autoSCORE

K231068

Holberg EEG AS · cleared 2024-01-07 · product code OMB · Neurology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“autoSCORE is a software-only decision support product intended to be used with compatible electroencephalography (EEG) review software.”
AlgorithmConvolutional Neural Network trained with standard deep learning principles
source quote (p.6)
“autoSCORE uses an algorithm that has been trained with standard deep learning principles using a large training dataset.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (6)

Bench

sample size not stated

endpoints: Code Review; Unit level testing; System level testing; Integration level testing

standards: 2005 FDA Guidance, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

Retrospective clinical

n=4,850 cases · 1 site(s)

endpoints: sensitivity; specificity; PPV; NPV; correlation coefficient

Retrospective clinical

n=100 cases · 16 site(s)

endpoints: sensitivity; specificity; PPV; NPV; correlation coefficient

Retrospective clinical

n=100 cases · 16 site(s)

endpoints: accuracy; sensitivity; specificity; NPV; PPV

Retrospective clinical

n=58 cases · 4 site(s)

endpoints: accuracy; sensitivity; specificity; NPV; PPV; correlation coefficient

Retrospective clinical

n=1,315 cases · 2 site(s)

endpoints: sensitivity; specificity; PPV; NPV; correlation coefficient

Reported performance (4 observations)

sensitivity0.831CI 81.3, 84.8
source quote (p.19)
“83.1 [81.3, 84.8]”
specificity0.918CI 90.8, 92.8
source quote (p.19)
“91.8 [90.8, 92.8]”
ppvas written: “PPV”0.849CI 83.2, 86.6
source quote (p.19)
“84.9 [83.2, 86.6]”
npvas written: “NPV”0.908CI 89.8, 91.8
source quote (p.19)
“90.8 [89.8, 91.8]”

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
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K243743 (decision 2025-04-09) from Holberg EEG AS for a matching device line ("autoSCORE (V 2.0.0)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K243743

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/K231068