BrainScope TBI

K190815

BrainScope Company, Inc. · cleared 2019-09-11 · product code PIW · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“BrainScope TBI (model: Ahead 500) 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 concussion / mild traumatic brain injury (mTBI). The BrainScope TBI includes a new multivariate classification algorithm that analyzes a patient's electroencephalogram (EEG), augmented by neurocognitive performance and selected clinical symptoms to compute a multi-modal index called the Concussion Index (CI).”
Algorithmmultivariate classification algorithm that analyzes a patient's electroencephalogram (EEG), augmented by neurocognitive performance and selected clinical symptoms to compute a multi-modal index called the Concussion Index (CI)
source quote (p.6)
“The BrainScope TBI includes a new multivariate classification algorithm that analyzes a patient's electroencephalogram (EEG), augmented by neurocognitive performance and selected clinical symptoms to compute a multi-modal index called the Concussion Index (CI).”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.13)
“BrainScope TBI (model: Ahead 500) enables secure communication with cloud based infrastructure to support data synchronization.”

Validation studies (1)

Retrospective clinical

n=580 patients · 10 site(s)

endpoints: sensitivity; specificity

standards: IEC 60601-1/A1:2012 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance, IEC 60601-1-2 Edition 4.0 2014 General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, IEC 60601-1-6/A1:2013 General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability, IEC 60601-2-26:2012 Particular requirements for the basic safety and essential performance of electroencephalographs, ANSI/AAMI EC12:2000/(R)2010 Disposable ECG Electrodes, ANSI/AAMI/ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, ANSI/AAMI/ISO 10993-5:2009 Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity, ANSI/AAMI/ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Test for irritation and skin sensitization, MIL-STD-810G, Department of Defense Test Method Standard for Environmental Engineering Considerations and Laboratory Tests, IEC 60529 (2004) Degree of Protection Provided by Enclosures, ASTM D4169 – 09, Standard Practice for Performance Testing of Shipping Containers and Systems

Reported performance (2 observations)

sensitivity0.8599CI (0.8050, 0.9041)
source quote (p.14)
“The observed performance of the CI in the clinical validation study was sensitivity of 0.8599 with 95% confidence limits of (0.8050, 0.9041)”
specificity0.7078CI (0.6588, 0.7535)
source quote (p.14)
“and specificity of 0.7078 with 95% confidence limits of (0.6588, 0.7535).”

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/K190815