test set requiring expert ground truth or adjudication is described.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not mentioned or described in the provided document. The submission focuses on substantial equivalence based on technological characteristics and bench testing, not on comparative clinical effectiveness with human readers/users.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. The MyoCycle MC-2 is a physical medical device (an FES cycle ergometer) rather than a software algorithm intended for standalone diagnostic or interpretive performance. Its functionality is tied to its interaction with a user.
7. The Type of Ground Truth Used
For the bench testing and design verification, the "ground truth" would be established by the specifications defined for the device and the requirements of the recognized consensus standards. For example, an electrical safety standard dictates specific performance criteria that the device must meet, and this standard serves as the "ground truth" for compliance. There is no mention of patient-level "ground truth" (e.g., pathology, outcomes data) for clinical efficacy.
8. The Sample Size for the Training Set
Not applicable. The document describes a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is described.
§ 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).