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The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g. stroke, damage to pathways to the spinal cord). The L300 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension: thus, it also may improve the individual's gait.

The L300 Go System may also:

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

The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L300 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait.

The L300 Go system consists of the following components:

• 1. External Pulse Generator (EPG), which can be plugged into lower leg Functional Stimulation Cuff (FSC) or thigh FSC or into both cuffs. EPG contain user interface including control and indications. EPG also contains integrated motion sensors enabling detecting gait events.
• 2. Lower leg FSC, including cradle for the EPG.
• 3. Upper leg FSC, including cradle for the EPG.
• 4. Clinician Application (CAPP), based on tablet PC. CAPP will be used by a trained clinician during configuration of the system for optimal fitting to the patient.
• 5. Power supply (charger) with two USB ports and a proprietary cable to charge the EPG.
• 6. L300 Go Tester.
• 7. Optional Control Unit that allows simple control of the EPG(s) such as selecting mode of operation (gait/training) or fine-tune the stimulation intensity for each EPG individually.
• 8. Optional Foot Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
• 9. Optional Mobile Application (MAPP), which can be downloaded on a smartphone and offers the same control functions as the optional Control Unit, as well as enabling the patients to retrieve and monitor their daily activity. At the time of clearance of K173682, the MAPP was only an iOS-based application. In this submission, Bioness is adding an Android-based MAPP. The software features, user interface, and wireless communication protocol of the Android version are the same as the iOS version, the only difference is the operating system.

The L300 Go System can be operated in one of the following modes:

• Gait Mode
• Training Mode ●
• . Cycle 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. Cycle Training Mode is used to train muscles while the patient is using a stationary exercise bicycle, 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.

The provided text describes a Special 510(k) submission for the Bioness L300 Go System, primarily focused on device modifications including software changes and the addition of an Android version Mobile Application. The submission asserts that these changes do not affect the intended use or fundamental scientific technology of the device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria in a quantitative table for this specific Special 510(k) submission. Instead, the submission focuses on demonstrating that the modified device maintains the safety and efficacy previously established for its predicate device (K173682) through verification and validation testing of the changes.

The reported device performance, in this context, refers to the successful completion of these tests:

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify sample sizes used for the "verification testing" or "validation testing" mentioned for software/firmware/cyclic training mode. It also does not provide information on the provenance of data (e.g., country of origin, retrospective/prospective). These details would typically be found in more comprehensive study reports, which are not included in this FDA 510(k) summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This document does not describe any study involving human experts establishing ground truth for a test set. The testing described appears to be engineering or performance testing against predefined technical specifications and standards.

4. Adjudication Method for the Test Set

Not applicable, as there's no mention of a ground truth established by human experts or a test set requiring adjudication in the context of this document. The testing described is primarily technical verification and validation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned in this document. The device is a functional neuromuscular stimulator, not an imaging or diagnostic AI tool that would typically involve human readers interpreting cases.

6. Standalone (Algorithm Only) Performance Study

While the document describes rigorous testing of the device's software and hardware (including the algorithms within the EPG and mobile applications), it doesn't present this as a "standalone" performance study in the context of a comparative effectiveness study against a human baseline or a widely accepted clinical standard for an AI diagnostic algorithm. The aim here is to confirm the device's functional integrity after modifications.

7. Type of Ground Truth Used

The "ground truth" for the tests described appears to be:

• Technical Specifications and Requirements: For software/firmware functionality and the cyclic training mode.
• Industry Standards: For environmental ingress protection (IP42) and transportation testing.
• Predicate Device Performance: The primary "ground truth" is that the modified device should perform equally safely and effectively as the previously cleared predicate device (K173682).

8. Sample Size for the Training Set

The document does not describe any "training set" in the context of machine learning or AI models being trained. The "software and firmware changes" likely refer to updates in control logic, user interface, or functional modes, which are verified and validated rather than trained on data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for an AI model is mentioned or implied.

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