Accuro 3S

K243937

Rivanna Medical, Inc. · cleared 2025-05-23 · product code IYO · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.5)

“The Accuro® 3S is an ultrasound imaging device intended for use by qualified and trained healthcare professionals in hospital or medical clinic environments. The device offers B-mode imaging and a SpineNav-Al™™ image processing software.”

Algorithmdeep convolutional neural network approach

source quote (p.7)

“The machine learning algorithm at the foundation of SpineNav-AI is a deep convolutional neural network approach to segmenting certain anatomical structures in the lumbar spine and conveying them by way of graphics to the user.”

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)

Bench

sample size not stated

standards: 21 CFR 820, ISO 14971:2019, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers- Guidance for Industry and Food and Drug Administration Staff, issued on February 21, 2023, IEC 60601-1 Edition 3.2 2020-08, IEC 60601-1-2 Edition 4.1 2020-09, IEC 60601-1-6 Edition 3.2 2020-07, IEC 60601-2-37 Edition 2.1 2015, IEC 62304, Edition 1.1 2015-06, IEC 62366-1 Edition 1.1 2020-06, IEC 62359 Edition 2.1 2017-09, ISO 10993-1 Fifth edition 2018, ISO 14971 Third edition 2019-12, NEMA UD 2-2004 (R2009), NEMA PS 3.1 - 3.20e, AAMI TIR69:2017(R2020)

Retrospective clinical

n=81 patients · 7 site(s)

endpoints: per-frame accuracy; per-sequence detection success rate; DICE; Epidural Region Indicator accuracy; Per-frame detection success rate of the Epidural Region Indicator

standards: ISO 14971

Reported performance (4 observations)

accuracyas written: “per-frame accuracy for all anatomical structures”stated without valueCI 82.1% - 99.3%

source quote (p.8)

“The range of per-frame accuracy for all anatomical structures was 82.1% - 99.3%;”

diceas written: “DICE scores for all anatomical structures”stated without valueCI 0.64 - 0.87

source quote (p.8)

“and the range of DICE scores for all anatomical structures was 0.64 - 0.87.”

accuracyas written: “Epidural Region Indicator accuracy (lateral dimension)”1.61CI ± 2.57 mm

source quote (p.9)

“The Epidural Region Indicator, derived from SpineNav-Al anatomical segmentations, demonstrated accuracy of 1.61 (± 2.57) mm and 2.42 (± 3.41) mm in the lateral and depth dimensions, respectively, compared to the radiologist panel ground truth.”

accuracyas written: “Epidural Region Indicator accuracy (depth dimension)”2.42CI ± 3.41 mm

source quote (p.9)

“The Epidural Region Indicator, derived from SpineNav-Al anatomical segmentations, demonstrated accuracy of 1.61 (± 2.57) mm and 2.42 (± 3.41) mm in the lateral and depth dimensions, respectively, compared to the radiologist panel ground truth.”

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

recalls in product code, 24mo

344

MAUDE reports in code, 12mo

-40%

vs code's own 3-yr baseline

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). 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).