xvision Spine System

K241481

Augmedics Ltd. · cleared 2024-10-16 · product code SBF · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“The xvision Spine System (XVS) is an image-guided navigation system designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery by displaying stereoscopic augmented reality (AR) navigation information onto the patient anatomy. The system consists of dedicated software running on a PC, a headset, single use passive reflective markers, and reusable components. It uses wireless optical tracking technology and displays to the surgeon the location of the tracked surgical instruments relative to the acquired patient's scan, onto the surgical field.”
Algorithmdeep learning-based spine segmentation algorithm based on CNN architecture
source quote (p.6)
“As part of the development of this registration method, the company developed a new software algorithm that includes a deep learning-based spine segmentation algorithm that segments individual vertebrae including the sacrum and ilium. The segmentation output is used as an input to the new registration algorithm. The added algorithm is based on the same CNN architecture as the full spine segmentation algorithm.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (5)

Bench

n=3 other

endpoints: positional errors; trajectory errors; Gertzbein-Robbins score

Bench

sample size not stated

endpoints: Registration accuracy; overall system accuracy

Standalone

n=1 scans

endpoints: mean Dice coefficient

Bench

sample size not stated

standards: IEC 62304

Bench

sample size not stated

endpoints: user needs and intended use requirements were met

standards: IEC 62366-1:2015

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

1
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
3
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K251639 (decision 2025-10-03) from Augmedics, Ltd. for a matching device line ("xvision Spine system") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K251639

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K250255 (decision 2025-03-13) from Augmedics Ltd. for a matching device line ("xvision Spine system") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K250255

  • recall_reason_pattern

    Software/algorithm-related recall in product code SBF (Kico Knee Innovation Company, initiated 2025-09-19): "Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97618

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/K241481