Nerveblox

K250818

Smart Alfa Teknoloji San. Ve Tic. A.S. · cleared 2025-08-15 · product code QRG · Anesthesiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Nerveblox is a software as a medical device, designed to assist clinicians in identifying anatomy for ultrasound-guided peripheral nerve blocks.”
Algorithmnon-adaptive AI/ML functionalities; convolutional neural networks (CNNs)
source quote (p.6)
“Nerveblox utilizes non-adaptive Al/ML functionalities to highlight anatomical structures by applying color overlays, adding name labels, and providing a quality score that informs the user about the overall image's suitability for anatomical assessment and the completeness level of detected anatomy regarding the key anatomical structures. Both the subject device and the predicate device utilize convolutional neural networks (CNNs) for their Al algorithms to identify and label anatomical structures on ultrasound images.”
Adaptive (vs locked)No
source quote (p.6)
“Nerveblox utilizes non-adaptive Al/ML functionalities to highlight anatomical structures by applying color overlays, adding name labels, and providing a quality score that informs the user about the overall image's suitability for anatomical assessment and the completeness level of detected anatomy regarding the key anatomical structures.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.14)
“All software/cybersecurity tests have been successfully completed without any anomalies”

Validation studies (2)

Prospective clinical

n=40 patients

endpoints: accuracy of Nerveblox in detecting and highlighting key anatomical structures; consistency of the AI's image quality grading against predefined criteria; identifying potential risks in AI-assisted interpretation

Reader study (MRMC)

n=22 other · 3 site(s)

endpoints: use errors; difficulty with use; close call; task failure

Reported performance (5 observations)

sensitivity0.98
source quote (p.16)
“The software demonstrated a high accuracy rate of 97%, with a true positive rate of 98% and a true negative rate of 90%.”
specificity0.9
source quote (p.16)
“The software demonstrated a high accuracy rate of 97%, with a true positive rate of 98% and a true negative rate of 90%.”
accuracyas written: “Accuracy (TP+TN)”0.972
source quote (p.14)
“Accuracy (TP+TN): 97.2% (933 out of 960 scans)”
accuracyas written: “Accuracy of identifying the correct block region”0.953
source quote (p.14)
“Accuracy of identifying the correct block region 95.3%”
agreement_kappaas written: “Weighted Kappa Coefficient (к)”stated without valueCI ≥ 0.77; ranged from 0.77 to 0.98
source quote (p.14)
“Weighted Kappa Coefficient (к) ≥ 0.77 Weighted Kappa values ranged from 0.77 to 0.98 across all block regions, indicating substantial agreement with expert assessments.”

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

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 Anesthesiology 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/K250818