(27 days)
The Innovative Neurotronics WalkAide System is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of gait, the WalkAide electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the patient's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.
The WalkAide is an external functional electrical stimulator. It is a small device that attaches to the leg just below the knee, near the head of the fibula. During a gait cycle, the WalkAide stimulates the common peroneal nerve, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle. The WalkAide System consists of the WalkAide Patient Kit and the WalkAide Clinician Kit . The WalkAide Patient Kit comprises of all the components and accessories that the patient will take home and use. The Clinician System comprises the accessories that a clinician (i.e., orthotic specialist, physiotherapist, occupational therapist, etc.) will use to set up a patient's WalkAide.
The provided 510(k) summary for the Innovative Neurotronics, Inc. WalkAide System does not contain the detailed information requested regarding specific acceptance criteria, a study proving performance against those criteria, or the ground truth establishment process.
The document states that "Applicable performance and safety testing was performed to verify technological and functional characteristics including any design modification," and that "Any design modifications do not raise any safety or effectiveness issues." However, it does not elaborate on what these performance and safety tests entailed, the acceptance criteria used, or the results of such tests.
Therefore, I cannot populate the table or answer most of the specific questions. Based on the provided text, here is what can be inferred or explicitly stated:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "substantially equivalent to the parent Walk-Aide" |
| Not specified | "Applicable performance and safety testing was performed to verify technological and functional characteristics" |
Here are the answers to the specific questions, based on the provided text:
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A table of acceptance criteria and the reported device performance
- As shown in the table above, the document does not specify quantitative acceptance criteria or detailed reported device performance. It only states that the device is "substantially equivalent" to predicate devices and that "applicable performance and safety testing was performed."
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- This information is not provided in the 510(k) summary.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- This information is not provided in the 510(k) summary.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not provided in the 510(k) summary.
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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
- This is not applicable as the WalkAide is an FES device, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable in the context of an FES device. The device itself is the "algorithm" delivering stimulation, but the performance is measured on the patient's gait, not against a diagnostic benchmark. The document does not describe standalone performance testing beyond the general statement of "technological and functional characteristics."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The document does not specify the type of ground truth. Given the nature of an FES device, "ground truth" would likely relate to objective measures of gait improvement or physiological effects, but this is not detailed.
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The sample size for the training set
- This information is not provided in the 510(k) summary. The WalkAide is a medical device, not a machine learning algorithm that typically requires a "training set" in the computational sense. The "training" for such a device would refer to clinical use and patient adaptation.
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How the ground truth for the training set was established
- This information is not provided. As noted above, the concept of a "training set" and "ground truth for training" in the machine learning context does not directly apply here without further explanation within the document.
§ 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).