(151 days)
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:
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- One or two Functional Stimulation Cuffs (L300 Lower Leg and Thigh), that include surface electrodes.
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- 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.
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- A Control Unit that allows simple wireless remote control of the EPG's while displaying real-time information regarding the system's status.
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- An optional Gait Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
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- 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.
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- 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.
| Feature / Criteria (Derived from comparison to predicates) | L300 Go System Reported Performance |
|---|---|
| Output Waveform | Biphasic Symmetrical / Asymmetrical |
| Shape | Rectangular |
| Max Output Voltage (@500Ω) | Lower leg: 50V, Thigh: 50V |
| Max Output Current (@500Ω) | Lower leg: 100mA, Thigh: 100mA |
| Pulse Width (Biphasic Symmetrical) | 100, 150, 200, 250, 300 µs |
| Frequency | 10-45 Hz |
| Net Charge per pulse (@500Ω) | 0 µC (using inverted balanced phases) |
| Max Phase Charge (@500Ω) | Lower leg: 30 µC, Thigh: 30 µC |
| Max Current Density (@500Ω) | Varies by cuff size (e.g., Lower leg small cuff: 1.63 mA/cm² (rms)) |
| Max Power Density (@500Ω) | Varies by cuff size (e.g., Lower leg small cuff: 13.4 mW/cm²) |
| Burst Mode Functionality | Yes (heel off/contact triggered, timer/complementary event terminated) |
| ON Time (Training mode) | 4-20 sec |
| OFF Time (Training mode) | 4-20 sec |
| Compliance with Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, FCC part 15 subpart C and B1, 21 CFR 898 (Yes) |
| Wireless Communication Technology | Industry-standard Bluetooth (low energy) |
| User Interface | Expanded User Interface (via Remote Control or Stimulator) |
| Clinician Programmer | Tablet/PC-based Clinician Programmer |
| Number of Stimulation Channels | One or two (lower leg), one (thigh) |
| Tilt Sensor for Gait Trigger | Yes (similar to WalkAide) |
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.
§ 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).