Ahead 100 EEG test missed its goals but helped rule out injury on CT

In FDA's review of the BrainScope Ahead 100, the EEG test missed its accuracy endpoints in 552 patients with head injury. Its negative predictive value for injury on CT was 89.5%.

  • Not rated an organization

    Physicians did not see the device output, so no CT scan was avoided in the study. FDA's figure of 29% rests on assumptions.

Depth runs from 1, a convenience or time saved, to 5, a life or a livelihood preserved.

Status
Reported and intended benefits.
Evidence

foundstudiedreportedclaimed

An independent regulatory document supports the benefit.

Compared with

Pre-specified endpoints for the lower confidence limits of sensitivity and specificity. Measured.

Without the system
Lower limits above 78% for sensitivity and 50% for specificity
With it
Sensitivity 78.5% and specificity 48.6%, with the endpoints missed
The system’s part
Not isolated. Physicians did not see the output, and the study compared it with CT findings. It did not compare decisions with and without the device. FDA reviewers describe a classification algorithm with a discriminant score set in an earlier study, and they do not say how it was derived from data.
Limits
Not yet checked.
Costs and harms
Not yet checked.
Later
Not yet checked.

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Benefit type
Improved Task Accuracy
System
BrainScope Ahead 100 (Models CV-100 and M-100)
Made by
BrainScope Company, Inc.
Used by
BrainScope (B-AHEAD II study at 11 US emergency department sites)
Where
Eleven emergency department sites, United States
Stage
In a pilot
Date
, when the source was published
Kind
Aggregate result
Broad benefit
Identifying Objects, Actions, and Events
Collections
Scrutiny and findings
Last revised
31 October 2026

Sources

  1. Regulatory document, by authors with no tie to the system.

    U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo Classification Request for BrainScope Ahead 100, Models CV-100 and M-100 (DEN140025): decision summary. Granted 2014-11-17.

    While the clinical study failed to meet the predefined primary endpoints, the use of the Ahead 100 device may provide adjunctive information about patients when the clinician does not deem it necessary to order a CT scan, adding confidence in the clinical decision path.

Details

AI system

Workflow

Staff recorded EEG from frontal electrodes in the emergency department within 24 hours of the injury. The classification algorithm was fixed before the validation study.

Follow-up

Conditions for replication

The patient is 18 to 80 years old with a closed head injury and a Glasgow Coma Scale score of 13 to 15. Clinicians use the result with standard assessment and never as a substitute for a CT scan.

Entry details

Sector

Healthcare.

Purpose

BrainScope built the Ahead 100 to help clinicians evaluate adults with mild head injury who are being considered for a head CT.

Not yet checked: model, release, provider, role, configuration, inputs and outputs, autonomy, human oversight, AI contribution, beneficiaries, reach, distribution and access, duration, every measurement question, every money question, ownership and control, dependencies, cross-border connections, geopolitical implications, replication attempts, availability, institutional decision, grounds, action and result, success criterion, every evidence question, observed or intended, alternative assessments, related entries, other identifiers, category mappings.

Cite this record

Peter H. Vartanian. (2026). Ahead 100 EEG test missed its goals but helped rule out injury on CT (AIBD-0786). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0786.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)

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