(237 days)
MYNDMOVE is an electrical stimulation device indicated for the following uses:
Functional Electrical Stimulation (FES)
Improvement of ann and hand functions and active range of motion in patients with hemplegia due to stroke or upper limb paralysis due to C3-T1 spinal cord injury.
NeuroMuscular Electrical Stimulation (NMES)
· Maintenance and/or increase of arm and hand range of motion
- · Prevention and/or retardation of disuse atrophy
- · Increase in local blood circulation
- · Reduction of muscle spasm
· Re-education of muscles.
Myddlove therapy can only be administered by Occupational or Physical Therapy professionals that have completed MyndMove training by Mynd Tec on the use of the MyndMove System.
The MyndMove 2.0 System is a neuromodulation device that delivers short electrical pulses to stimulate muscle contractions and enhance motor recovery following Stroke or Spinal Cord Injury. The MyndMove system comprises the Stimulator device, stimulation electrodes and cables, hand and foot switches, and integrated software. The MyndMove 2.0 Functional Electrical Stimulator is an eight-channel device with a touch screen user interface (UI). The Stimulator software allows the User to choose from a number of pre-programmed stimulation protocols, to customize the stimulation intensities for each patient, and to document the treatments provided.
Each MyndMove Stimulator is connected, via an IEEE 802.11 a/b/q/n wireless radio adapter, to a cloud-based backend data management system. The primary function of the backend is to manage the various elements of the MyndMove ecosystem including but not limited to patient unique IDs and prescriptions, therapist profiles and stimulation protocols. MyndMove 2.0 Therapy can only be administered by trained MyndMove Therapy professionals (TMMT) with assigned Therapist Log-In IDs. TMMTs are Occupational or Physical Therapy professionals that have completed MyndMove training by MyndTec on the use of the MyndMove system.
MyndMove 2.0 uses surface electrical stimulation to produce muscle contractions in different combinations to achieve a wide range of reaching and grasping functions. To achieve these movements, the single use electrodes are placed in various combinations on the surface of muscles in the arm and hand.
MyndMove 2.0 is based on advanced functional electrical stimulation (FES) principles designed to promote neuroplasticity by influencing the efferent and afferent pathways. Proper sequencing of the muscle contractions as per the MyndMove 2.0 protocols achieve a wide range of reaching and grasping functions. During the delivery of MyndMove 2.0 therapy, the patient executes functional tasks with assistance from the therapist and the MyndMove 2.0 device. The patient attempts to perform the movement and is then assisted to complete the movement when the therapist activates the MyndMove 2.0 stimulation protocol, which generates bursts of short electrical pulses, using surface electrodes, to produce muscle contraction. In this manner, the patient gets both efferent and afferent input as they are actively attempting move and as the arm and/or hand is moved into the instructed position. Non-damaged pathways can be activated and non-damaged areas of the central nervous system can be trained to substitute for injured areas.
The provided text is an FDA 510(k) summary for the MyndMove 2.0 device, which is an electrical stimulation device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (MyndMove K170564) rather than providing a detailed study proving the device meets general acceptance criteria in a clinical performance context.
Therefore, many of the requested details about acceptance criteria for clinical performance and specific study methodologies (like sample size for test sets, number of experts, adjudication, MRMC studies, standalone algorithm performance, and training set details) are not present in this type of regulatory submission document. This 510(k) summary focuses on technical equivalence and safety standards compliance due to minor modifications to an already cleared device.
However, I can extract information related to technical performance and safety compliance acceptance criteria, and the study (testing) that proves the device meets these criteria, based on the provided text.
Here is a breakdown of the available information:
Acceptance Criteria and Device Performance (primarily technical and safety-related):
| Acceptance Criterion (Category) | Reported Device Performance (MyndMove 2.0) |
|---|---|
| Indications for Use | Identical to predicate device (MyndMove): Functional Electrical Stimulation (FES) for improvement of arm and hand functions and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C3-T1 spinal cord injury. NeuroMuscular Electrical Stimulation (NMES) for maintenance/increase of arm/hand ROM, prevention/retardation of disuse atrophy, increase in local blood circulation, reduction of muscle spasm, and re-education of muscles. |
| Output Characteristics | Biphasic Asymmetrical Output Mode: |
- Waveform Shape: Rectangular
- Max Output Voltage (+/- 10%): Positive: 160V @ 500Ω, 2kΩ, 10kΩ; Negative: 40V @ 500Ω, 2kΩ, 10kΩ (Identical to predicate)
- Max Output Current (+/- 10%): Positive: 20mA @ 500Ω, 2kΩ, 16mA @ 10kΩ; Negative: 5mA @ 500Ω, 2kΩ, 4mA @ 10kΩ (Identical to predicate)
- Pulse Width: Positive: 150-400 µs; Negative: 600-1600 µs (Identical to predicate)
- Frequency: 1Hz or 40Hz (Identical to predicate)
- Symmetrical phases: No (Identical to predicate)
- Net Charge (per pulse): 1.85µC (Identical to predicate)
- Maximum Phase Charge: 9.02µC (Equivalent to predicate)
- Maximum Current Density (RMS) using smallest electrode: 0.93 mA/cm2 (for 1x3 cm electrode). (Meets criteria
§ 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).