Ahead 300

K161068

BRAINSCOPE COMPANY INC · cleared 2016-09-22 · product code PIW · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The Ahead 300 is a portable, non-invasive, non-radiation emitting, point of care device intended to provide results and measures to support clinical assessments and aid in the diagnosis of traumatic brain injury (TBI).”
AlgorithmAlgorithm-based structural injury classification of head injured patients using EEG features, with a three-tier classification (Negative, Equivocal, Positive outputs). Also uses multivariate composite features for brain function index.
source quote (p.5)
“Both devices provide an algorithm-based structural injury classification of head injured patients using EEG features.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=720 patients

endpoints: sensitivity; specificity; negative predictive value (NPV); repeatability; reproducibility; quantitative information about brain function using the EEG Brain Function Index; scales with severity of functional impairment; reducing the risk of false negatives through the addition of the Equivocal Zone for classification of structural TBI

standards: IEC 60601-1/A1:2012, IEC 60601-1-2/A1;2007, IEC 60601-1-6/A1:2013, IEC 60601-2-26:2012, ANSI/AAMI EC12:2000/(R)2010, ANSI/AAMI/ISO 10993-1:2009, ANSI/AAMI/ISO 10993-5:2009, ANSI/AAMI/ISO 10993-10:2010, MIL-STD-810G, IEC 60529 (2004), ASTM D4169 - 09

Reported performance (1 observation)

npvas written: “negative predictive value (NPV)”stated without value
source quote (p.14)
“A high negative predictive value (NPV), and repeatability and reproducibility of the device result were also successfully demonstrated.”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Neurology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K161068