Regulatory evidence record · Alphatec Spine
SafeOp 3: Neural Informatix System
Intraoperative neurophysiological monitoring supporting SSEP, MEP, train-of-four, triggered EMG, and free-run EMG workflows, with an SSEP baseline-classification algorithm.
Original dossier: FDA 510(k) K252842 · Jan 11, 2026
Anonymous editorial source review; independent professional peer review is not claimed. Page updates do not reset evidence dates.
What the cited dossier supports
The summary documents nonclinical validation and a change-control plan requiring updated SSEP classifiers to meet PPV ≥90% and accuracy and F1 score ≥85%.
Clinical boundary
The public file supports technical performance and controlled model updates, not comparative evidence of fewer neurological injuries or better patient outcomes.
Inclusion is not endorsement; clearance does not establish superior clinical outcomes.
Sources and check history
Sources checked Sep 6, 2026; this is the evidence-search date, not the page-update date.
Source check · Sep 6, 2026
The cited clearance and intended use were confirmed. PPV, accuracy and F1 values are acceptance criteria for planned classifier changes under the PCCP, not observed patient-outcome results. The recall is a separate postmarket finding.
UDI-DI 00190376517506; System Set ID / Patient Interface serial: 2007716 / DG106225, 2005498 / DG106220, 2005490 / DG106230. The FDA record reports replacement systems were provided and instructs affected customers to stop using and return the specified devices. Consult the current official notice and manufacturer to determine applicability; do not infer injury rates from a recall record.
FDA database record K252842 · Decision Jan 11, 2026.
Source locations: FDA PDF pp. 4, 10–11 (summary pp. 6–7 for PCCP and performance).
A matched recall is shown above. Recall queries used the listed 510(k) identifiers and product/manufacturer names. The retrieved openFDA recall dataset was last updated September 3, 2026. A missing match does not establish that a device is free of recalls, adverse events, or risk; reporting and indexing can lag.
No product-matched patient-outcome study published August 17–September 6, 2026 was verified in this targeted search. This is a search result, not proof that no new evidence exists. Older or differently named systems and company announcements were not treated as evidence of benefit for the listed version.
Targeted check of FDA decision records, cited summary sections, device-linked recall records, and indexed clinical literature. This is not a systematic review or continuous safety surveillance. Next planned safety scan: Oct 6, 2026. This check does not reset the original summary-review date.
Original FDA decision and summary (PDF)
Original summary reviewed Aug 17, 2026 · Next scheduled full regulatory review Nov 17, 2026.
Index inclusion and evidence methodology
Editorial responsibility: Neurosurgery.ai (anonymous site-name attribution). Editorial policy.