Annalise Enterprise CTB Triage Trauma
K231767Annalise-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.”
AlgorithmAI algorithm a convolutional 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)No
source quote (p.6)
“It is important to note that the device will never decrease a study's existing priority in the worklist. This ensures that worklist items will never have their priorities downgraded based on AI results.”
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
Bench
n=277 cases
endpoints: Triage turn-around time
Reported performance (3 observations)
sensitivity91.7CI 85.0, 98.3
source quote (p.9)
“91.7 (85.0, 98.3)”
specificity89.7CI 83.2, 95.3
source quote (p.9)
“89.7 (83.2, 95.3)”
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). 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).