Annalise Enterprise CTB Triage Trauma
K231384Annalise-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)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this
Validation studies (1)
Retrospective clinical
n=1,388 cases
endpoints: triage turn-around time
Reported performance (3 observations)
sensitivity97CI 95.3,98.4
source quote (p.9)
“97.0 (95.3,98.4)”
specificity88.7CI 83.5,94.0
source quote (p.9)
“88.7 (83.5,94.0)”
time_to_resultas written: “triage turn-around time”81.6CI 80.3 82.9
source quote (p.9)
“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).