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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.

2. Sample size used for the test set and the data provenance
No clinical test set of human subjects was reported for performance evaluation against acceptance criteria. The evaluation was based on a comparison of technical specifications to predicate devices and compliance with international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no human subject test set requiring ground truth establishment by experts was reported.

4. Adjudication method for the test set
Not applicable.

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. This is a functional electrical stimulator, not an AI-assisted diagnostic or imaging device for which MRMC studies would typically be conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical stimulator used on a patient. Its functionality involves direct interaction with the human body and is not an "algorithm only" device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The ground truth for this submission is based on engineering specifications and compliance with recognized international safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10, IEC 60601-1-2).

8. The sample size for the training set
Not applicable, as this is not a machine learning/AI device requiring a training set in that context. The device's operation is based on established electrical stimulation principles, not learned from data.

9. How the ground truth for the training set was established
Not applicable.

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