(265 days)
The EvoWalk 1.0 System is intended to provide ankle dorsiflexion in adult 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., stoke, damage to pathways to the spinal cord). The EvoWalk 1.0 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 EvoWalk 1.0 system is a wearable non-invasive functional electrical stimulation (FES) device intended to provide ankle dorsiflexion in adult individuals with foot drop and/or to assist knee flexion in adult individuals with muscle weakness related to upper motor neuron diseaselinjury (e.g., stroke, damage to pathways in the spinal cord), thus providing treatment for foot drop. EvoWalk 1.0 can be used in a healthcare facility and home settings.
The EvoWalk 1.0 system consists of the EvoWalk device with an elastic band and built-in rechargeable lithium polymer battery, and the accessories including the EvoWalk mobile application, micro USB type charge cable with charge port, lead cables (one single channel and one dual channel), eight sets of electrodes for each channel, instructions for use (IFU), and a carrying case.
The provided text describes the EvoWalk 1.0 System, an external functional neuromuscular stimulator, and its submission for FDA 510(k) clearance. However, it does not include specific acceptance criteria and detailed study results to demonstrate the device meets those criteria in a format that allows for a direct population of the requested table. The document primarily focuses on establishing substantial equivalence to a predicate device (Bioness L300 Go System) through a comparison of technological characteristics and a summary of nonclinical tests performed.
Therefore, I cannot directly extract and provide the exact acceptance criteria and reported device performance from the given text in a tabular format, nor can I provide information on sample sizes for test and training sets, data provenance, expert ground truth establishment, or clinical study details as requested. The document explicitly states "Summary of Nonclinical Tests Submitted," indicating that only nonclinical (bench and software) tests were submitted, not clinical studies involving human performance metrics against specific acceptance criteria.
The information that can be extracted relates to the nonclinical testing performed to demonstrate safety and effectiveness and substantial equivalence.
Here's a breakdown of what is available and what is missing from the provided text according to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not present in the provided document. The document lists the general nonclinical tests performed but does not provide specific quantitative acceptance criteria or the numerical performance results of the EvoWalk 1.0 System against such criteria.
2. Sample size used for the test set and the data provenance:
- Sample size for the test set: Not specified. The document mentions "nonclinical testing" and "bench testing" but does not detail sample sizes for any specific components or tests.
- Data provenance: Not applicable as no clinical test set data is described. The tests are nonclinical (bench and software validation).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document describes nonclinical tests and software validation, which do not typically involve expert review for ground truth in the same way clinical image analysis or diagnostic AI studies would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This relates to clinical studies involving human observers, which are not detailed in this document.
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:
- No, an MRMC comparative effectiveness study was not done according to the provided text. The document focuses on the device's technical performance and substantial equivalence to a predicate, not how human readers improve with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly, for specific functionalities. The document mentions "Motion analysis to validate the gait event detection algorithm" and "Software validation according to IEC 62304." These are standalone algorithm performance evaluations without human-in-the-loop. However, specific performance metrics are not provided. The device itself is a functional electrical stimulator, and its core function is to deliver stimulation based on algorithms detecting gait events.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the nonclinical tests, the ground truth would be based on engineering specifications, established standards (e.g., IEC 60601 series for electrical safety, EMC, and neuromuscular stimulators), and internal verification protocols. For the "gait event detection algorithm," the ground truth would likely be established through sensor data from controlled movements where gait events are precisely known or measured independently. No specific external expert consensus, pathology, or outcomes data are mentioned for ground truth.
8. The sample size for the training set:
- Not specified. The document does not discuss a training set for the device's algorithms, implying that the algorithm might be rule-based or trained using internal data without explicit mention of size.
9. How the ground truth for the training set was established:
- Not specified, as no training set is explicitly discussed.
Summary of Nonclinical Tests Mentioned:
The document primarily relies on nonclinical testing to support the safety and effectiveness and substantial equivalence of the EvoWalk 1.0 System. The tests performed include:
- Technological Characteristics of Powered Muscle Stimulation Stimulation Output Waveforms
- Motion analysis to validate the gait event detection algorithm
- Electrical Safety according to IEC 60601-1; IEC 60601-1-11
- Muscle and Nerve Stimulators according to IEC 60601-2-10
- Electromagnetic compatibility according to IEC 60601-1-2
- Software validation according to IEC 62304
The document concludes that "Evolution Devices believes the EvoWalk 1.0 system is substantially equivalent to the Bioness L300 GO system (K173682), and does not raise any new issues or concerns of safety or effectiveness. The evidence presented in the bench testing and non-clinical testing is sufficient to support the safety and effectiveness of the device."
In essence, the provided text details the regulatory context (510(k) summary) and the types of nonclinical tests conducted to support substantial equivalence, but it does not contain the detailed quantitative results and specific acceptance criteria that would be found in a full clinical study report or a detailed test report.
§ 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).