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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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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 flexion or extension: thus, it also may improve the individual's gait.

The L300 Go System may also:

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

The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, spinal cord injury) or other disability. 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).
• 8. Optional Foot Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
• 9. Optional Mobile Application (MAPP), based on the SmartPhone platform enabling the patients to wirelessly retrieve and monitor their daily activity. At the time of clearance of K162407, the MAPP did not include any control feature, but control features like those of the Optional Control Unit have been added to the MAPP and are part of this submission.

This document is a 510(k) summary for the Bioness L300 Go System, focusing on modifications made to a previously cleared device (K162407). It does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria in terms of clinical effectiveness. Instead, it describes non-clinical testing performed to demonstrate that the modifications to the device do not alter its substantial equivalence to the predicate device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria for clinical performance or reported device performance in terms of efficacy metrics (e.g., gait improvement percentages, dorsiflexion angles). It focuses on non-clinical testing to ensure that modifications to the device (e.g., changes in material, software updates) do not negatively impact its safety and functionality compared to the predicate device.

For the non-clinical tests mentioned, the "acceptance criteria" can be inferred as "successfully passed the testing," indicating that the device's performance post-modification remained within acceptable limits for the specific tests conducted.

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

The document describes non-clinical engineering and software testing. It does not refer to a "test set" in the context of clinical data or patient samples.

• Sample Size for non-clinical tests: Not explicitly stated as a number of units, but common for such tests to involve one or a small number of physical units for destructive or environmental testing.
• Data Provenance: The testing was conducted internally by Bioness or by Minnetronix Inc. (a Bioness development vendor), indicating it is internal, likely prospective, engineering bench testing. There is no mention of country of origin regarding clinical data.

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

This information is not applicable. The document describes non-clinical hardware and software testing, not clinical studies requiring expert ground truth for patient outcomes.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (e.g., 2+1) are typically used in clinical studies for interpreting ambiguous results or establishing ground truth from expert readings. The tests described are engineering and software tests with defined pass/fail criteria.

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

No MRMC study was conducted or is mentioned in this document. The submission focuses on demonstrating substantial equivalence for minor device modifications and software upgrades through non-clinical testing, not on clinical effectiveness studies.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This concept is less applicable to a functional neuromuscular stimulator that inherently requires human interaction and application by a clinician/user. The document describes software verification and validation, including for the Mobile Application (MAPP) which has user interaction, but not a "standalone algorithm" performance in the sense of an AI diagnostic tool.

7. Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is typically defined by engineering specifications, validated test methods, and industry standards (e.g., ASTM standards for packaging, internal design requirements for software functionality). Not pathology, outcomes data, or expert consensus in a clinical sense.

8. Sample Size for the Training Set:

This information is not applicable. The text describes verification and validation of modified hardware and software, not the development of a machine learning model that would require a "training set."

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

This information is not applicable, as there is no "training set" for a machine learning model mentioned.

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The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or 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 flexion or extension: thus, it also may improve the individual's gait.

The L300 Go System may also:

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

The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, spinal cord injury) or other disability. 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 qait.

The L300 Go System consists of:

• 1. One or two Functional Stimulation Cuffs (L300 Lower Leg and Thigh), that include surface electrodes.
• 2. External Pulse Generator (EPG) for the lower leg and EPG for thigh. Both EPG's deliver stimulation to their respective cuffs, and have user interface, including visual, audio, and tactile feedback. Lower EPG can use motion sensor based algorithm to detect heel events.
• 3. A Control Unit that allows simple wireless remote control of the EPG's while displaying real-time information regarding the system's status.
• 4. An optional Gait Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
• 5. A Clinician's Programming System with software, which is used for system programming by a trained clinician during configuration of the system for optimal fitting to the patient.
• 6. A power supply with two USB outputs and a proprietary cable to charge the EPG.

This document is a 510(k) Summary for the Bioness L300 Go System, a medical device intended to provide ankle dorsiflexion and/or assist knee flexion/extension. The primary purpose of this document is to demonstrate substantial equivalence to previously cleared predicate devices, not to present a comprehensive study proving device performance against acceptance criteria. Therefore, most of the requested information regarding study details, sample sizes, expert involvement, and ground truth establishment is not available in the provided text.

Based on the available information, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the L300 Go System in terms of performance metrics like accuracy, sensitivity, or specificity. Instead, it demonstrates an equivalence to predicate devices in various technical specifications and functional aspects. The tables (Table 1.0, Table 2a, Table 2b) primarily compare the technical output specifications and basic unit characteristics of the L300 Go System with its predicate devices.

The document asserts that the L300 Go System "does not introduce any new issues of safety or efficacy" relative to its predicate devices, implying that its performance is equivalent in these aspects.

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

Not provided. The document outlines a substantial equivalence argument rather than a dedicated performance study with a test set.

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

Not provided. There is no mention of a test set or ground truth established by experts.

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

Not provided. There is no mention of an adjudication method.

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 device is an external functional neuromuscular stimulator, not an AI-assisted diagnostic or imaging device that would typically involve human "readers" or an MRMC study.

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

This question generally applies to AI-driven diagnostic systems. The L300 Go System includes algorithms (e.g., motion sensor-based algorithm to detect heel events, dynamic gait tracking algorithm), but the device itself is a functional electrical stimulator, not an algorithm-only device. Its functionality inherently involves interaction with the human body to achieve a therapeutic effect. The document focuses on the technical specifications and equivalency to previously cleared devices.

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

Not provided. The document focuses on technical specifications and functional equivalence rather than clinical ground truth for a diagnostic outcome.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that would be "trained" in the traditional sense on a dataset. The document discusses "software" and "firmware" but not a machine learning training process.

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

Not applicable. See point 8.

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