Annalise Enterprise CXR Triage Pneumothorax

K213941

Annalise-AI · cleared 2022-02-24 · product code QFM · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Annalise Enterprise CXR Triage Pneumothorax is a software workflow tool that interfaces with RIS and PACS to obtain chest x-ray images to process. The artificial intelligence algorithm within the device uses deep learning techniques to identify the presence of pneumothorax and tension pneumothorax.”
Algorithmconvolutional neural network trained using deep learning techniques
source quote (p.5)
“The AI algorithm used in the device is 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 (2)

Retrospective clinical

n=949 cases · 4 site(s)

endpoints: AUC; sensitivity; specificity

Bench

n=621 cases

endpoints: triage turn-around time

Reported performance (4 observations)

sensitivity0.939CI 95% CI: 91.8, 96.1
source quote (p.8)
“The default "balanced sensitivity and specificity” operating point demonstrated sensitivity of 93.9% (95% CI: 91.8, 96.1) and specificity of 92.2% (95% CI: 89.9, 94.4) for pneumothorax and sensitivity of 94.3% (95% CI: 90.2, 98.4) and specificity of 95.8% (95% CI: 94.3, 97.1) for tension pneumothorax.”
specificity0.922CI 95% CI: 89.9, 94.4
source quote (p.8)
“The default "balanced sensitivity and specificity” operating point demonstrated sensitivity of 93.9% (95% CI: 91.8, 96.1) and specificity of 92.2% (95% CI: 89.9, 94.4) for pneumothorax and sensitivity of 94.3% (95% CI: 90.2, 98.4) and specificity of 95.8% (95% CI: 94.3, 97.1) for tension pneumothorax.”
aurocas written: “auc”0.979CI 95% CI: 0.970-0.986
source quote (p.8)
“The results included an AUC of 0.979 (95% CI: 0.970-0.986) and 0.988 (95% CI: 0.981-0.993) for pneumothorax and tension pneumothorax respectively, thus meeting the AUC>0.95 requirement for product code QFM.”
time_to_resultas written: “average triage turn-around time”20.57CI 95% CI: 19.90-21.24
source quote (p.8)
“The results demonstrated an average triage turn-around time of 20.57 seconds, (95% CI: 19.90-21.24), 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
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K250831 (decision 2025-04-23) from Annalise-AI for a matching device line ("Annalise Enterprise") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K250831

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/K213941