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The L100 Go System is intended to provide ankle dorsiflexion in adults with foot drop or muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to the spinal cord). The L100 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot; thus, it also may improve the adult's gait.

The L100 Go System may also:

• · Facilitate muscle re-education
• · Prevent/retard disuse atrophy
• · Maintain or increase joint range of motion
• · Increase local blood flow

The L100 Go System is designed to improve gait in adults suffering from foot drop or muscle weakness. The L100 Go System can also deliver transcutaneous stimulation to the muscles in the lower leg to facilitate muscle re-education, prevent/retard disuse atrophy, maintain or increase joint range of motion, and/or increase local blood flow.

The L100 Go system consists of the following L300 Go components/accessories with the exception of a modified lower leg cuff:

• 1. External Pulse Generator (EPG), which can be plugged into Lower Leg Cuff. EPG contains user interface including control and indications. EPG also contains integrated motion sensors enabling detecting gait events.
• 2. Lower Leg Cuff, including cradle for the EPG. This is the only L300 Go component modified for the L100 Go.
• 3. Clinician Application (CAPP), installed on tablet PC. CAPP is used by a trained clinician during configuration of the system for optimal fitting to the patient.
• 4. Power supply (charger) with two USB ports and a proprietary cable to charge the EPG.
• 5. Tester, which is used for trouble shooting to confirm that stimulation is being delivered.
• 6. Optional Mobile Application (MAPP), based on the iOS and Android SmartPhone platform enabling the patients to wirelessly control the EPG(s) and retrieve and monitor their daily activity.
• 7. Electrode and electrode bases which are attached to the inner side of the lower leg cuff.

The L100 Go System can be operated in one of the following modes:

• Gait Mode
• Training Mode •
• . Clinician Mode

Gait Mode is used for walking, and it can be selected by the clinician and also by the patient. Training Mode is used to train muscles when patients are not walking (for example, sitting or lying down), and it can be selected by either the clinician or the patient. Clinician Mode allows the clinician to apply enhanced training and is only available to the clinicians.

This document is a 510(k) Pre-market Notification for a modified medical device, the L100 Go System. The submission claims substantial equivalence to a legally marketed predicate device, the L300 Go System.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes modifications to a pre-existing medical device, the L300 Go System, resulting in the L100 Go System. The acceptance criteria are implicit in the claim of "substantial equivalence" to the predicate device and the successful completion of "verification testing" for the modified components. Since this is a Special 510(k) for device modifications, specific performance metrics are not explicitly presented as acceptance criteria and reported performance in a table format. Instead, the document focuses on demonstrating that the changes do not negatively impact the safety and effectiveness, and that the modified components meet their design specifications.

The provided text states:

• "The modified cuff design was subjected to verification testing to ensure no loss of mechanical strength and functionality."
• "The L100 Go System has been verified and validated successfully for its intended use through the combination of predicate device bench testing and thorough verification and validation testing of all changes."
• "Based on the result of the nonclinical testing, Bioness concludes that the device is substantially equivalent to the predicate L300 Go System."

This indicates that the acceptance criteria were that the modified cuff design would show no loss of mechanical strength and functionality compared to the predicate device, and that all changes would pass verification and validation testing to confirm safety and effectiveness for its intended use.

The reported device performance is that these tests were "successfully" completed, affirming that the L100 Go System maintains substantial equivalence to the L300 Go System despite the modifications.

2. Sample size used for the test set and the data provenance:

The document describes "nonclinical tests" and "verification and validation testing of all changes." However, it does not specify the sample size used for these tests. The data provenance is also not explicitly stated beyond being "nonclinical testing" performed by the manufacturer (Bioness Inc.). It is implied to be laboratory/bench testing rather than clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. As the testing focuses on mechanical strength and functionality of hardware modifications, the "ground truth" would likely be established by engineering and quality control experts within Bioness, following established testing protocols, rather than medical experts for clinical performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided. As it's nonclinical verification testing, formal adjudication methods by external experts, as seen in clinical studies, are typically not applicable. The results would be assessed against pre-defined engineering and performance 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:

This is not applicable. The device (L100 Go System) is an external functional neuromuscular stimulator for foot drop, not an AI-powered diagnostic or assistive technology for human "readers." Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers would not be relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable. The L100 Go System is a physical medical device (an external functional neuromuscular stimulator), not an algorithm or software-only device. Its performance inherently involves the device interacting with a patient's body under clinician or patient control.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the "nonclinical tests" related to the modified cuff design, the ground truth would be based on engineering specifications and established performance standards for mechanical strength and functionality. This would involve objective measurements (e.g., tensile strength, durability, electrical output parameters) compared against pre-defined thresholds derived from the predicate device and relevant industry standards (e.g., IEC 60601 series).

8. The sample size for the training set:

This is not applicable. The L100 Go System is a modified physical medical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

This is not applicable, as there is no training set for this type of device.

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