Annalise Enterprise CTB Triage Trauma

K223240

Annalise-AI Pty Ltd · cleared 2023-04-03 · 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 (3)

Bench

sample size not stated

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.

Retrospective clinical

n=3,363 cases · 5 site(s)

endpoints: standalone performance; triage effectiveness

standards: 21CFR892.2080

Bench

n=277 cases

endpoints: triage turn-around time

Reported performance (3 observations)

sensitivity91.4CI 88.1,94.4
source quote (p.10)
“91.4 (88.1,94.4)”
specificity86.7CI 79.6,92.9
source quote (p.10)
“86.7 (79.6,92.9)”
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, which is substantially equivalent to the total performance time published for the predicate device.”

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
3
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K231767 (decision 2023-09-22) from Annalise-AI Pty Ltd for a matching device line ("Annalise Enterprise CTB Triage Trauma") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K231767

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K231384 (decision 2023-09-22) from Annalise-AI Pty Ltd. for a matching device line ("Annalise Enterprise CTB Triage Trauma") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K231384

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K231094 (decision 2023-08-15) from Annalise-AI Pty Ltd for a matching device line ("Annalise Enterprise CTB Triage-OH") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K231094

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

ntap2024-10-01

NTAP max add-on $241.39 (active) ·

CMS granted NTAP beginning FY2025 (max add-on $241.39/case) for deep-learning CT-brain triage software that flags intracranial hemorrhage for worklist prioritization; billed under ICD-10-PCS XXE0X1A. Listed as continuing in the FY2026 IPPS final rule. The K-number reflects the CTB Triage Trauma 510(k); CMS's application label carried an '-OH' suffix. Facility payment only. Dollar figure read from CMS MAC Implementation File 8.

CMS FY2025 IPPS Final Rule MAC Implementation File 8CMS MEARIS NTAP publication — Annalise Enterprise CTB TriageFDA 510(k) K223240

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/K223240