Annalise Enterprise CXR Triage Trauma

K222268

Annalise-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.”
Algorithmconvolutional 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: AUC; Sensitivity; Specificity; 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 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); 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/K222268