SafeOp 3: Neural Informatix System

K252842

Alphatec Spine, Inc. · cleared 2026-01-11 · product code GWF · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The SafeOpTM 3: Neural Informatix System (SafeOp 3 System), consists of the SafeOp patient interface with power supply and IV pole mount, the Alpha Informatix Tablet with docking station and power supply and a data transfer USB cable. Associated disposable accessories consists of an electrode harness, surface and/or subdermal needle electrodes, MEP Activator, Cranial Hub, Delta Dilators and Stimulating Probe and Delta Clip contained in various kits. The PCCP for the SafeOp 3 System includes the following planned software and algorithmic modifications, which will be implemented under documented design control procedure.”
AlgorithmSSEP Baseline Classification Algorithm
source quote (p.10)
“Modification #1 - Stimulation site specific SSEP Baseline Classification Algorithm The system's SSEP baseline classification algorithm will be re-trained using site-specific data from the posterior tibial, saphenous, and ulnar nerves. Dedicated classifiers for each stimulation site are expected to improve robustness and performance while maintaining the algorithm's existing inputs, outputs, and intended use.”
Adaptive (vs locked)Yes
source quote (p.10)
“Modification #4 – Ongoing Maintenance and Update of the SSEP Baseline Classification Algorithm The stimulation site-specific SSEP classifiers may be periodically re-trained as additional labeled data become available.”
PCCPYes
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

Standalone

sample size not stated

Reported performance (3 observations)

ppvas written: “Positive Predictive Value (PPV)”90
source quote (p.10)
“The modified SSEP baseline classification algorithm must meet overall PPV ≥ 90%, overall accuracy and F1-score ≥ 85%.”
accuracyas written: “Accuracy”85
source quote (p.10)
“The modified SSEP baseline classification algorithm must meet overall PPV ≥ 90%, overall accuracy and F1-score ≥ 85%.”
f1as written: “F1-score”85
source quote (p.10)
“The modified SSEP baseline classification algorithm must meet overall PPV ≥ 90%, overall accuracy and F1-score ≥ 85%.”

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

1
recalls in product code, 24mo
904
MAUDE reports in code, 12mo
+75%
vs code's own 3-yr baseline
1
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code GWF (Medtronic Xomed, Inc., initiated 2025-03-10): "Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:96511

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/K252842