NeuroMatch

K241390

LVIS Corporation · cleared 2024-11-26 · product code OMB · Neurology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“NeuroMatch is a cloud-based software as a medical device (SaMD) intended to review, monitor, display, and analyze previously acquired and/or near real-time electroencephalogram (EEG) data from patients 18 years old or older.”
Algorithmdeep learning-based algorithm
source quote (p.7)
“The NeuroMatch Spike Detection feature uses a deep learning-based algorithm that detects potential epileptiform spikes and annotates each detected potential spike with a unique identification.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.14)
“A comprehensive battery of cybersecurity testing per FDA's guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (issued September 2023), including Configuration Assessment, Vulnerability Scanning, and Penetration Testing, was conducted.”

Validation studies (2)

Retrospective clinical

n=181 patients · 3 site(s)

endpoints: non-inferiority to the predicate device based on both sensitivity and false detection rate (FDR)

Retrospective clinical

n=149 patients · 3 site(s)

endpoints: non-inferiority to the performance of the predicate device in terms of sensitivity and false detection rate

Reported performance (3 observations)

sensitivity75.01CI [72.62, 77.57]
source quote (p.16)
“NeuroMatch 75.01 [72.62, 77.57]”
detection_rateas written: “False Detection Rate (FDR) (per 24 hrs)”3.74CI [2.59, 5.44]
source quote (p.16)
“NeuroMatch 3.74 [2.59, 5.44]”
detection_rateas written: “False Detection Rate (FDR) (per minute)”3.24CI [2.15, 4.33]
source quote (p.17)
“NeuroMatch 3.24 [2.15, 4.33]”

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
-100%
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/K241390