(98 days)
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:
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- 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.
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- Lower leg FSC, including cradle for the EPG.
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- Upper leg FSC, including cradle for the EPG.
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- 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.
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- Power supply (charger) with two USB ports and a proprietary cable to charge the EPG.
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- L300 Go Tester.
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- Optional Control Unit that allows simple control of the EPG(s).
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- Optional Foot Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
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- 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.
| Test Type | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Environmental Ingress Protection (CU) | Successfully passed the testing | The modified CU successfully passed the Environmental Ingress Protection testing. |
| Mechanical Vibration and Shock (EPG) | Successfully passed the testing | The modified EPG successfully passed the Mechanical Vibration and Shock testing. |
| Packaging and Shipping Tests (ASTM D5276-98, Schedule A, Level III) | All tests passed | All packaging passed all tests. |
| Software Verification Testing (MAPP) | No loss of original functionality | Software changes were subjected to verification testing to include regression testing to ensure no loss of original functionality. |
| Software Validation Testing (New MAPP Functions) | New functions perform as intended | New functions were subjected to both verification testing (including regression testing) and validation testing. |
| Electrical Safety and Electromagnetic Compatibility | Maintained compliance from predicate | Evaluated for applicability to the design modifications. (Implies continued compliance based on predicate) |
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.
§ 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).