(269 days)
The stimulation system is intended to provide ankle dorsiflexion or extension in individuals with foot drop and thigh muscle weakness following an upper motor neuron injury or disease.
During gait, the stimulation system sends electric stimuli to muscles in the affected leg, initiating dorsiflexion of the foot and knee extension or flexion and may thus improve the individual's gait. The stimulation system may also prevent or retard atrophy caused by inactivity, facilitate muscle reeducation, maintain or improve the range of motion in the joints and promote local blood circulation.
The MyGait® Stimulation System is a battery-operated two-channel stimulator and was developed exclusively for everyday use during walking in an everyday environment.
The patient wears a wireless heel switch in a special sock. If the user is not able to put sufficient weight on the affected leg, he or she can wear the heel switch on the other foot. The heel switch registers heel lift and ground contact and thus the swing and stance phase. It transmits the information to the stimulator wirelessly.
The stimulator is located in a cuff that holds the electrodes. It is easy to put on, even with only one hand. The correct placement of the electrodes is achieved by the cuff. The stimulator delivers the electrical stimulation to the common peroneal nerve. The nerve stimulates for controlled dorsiflexion of the foot during the swing phase.
The second channel can be used independently of the first channel to provide stimulation to the knee flexors or knee extensors in patients with thigh muscle weakness.
Using the wireless remote control, the patient can control and adjust the stimulator settings. When the patient sits for an extended period, the sleep mode helps save energy.
The adjustment tool enables qualified personnel to adjust the stimulation parameters to the patient's individual needs. Stimulation parameters are used to affect movements in the foot. Examples of stimulation parameters are current, pulse width and shape, frequency, stimulation timing,
The "MyGait Soft" PC software is used to manage and analyze gait analysis data and stimulation parameters. The data is loaded from the stimulator to the adjustment tool. The stimulation parameters can be restored to the stimulator from the PC.
The Otto Bock Healthcare Products GmbH MyGait Stimulation System, referenced in K141812, did not report a clinical study on human subjects to determine device performance against acceptance criteria. Instead, substantial equivalence was established by comparing the technical characteristics and indications for use of the MyGait Stimulation System to three legally marketed predicate devices: WalkAide (K123972), Empi 300pv (K021100), and NESS L300 Plus System (K103343). The document primarily focuses on demonstrating that the new device's specifications fall within the range or are similar to those of the predicate devices, and that it complies with relevant electrical safety and electromagnetic compatibility standards.
Therefore, the following information cannot be fully provided as a traditional performance study was not conducted or reported in this 510(k) summary:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- Multi reader multi case (MRMC) comparative effectiveness study findings
- Standalone (i.e. algorithm only without human-in-the loop performance) findings
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
However, based on the provided document, here's a summary of the technical specifications and how they align with the substantial equivalence claim:
1. Table of Acceptance Criteria and the Reported Device Performance
Since this is a 510(k) for substantial equivalence based on technical comparison, there isn't a direct "acceptance criteria" table from a performance study. Instead, the "acceptance criteria" are implied by the ranges and characteristics of the predicate devices. The "reported device performance" are the MyGait's technical specifications.
| Feature / Criterion (Implied by Predicate Devices) | MyGait Stimulation System Reported Performance |
|---|---|
| Indications for Use | Ankle dorsiflexion or extension; thigh muscle weakness; upper motor neuron injury/disease; improve gait; prevent/retard atrophy; facilitate muscle reeducation; maintain/improve range of motion; promote local blood circulation. |
| Power Source | Built-in Lilon battery (3.7V, 1100mAh) |
| Patient Leakage Current (normal condition) |
§ 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).