ProFound Detection (V4.0)
K240417iCAD, Inc. · cleared 2024-11-08 · product code QDQ · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.4)
“ProFound Detection V4.0 is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while reading digital breast tomosynthesis (DBT) exams from compatible DBT systems.”
Algorithmneural network architecture
source quote (p.9)
“This has been accomplished by changing the neural network architecture for each subsystem and retraining the model, and by the processing of prior images when they are available.”
Adaptive (vs locked)No
source quote (p.8)
“In accordance with the PCCP, the CAD algorithm will be trained, tuned, and locked prior to commercial release of the algorithm with the extended DBT image acquisition system(s) listed in the PCCP.”
PCCPYes
source quote (p.8)
“The subject device includes a Predetermined Change Control Plan (PCCP) that extends supported DBT image acquisition systems. In accordance with the PCCP, the CAD algorithm will be trained, tuned, and locked prior to commercial release of the algorithm with the extended DBT image acquisition system(s) listed in the PCCP.”
Cybersecurity addressedFDA source did not state this
Validation studies (1)
Standalone
n=952 cases
endpoints: Sensitivity; False Positives Per Image (FPPI); Area Under the ROC Curve (AUC)
Reported performance (3 observations)
sensitivity0.9004CI 0.8633-0.9374
source quote (p.9)
“0.9004 (0.8633-0.9374)”
specificity0.5863CI 0.5498-0.6228
source quote (p.9)
“0.5863 (0.5498-0.6228)”
aurocas written: “auc”0.8714CI 0.8423-0.9007
source quote (p.9)
“0.8714 (0.8423-0.9007)”
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).