Annalise Enterprise CXR Triage Trauma
K222268Annalise-AI Pty Ltd · cleared 2023-03-28 · product code QFM · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.5)
“Annalise Enterprise CXR Triage Trauma is a software workflow tool which uses an artificial intelligence (AI) algorithm to identify suspected findings on chest X-ray (CXR) studies in the medical care environment.”
AlgorithmAI algorithm a convolutional neural network trained using deep-learning techniques
source quote (p.5)
“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=589 cases · 4 site(s)
endpoints: Sensitivity; Specificity; AUC; Triage effectiveness (turn-around time)
Reported performance (4 observations)
sensitivity89.3CI 85.7-93.0
source quote (p.7)
“89.3 (85.7-93.0)”
specificity89CI 85.8-92.1
source quote (p.7)
“89.0 (85.8-92.1)”
aurocas written: “auc”0.954CI 95% CI: 0.939-0.968
source quote (p.7)
“AUC: 0.954 (95% CI: 0.939-0.968)”
time_to_resultas written: “triage turn-around time”30
source quote (p.8)
“The results demonstrated an average triage turn-around time of 30.0 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).