BrainScope TBI
BrainScope Company, Inc.BrainScope TBI is a portable, non-invasive device that assists clinicians in evaluating patients with mild traumatic brain injury and concussion by analyzing brain electrical activity through EEG along with cognitive tests and clinical symptoms. It helps identify the likelihood of structural brain injury and assesses brain function, supporting decisions about the need for further imaging like CT scans.
Intended Use
Adjunct to standard clinical practice to aid in the evaluation of patients with closed head injury, concussion/mild traumatic brain injury (mTBI), and Glasgow Coma Scale score 13-15. Provides measures for concussion evaluation, likelihood of structural brain injury seen on head CT, and brain function index.
Technology
The device analyzes frontal EEG signals using quantitative EEG parameters (Absolute/Relative Power, Asymmetry, Coherence, Fractal Dimension) combined with neurocognitive tests and clinical symptom data using multivariate classification algorithms to compute indices such as the Concussion Index (CI), Structural Injury Classification (SIC), and Brain Function Index (BFI). It is a portable, point of care device using a head sensor array and Android-based platform.
Performance
Clinical validation study conducted on 580 subjects aged 13-25 years showed the Concussion Index had a sensitivity of 85.99% and specificity of 70.78% for concussion evaluation. The device conforms to safety and EMC standards and maintains equivalence with the predicate device. Additional analyses showed strong correlation between Concussion Index and symptom inventories.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/29/2019
5 months - 2
FDA Approval
9/11/2019
Other devices from BrainScope Company, Inc.
- Ahead 3002016 • 510K
- Brainscope Ahead 2002015 • 510K
- BrainScope Ahead 1002014 • DE NOVO
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