BU-CAD
K210670TaiHao Medical Inc. · cleared 2021-12-21 · product code QDQ · Radiology
Premarket evidence — what FDA accepted
source quote (p.20)
“BU-CAD is a software-only device.”
source quote (p.9)
“Both BU-CAD and TransparaTM are intended to identify regions suspicious for breast cancer and provide computer analytics that are then synthesized by an artificial intelligence algorithm into a single value.”
source quote (p.20)
“Draft Guidance for Industry and Food and Drug Administration Staff - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.”
Validation studies (3)
Reader study (MRMC)
n=628 cases · 2 site(s)
endpoints: AUC of location-specific ROC; identify the lesion; provide a linear score of lesion characteristics (SLC); select a BI-RADS category; select BI-RADS descriptors; sensitivity; specificity; PPV; NPV
Standalone
n=1,139 cases
Bench
n=1,139 cases
endpoints: AUC stability
Reported performance (6 observations)
source quote (p.18)
“Sensitivity (%): 88.33 (439/497) (0.8551, 0.9115)”
source quote (p.18)
“Specificity (%): 57.94 (372/642) (0.5413, 0.6176)”
source quote (p.17)
“BU-CAD Standalone (1,139 standalone study cases) AUC LROC 0.8203 (0.7947, 0.8458)”
source quote (p.16)
“The accuracy of the lesion identification algorithm was 93.24% (1062/1139).”
source quote (p.18)
“PPV (%) [unadjusted] 61.92 (439/709) (0.5834, 0.6549)”
source quote (p.18)
“NPV (%) [unadjusted] 86.51 (372/430) (0.8328, 0.8974)”
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
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).