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510(k) Data Aggregation
(96 days)
The Innovative Neurotronics WalkAide External Functional Neuromuscular Stimulator (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 System 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 text describes a 510(k) summary for the Innovative Neurotronics, Inc. WalkAide System, which is an external functional neuromuscular stimulator. The summary focuses on demonstrating substantial equivalence to predicate devices, particularly regarding changes in output specifications (voltage, pulse width, and addition of ramp modulation).
Here's an analysis of the acceptance criteria and the "study" (which in this context refers to the technical comparison and testing described for regulatory approval):
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantifiable manner as "acceptance criteria" for a study in the typical sense of clinical trials. Instead, the document frames "acceptance" as meeting applicable safety and performance standards (like IEC 60601-2-10) and being substantially equivalent to predicate devices. The "reported device performance" refers to the technical specifications and measured values of the proposed WalkAide (K123972) and a comparison to its predicate (K052329) and other competitive devices (Bioness L300 Plus, Odstock Pace).
Below is a table summarizing key electrical output criteria and the proposed device's performance, as derived from the "Predicate Comparison Table" and the "Discussion of Table 6.1 equivalent parameters" section.
| Feature | Acceptance Criteria (typically derived from standards or predicate equivalence) | Proposed WalkAide (K123972) Performance (Measured/Computed) | Comparison/Comments |
|---|---|---|---|
| Output Stage Type | Must be suitable for functional electrical stimulation, comparable to predicates (Constant Voltage or Constant Current). | Constant Voltage (Adjustable) | Identical to previous WalkAide. Predicates Bioness & Odstock are Constant Current. Considered equivalent in functionality. |
| Output Voltage Range | Safe and effective range, within the scope of predicate devices (e.g., similar to Bioness 120V or Odstock's 100±10%V @ 1000 Ohms). | 0 - 110V (±10%) at 1000 Ohms load | Within range of Bioness (120V) and Odstock Pace (100±10%V). |
| Max Output Current (500Ω) | Should not exceed limits defined by applicable standards (e.g., IEC 60601-2-10 paragraph 51.104 for rms current, and general safety). Comparable to predicate devices. | <206.8 mA peak (specification limit); 14.2 mA rms max (measured) | Measured rms current (14.2 mA) is in the same range as Bioness (13.1 mA rms) and less than Odstock (20.6 mA rms). Meets the 50 mA rms limit of IEC 60601-2-10 (paragraph 51.104). |
| Max Output Voltage (1000Ω) | Safe output voltage, comparable to predicates (e.g., Bioness 120Vpk, Odstock 108Vpk). | 121 V max (specification limit); <121 V peak (specification limit) | Proposed 121V is within <1% of Bioness (120Vpk). Meets IEC 60601-2-10 specification limit of 500V peak. With 1M Ohm load, proposed is <150V (measured 123V), comparable to Odstock (measured 150V). |
| Ramp Modulation | Presence of ON/OFF ramp features comparable to competitive devices. | Yes (ON Ramp 0-0.5s, OFF Ramp 0-0.5s in 0.1s steps) | Added feature, shown to be equivalent to ramping in Bioness L300 Plus (0-2s) and Odstock Pace (0-2s). |
| Pulse Duration | Safe and effective range, comparable to predicate devices (e.g., Bioness 100-300 µs, Odstock 0-360 µs). | 25-300 microseconds (±5% or ±7 µs); adjustable in discrete steps: 25, 50, 100, 150, 200, 250, and 300 µs. | Proposed max (300 µs) is equal to Bioness and less than Odstock (360 µs). Proposed min (25 µs) is within Odstock range (0-360 µs). Considered equivalent. |
| Frequency Range | Safe and effective range, comparable to predicate devices. | 16.7, 20.0, 25.0, and 33.3 pulses per second (Hz) | Identical to parent device. Considered essentially equivalent to Bioness (20-45 pps) and Odstock (20-60 pps). |
| Max Phase Charge (500Ω) | Must be below published safety limits (e.g., 75 µC for ANSI/AAMI NS4-1985). Comparable to predicate devices. | 41.2 MicroCoulombs (µC) measured | Significantly lower than the 75 µC safety limit (ANSI/AAMI NS4-1985). Equivalent to Odstock (41 µC). |
| Max RMS Current Density | Must be within safety limits derived from applicable standards (e.g., 6.32 mA rms/cm² from IEC 60601-2-10 50 mA rms limit, or 7.95 mA rms/cm² from FDA guidance 0.25 W/cm² limit). | 1.80 mA rms/cm² measured | Below derived safety limits (6.32 mA rms/cm² from IEC 60601-2-10; 7.95 mA rms/cm² from FDA guidance). Higher than Odstock/Bioness (0.82 mA rms/cm²), but still deemed safe. |
| Max Average Power Density | Must be below safety limits (e.g., 0.25 Watts/cm² from FDA guidance, or 0.16 Watts/cm² from IEC 60601-2-10 50 mA rms limit). Comparable to predicate devices. | 0.027 Watts/cm² max (computed assuming square pulse); 0.0128 Watts/cm² (measured using rms current levels) | Measured power density (0.0128 W/cm²) is an order of magnitude below the FDA limit (0.25 W/cm²). |
| Compliance with Standards | Compliance with relevant electrical safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, 21 CFR 898). | IEC 60601-1 3rd Ed, IEC 60601-1-2:2007, IEC 60601-2-10:1987+A1, 21 CFR 898. "V012 "WalkAide Performance Test Protocol" tests to the applicable requirements of IEC 60601-2-10." | Updated to newer editions of general standards (IEC 60601-1 3rd Ed, IEC 60601-1-2:2007), maintaining compliance with the specific medical device standard (IEC 60601-2-10). |
2. Sample Size Used for the Test Set and the Data Provenance
This document describes a premarket notification (510(k)) based on substantial equivalence, not a clinical trial with a "test set" in the traditional sense of patient data. The "test set" here refers to the extensive technical testing and benchmarking performed to assess the electrical and functional characteristics of the device against established standards and predicate device specifications.
- Sample Size for Test Set: The document does not specify a "sample size" of patients or data points for a clinical test set. The evaluation is based on technical specifications, direct measurements, and comparisons of the device's electrical output to standards and predicate devices. For example, voltage and current measurements are taken on the device itself under specified load conditions.
- Data Provenance: The data primarily comes from bench testing and technical performance evaluations of the WalkAide (K123972) and its predicate (K052329). The comparative data for Bioness L300 Plus and Odstock Pace is extracted from their respective 510(k) summaries or available specifications. This is not patient-derived data (retrospective or prospective) in the context of clinical outcomes. The document repeatedly refers to "V012 'WalkAide Performance Test Protocol'" as the method used to validate the device's adherence to applicable requirements of IEC 60601-2-10.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
In this 510(k) context, "ground truth" for the test set is established by the applicable international and national consensus standards (e.g., IEC 60601 series, ANSI/AAMI NS4-1985) and the specifications of legally marketed predicate devices.
- Number of Experts: Not applicable in the sense of a panel of clinical experts defining ground truth for patient outcomes. The "experts" are the engineers, regulatory specialists, and standards committees who developed and codified the safety and performance standards.
- Qualifications of Experts: The experts who establish these standards typically include biomedical engineers, physicians, regulatory scientists, and other specialists with deep knowledge of medical device safety and efficacy, functional electrical stimulation, and relevant biophysical principles. The document itself does not specify the qualifications of individuals involved in the actual testing or in its submission from Innovative Neurotronics, Inc., beyond identifying a "Director of Quality and Regulatory."
4. Adjudication Method for the Test Set
Not applicable in the sense of clinical adjudication. The "adjudication" is essentially the regulatory approval process by the FDA, which reviews the submitted data and arguments for substantial equivalence against its own internal expertise and guidance. The technical validation is done by demonstrating compliance with established standards and direct comparative analysis against predicate device specifications, without an external adjudication panel for the technical results.
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 MRMC study was done, nor is it applicable. This device is an external functional neuromuscular stimulator, not an imaging or diagnostic AI device that involves "human readers" or "AI assistance" in interpretation. The product directly provides therapeutic stimulation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not directly applicable as an "algorithm only" study. The device itself is designed to function largely automatically based on configurable parameters set by a clinician and using integrated sensors (tilt or foot sensor). The performance described in the document is the standalone device performance (electrical output, safety parameters) rather than an isolated algorithm. The "human-in-the-loop" aspect exists during the initial setup by a clinician and ongoing patient use, but the core performance data presented is about the device's physical output characteristics.
7. The Type of Ground Truth Used
The "ground truth" used for this submission is primarily:
- Established safety and performance standards: Such as IEC 60601-2-10, IEC 60601-1, IEC 60601-1-2, ANSI/AAMI NS4-1985, and FDA guidance documents (e.g., "Guidance Document for Powered Muscle Stimulator 510(k)s").
- Specifications and demonstrated performance of legally marketed predicate devices: The historical data and approved specifications of the parent WalkAide (K052329), Bioness L300 Plus (K103343), and Odstock Pace (K102115) form the comparative basis for "ground truth" for substantial equivalence.
This is a regulatory "ground truth" for device approval, not a clinical "ground truth" based on pathology or outcomes data.
8. The Sample Size for the Training Set
- Not applicable. This document describes a 510(k) submission for a physical medical device, not a machine learning or AI algorithm that requires a "training set" of data. No training set was used.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as no training set was used.
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