Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial

K223864

Brainlab AG · cleared 2023-09-09 · product code HAW · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“For this purpose, the Alignment System Cranial consists of a combination of hardware and software.With this submission, an already existing feature is now performed introducing a new algorithm using artificial intelligence and machine learning (AI/ML).”
AlgorithmConvolutional Neuronal Network (CNN) developed using a Supervised Learning approach
source quote (p.5)
“The AI/ML algorithm is a Convolutional Neuronal Network (CNN) developed using a Supervised Learning approach.”
Adaptive (vs locked)No
source quote (p.5)
“The test pool data is set aside at the beginning of the project. This is a static algorithm (locked).”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.9)
“Compliance to electrical safety, RFID and EMC was evaluated on the Subject device according to the standards: IEC 60601-1, AIM 7351731 and IEC 60601-1-2. The tests have shown that the subject device performs as intended.”

Validation studies (3)

Bench

sample size not stated

endpoints: product specifications; risk analysis; incremental test strategies

standards: FDA's Guidance for Industry and FDA Staff, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Bench

sample size not stated

endpoints: validate the new use scenarios: Varioguide for biopsy and Cirq for sEEG workflows; guidance provided by the updated Alignment Software Cranial; handling of instruments or the assembly of the positioning devices; overall focus on new or changed features; final designs were proven safe and effective for use in the defined use scenarios

standards: IEC 62366-1 "Medical devices - Part 1: Application of usability engineering to medical devices"

Bench

sample size not stated

endpoints: Mean Positional Error of the placed instrument's tip ","Mean Angular Error of the placed instrument's axis

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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

5
recalls in product code, 24mo
1922
MAUDE reports in code, 12mo
-39%
vs code's own 3-yr baseline
1
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code HAW (Howmedica Osteonics Corp., initiated 2025-11-12): "When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an in" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97988

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/K223864