Critical Care Suite with Endotracheal Tube Positing AI algorithm
K211161GE Medical Systems, LLC · cleared 2021-10-29 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.3)
“Critical Care Suite is a suite of AI algorithms for the automated image analysis of frontal chest X-rays acquired on a digital x-ray system.”
Algorithmdeep learning locked Al algorithm
source quote (p.7)
“It is a deep learning locked Al algorithm that can be deployed on several computing platforms such as PACS, On Premise, On Cloud or Imaging Systems.”
Adaptive (vs locked)No
source quote (p.7)
“It is a deep learning locked Al algorithm that can be deployed on several computing platforms such as PACS, On Premise, On Cloud or Imaging Systems.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this
Validation studies (2)
Bench
sample size not stated
Retrospective clinical
sample size not stated
endpoints: primary and secondary endpoints
Reported performance (3 observations)
sensitivity0.9941CI 0.9859, 1.0000
source quote (p.9)
“a sensitivity of 0.9941 (0.9859, 1.0000) for ETT detection.”
specificity1CI 1.0000, 1.0000
source quote (p.9)
“and a specificity of 1.0000 (1.0000, 1.0000) for ETT detection.”
aurocas written: “auc”0.9999CI 0.9998, 1.0000
source quote (p.9)
“The Endotracheal Tube Positioning Al Algorithm achieved an AUC of 0.9999 (0.9998, 1.0000)”
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
3
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).