Ahead 300
BRAINSCOPE COMPANY INCThe Ahead 300 is a portable, non-invasive medical device that records and analyzes brain electrical activity to assist clinicians in evaluating patients with closed head injuries. It provides algorithm-based classifications of structural brain injury and measures brain function and cognitive performance to support diagnosis and treatment decisions, particularly to aid in deciding on the necessity of head CT scans.
Intended Use
The Ahead 300 is indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients being considered for head CT who sustained a closed head injury within 72 hours, present with GCS 13-15, ages 18-85 years. It records, measures, analyzes, and displays brain electrical activity using quantitative EEG parameters from frontal locations on the forehead, to provide structural injury classification and cognitive assessments. It is not a substitute for CT.
Technology
The Ahead 300 uses a portable mobile device platform with a single-use Ag/AgCl electrode array headset to acquire EEG data at 1 kHz sampling rate, downsampled to 100 Hz for algorithm processing. It computes standard quantitative EEG measures including Absolute/Relative Power, Asymmetry, Coherence, Fractal Dimension. It provides a three-tier structural injury classification (Negative, Equivocal, Positive) and cognitive performance tests. The device evolved from the Ahead 200, incorporating additional functions from predicate devices ANAM Test System (cognitive testing) and Neurometric Analysis System (brain function index).
Performance
Bench testing of software, hardware, and systems confirms safety and performance compliance to IEC and FDA standards. Clinical validation with 720 adults demonstrated the device's improved accuracy over the Ahead 200 in distinguishing patients with structural brain injury visible on CT vs. no injury, achieving high sensitivity, specificity, and reproducibility. Secondary endpoints for brain function index and cognitive assessments were also met, validating the technology's clinical utility.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/15/2016
5 months - 2
FDA Approval
9/22/2016
Other devices from BRAINSCOPE COMPANY INC
- BrainScope TBI2019 • 510K
- Brainscope Ahead 2002015 • 510K
- BrainScope Ahead 1002014 • DE NOVO
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