SpineUs™ System

K241029

Verdure Imaging · cleared 2024-10-07 · product code IYO · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.4)
“The SpineUs ™™ system is a software-based, tracked, ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging in the following applications: musculoskeletal (conventional, superficial). The system is intended for use by trained chiropractors and radiologists in a hospital or medical clinic. The SpineUs™ System is a diagnostic ultrasound system, which consists of the FDA cleared Clarius Ultrasound Scanner C3 HD3 (K213436), a consumer PC, a tracking system with OptiTrack cameras connected to a POE switch and active LED markers, and the SpineUs™ computer application. The SpineUsT™ computer application, installed in the consumer PC, processes the ultrasound imaging data received from the Clarius Ultrasound Scanner and the tracking data received from the tracking system. The SpineUs™™ computer application allows the operator to view ultrasound images of the spine, segment the ultrasound images using artificial intelligence, generate and visualize 3D reconstructions of the surface of the spine in real-time, measure spine-related anatomical components (e.g., intervertebral angles and spine curvature), review and manage patient measurement data, and generate and export printable reports.”
AlgorithmAI-based segmentation of vertebral bone tissue in ultrasound image frames.
source quote (p.7)
“AI-based segmentation of vertebral bone tissue in ultrasound image frames.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Standalone

n=31 patients

endpoints: Sensitivity; Specificity; Precision; Dice Coefficient; Balanced Accuracy; 95th Percentile Hausdorff Distance; Percentage of transverse processes identified; Average Inference Time

standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, NEMA PS 3.1 – 3.20

Retrospective clinical

n=31 patients

endpoints: absolute value of the difference between the SpineUsTM system and X-ray-based measurements

standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, NEMA PS 3.1 – 3.20

Reported performance (5 observations)

sensitivity0.418
source quote (p.11)
“Sensitivity: 41.80%.”
specificity0.9919
source quote (p.11)
“Specificity: 99.19%.”
ppvas written: “Precision”0.387
source quote (p.11)
“Precision: 38.70%.”
diceas written: “Dice Coefficient”0.4019
source quote (p.11)
“Dice Coefficient: 0.4019.”
accuracyas written: “Balanced accuracy”0.7049
source quote (p.11)
“Balanced accuracy: 70.49%.”

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

8
recalls in product code, 24mo
344
MAUDE reports in code, 12mo
-40%
vs code's own 3-yr baseline
1
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code IYO (Civco Medical Instruments Co. Inc., initiated 2026-03-02): "There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified " Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98513

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 Radiology 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/K241029