autoSCORE (V 2.0.0)

K243743

Holberg EEG AS · cleared 2025-04-09 · product code OMB · Neurology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“autoSCORE is a software only device.”
AlgorithmAI model trained with standard deep learning principles, a subset of Artificial Intelligence and Machine Learning methodologies, which uses artificial neural networks for data analysis.
source quote (p.6)
“autoSCORE is an Al model that has been trained with standard deep learning principles using a large training dataset. ... Deep Learning is a subset of the Artificial Intelligence and Machine Learning methodologies, which uses artificial neural networks for data analysis.”
Adaptive (vs locked)No
source quote (p.6)
“The model will be locked in the field, so it cannot learn from data to which it is exposed when in use.”
PCCPFDA source did not state this
Cybersecurity addressedNo
source quote (p.22)
“autoSCORE is a software only device. Biocompatibility, electrical safety, electromagnetic compatibility, mechanical and acoustic testing is not applicable.”

Validation studies (1)

Retrospective clinical

n=80 images

endpoints: Sensitivity (TPR); Specificity (TNR); Positive Predictive Value (PPV); Negative Predictive Value (NPV); Accuracy

standards: FDA Guidance for Industry and FDA Staff, Guidance for the Content of Software Contained in Medical Devices

Reported performance (10 observations)

sensitivity0.926CI 0.859, 0.985
source quote (p.18)
“0.926 (0.859, 0985)”
specificity0.833CI 0.583, 1.000
source quote (p.18)
“0.833 (0.583, 1.000)”
accuracyas written: “Accuracy (ACC) for Abnormal”0.912CI 0.850, 0.963
source quote (p.18)
“0.912 (0.850, 0.963)”
ppvas written: “Precision (PPV) for Abnormal”0.969CI 0.922, 1.000
source quote (p.18)
“0.969 (0.922, 1.000)”
npvas written: “NPV for Abnormal”0.666CI 0.412, 0.905
source quote (p.18)
“0.666 (0.412, 0.905)”
ppvas written: “PPV for Focal Epi”0.56CI 0.526, 0.594
source quote (p.21)
“0.560 (0.526, 0.594)”
ppvas written: “PPV for Gen Epi”0.446CI 0.405, 0.486
source quote (p.21)
“0.446 (0.405, 0.486)”
ppvas written: “PPV for Focal Non-Epi”0.823CI 0.794, 0.852
source quote (p.21)
“0.823 (0.794, 0.852)”
ppvas written: “PPV for Diff Non-Epi”0.849CI 0.822, 0.876
source quote (p.21)
“0.849 (0.822, 0.876)”
ppvas written: “PPV for IED”0.513CI 0.486, 0.539
source quote (p.21)
“0.513 (0.486, 0.539)”

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/K243743