Annalise Enterprise CTB Triage Trauma

K231767

Annalise-AI Pty Ltd · cleared 2023-09-22 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Annalise Enterprise CTB Triage Trauma is a software workflow tool which uses an artificial intelligence (AI) algorithm to identify suspected findings on non-contrast brain CT studies in the medical care environment.”
Algorithmconvolutional neural network trained using deep-learning techniques
source quote (p.6)
“Radiological findings are identified by the device using an AI algorithm a convolutional neural network trained using deep-learning techniques.”
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)

Retrospective clinical

n=460 cases · 5 site(s)

endpoints: sensitivity; specificity

standards: FDA's Guidance for Industry and FDA Staff, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”, May 11, 2005

Bench

n=277 cases

endpoints: triage turn-around time

Reported performance (3 observations)

sensitivity89.9CI 83.8, 94.9
source quote (p.9)
“89.9 (83.8, 94.9)”
specificity97.4CI 94.8, 99.5
source quote (p.9)
“97.4 (94.8, 99.5)”
time_to_resultas written: “triage turn-around time”81.6CI 80.3 – 82.9
source quote (p.10)
“The results demonstrated a triage turn-around time of 81.6 (95%CI: 80.3 – 82.9) seconds”

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 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/K231767