Automatic Registration

K234047

Brainlab AG · cleared 2024-03-20 · product code OLO · Neurology

Premarket evidence — what FDA accepted

Device typesimd
source quote (p.3)
“Automatic Registration is a software device for image guided surgery intended to be used in combination with compatible Brainlab navigation systems such as the Brainlab Spine & Trauma Navigation System.”
AlgorithmConvolutional Neural network (CNN) developed using a Supervised Learning approach
source quote (p.7)
“The AI/ML algorithm used in the new registration method is a Convolutional Neural network (CNN) developed using a Supervised Learning approach.”
Adaptive (vs locked)No
source quote (p.7)
“This is a static algorithm (locked).”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.7)
“Software verification and validation testing has been conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, “Content of Premarket Submissions for Device Software Functions". These include successful implementation of product specifications, incremental testing for different release candidates, testing of risk control measures, compatibility testing or cybersecurity tests.”

Validation studies (2)

Bench

sample size not stated

endpoints: Registration accuracy; mean navigation accuracy with 3D deviation

Bench

n=15 other

endpoints: identification of critical use related problems

Reported performance (2 observations)

accuracyas written: “Registration accuracy (P95)”2.5
source quote (p.7)
“Registration accuracy of ≤ 2.5 mm (P95, i.e. within the 95th percentile)”
accuracyas written: “Mean navigation accuracy with 3D deviation”1.5
source quote (p.7)
“with a mean navigation accuracy with 3D deviation ≤ 1.5 mm.”

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

25
recalls in product code, 24mo
2666
MAUDE reports in code, 12mo
+26%
vs code's own 3-yr baseline
4
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code OLO (, initiated 2025-12-10): "Software errors that can result in incorrect surgical instrument positioning during spinal surgery." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98199

  • recall_reason_pattern

    Software/algorithm-related recall in product code OLO (Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France, initiated 2025-03-05): "Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance proh" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:96437

  • recall_reason_pattern

    Software/algorithm-related recall in product code OLO (Medtronic Navigation, Inc., initiated 2024-08-22): "Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, informat" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95283

  • recall_reason_pattern

    Software/algorithm-related recall in product code OLO (, initiated 2024-07-17): "Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and t" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95189

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/K234047