(168 days)
The Felix™ NeuroAI™ Wristband is indicated to aid in tremor-related functional limitations in the upper limbs in adults with essential tremor.
Fasikl's Felix™ NeuroAI™ Wristband is a wrist-worn, noninvasive, transcutaneous neurostimulation system. It is intended to be used by adult patients with essential tremor (ET) on a daily basis to aid in tremor-related functional limitations in the upper limbs. The system continuously monitors tremor frequency and tremor amplitude and automatically adjusts stimulation settings. The Felix system consists of the following components: Felix wristband (NeuroAI™ stimulator with integrated strap and detachable connector band), disposable electrode band, wireless charger, and smartphone application.
The Felix NeuroAI System is an external upper limb tremor stimulator cleared via a 510(k) pathway. The device's acceptance criteria are based on a superiority study (TRANQUIL study) against a sham control, demonstrating its effectiveness in aiding tremor-related functional limitations.
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criterion for the Felix NeuroAI System was demonstrating superiority over sham stimulation in the primary effectiveness endpoint.
| Acceptance Criterion (Primary Endpoint) | Reported Device Performance (Felix Group) |
|---|---|
| Superiority of Felix versus Sham stimulation in Change in TETRAS modified Activities of Daily Living (mADL) score from baseline pre-stimulation to Day 90. | Change in TETRAS mADL score (Felix vs. Sham): |
- Prespecified Primary Analysis (excluding missing data):
- Felix: -6.9 ± 5.96 (mean ± SD)
- Sham: -2.7 ± 4.12 (mean ± SD)
- Difference of average paired difference: -4.2
- 95% CI: [-6.2, -2.2]
- p-value: **
§ 882.5897 External upper limb tremor stimulator.
(a)
Identification. An external upper limb tremor stimulator is a prescription device which is placed externally on the upper limb and designed to aid in tremor symptom relief of the upper limb.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must assess the following:
(i) Characterization of the electrical stimulation, including the following, must be performed: Waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.
(ii) Impedance testing, current distribution across the electrode surface area, adhesive integrity, and shelf life testing of the electrodes and gels must be conducted.
(iii) Simulated use testing of sensor performance and the associated algorithms that determine the stimulation output must be conducted.
(2) Patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Physician and patient labeling must include:
(i) Summaries of electrical stimulation parameters;
(ii) Instructions on how to correctly use and maintain the device;
(iii) Instructions and explanations of all user-interface components;
(iv) Instructions on how to clean the device;
(v) A shelf life for the electrodes and gel; and
(vi) Reuse information.