(274 days)
The Neurolutions IpsiHand Upper Extremity Rehabilitation System is indicated for use in chronic stroke patients (≥ 6 months post-stroke) age 18 or older undergoing stroke rehabilitation, to facilitate muscle re-education and for maintaining or increasing range of motion in the upper extremity.
The Neurolutions IpsiHand Upper Extremity Rehabilitation System (a.k.a. Neurolutions System or IpsiHand System) detects goal-oriented brain activity using non-invasive EEG electrodes to allow a stroke patient to perform therapeutic exercises that they would otherwise not be able to perform, due to their impairment. The Neurolutions System consists of the Neurolutions Handpiece, a Tablet computer, and a Biometric Headset. Using a standard Windows Tablet as the patient interface, the System translates brain signals from the Biometric Headset into movement of the motor-driven Handpiece worn over the patient's hand and wrist. The motion of the Handpiece, in turn, opens and closes the patient's impaired hand. The combined action of these System components allows the stroke patient to perform physical therapy exercises that they would otherwise not be able to perform, due to their impairment. The Biometric Headset, which contains dry electroencephalographic (EEG) sensors, receives electrical signals from the motor or pre-motor cortex, predominantly of the unaffected hemisphere of the patient's brain, and in doing so, detects the patient's intentions to move their affected hand. These intentions to move are translated into motor movements of the Handpiece using software that drives a linear actuator contained inside of the Handpiece. The Handpiece opens and closes the hand using a 3-finger pincer grip mechanism designed to emulate the movement of grasping an object using the two forefingers and thumb in a grasping motion (one degree of freedom). The device functions as powered exercise equipment for the patient's hand using three separate modes: the main mode of therapy is referred to as the brain-computer interface (BCI) or 'thought' mode in which the patient's hand is opened or closed by the powered orthosis based on brain signals received from the Biometric headset; the second mode is referred to as a 'volitional' mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient's hand passively through a comfortable range of motion in a repetitive fashion. The Neurolutions System is designed for use in clinic or home settings as part of prescribed rehabilitation therapy.
Acceptance Criteria and Device Performance for Neurolutions IpsiHand Upper Extremity Rehabilitation System
The Neurolutions IpsiHand Upper Extremity Rehabilitation System is an EEG-driven upper extremity powered exerciser indicated for use in chronic stroke rehabilitation. The device's safety and effectiveness were evaluated through a series of clinical investigations and non-clinical studies.
1. Table of Acceptance Criteria and Reported Device Performance
The regulatory information outlines several special controls which act as acceptance criteria. The summaries of non-clinical and clinical studies demonstrate how these criteria were met.
| Acceptance Criteria (Special Controls) | Reported Device Performance and Study Findings |
|---|---|
| (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must capture any adverse events observed during clinical use and must demonstrate that the EEG signal can be translated into intended motion. | Studies QRS-0008, ORS-0012, and ORS-0013 (preliminary) all evaluated clinical performance: * QRS-0008: Demonstrated statistically significant improvement in ARAT (mean 6.6 points, 6/10 subjects exceeded MCID). Secondary outcomes (COPM, Motricity Index, grip strength) also significantly improved. Minor fatigue reported in 1 subject; no patient injury or adverse events. * ORS-0012: From baseline to 12 weeks, patients (n=17) demonstrated a mean improvement of (b) (9) in UEFM with a SD of (b) (4) (p |
§ 890.5420 Electroencephalography (EEG)-driven upper extremity powered exerciser.
(a)
Identification. An EEG-driven upper extremity powered exerciser is a non-invasive prescription device intended for rehabilitation by driving movement or exercise of an impaired upper extremity in response to the detection of purpose oriented electrical activity produced by the patient's brain.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must capture any adverse events observed during clinical use and must demonstrate that the EEG signal can be translated into intended motion.
(2) Software verification, validation, and hazard analysis must be performed.
(3) Performance data must demonstrate the electromagnetic compatibility, electrical safety, battery safety, and wireless compatibility of the device.
(4) The device components that contact the patient must be demonstrated to be biocompatible.
(5) Performance data must validate the reprocessing instructions for the reusable components of the device.
(6) Labeling must include:
(i) Instructions on fitting the device to the patient;
(ii) Information on how the device operates and the typical sensations experienced during treatment; and
(iii) Reprocessing instructions.