PowerLook Tomo Detection V2 Software
K182373iCAD Inc. · cleared 2018-12-06 · product code QDQ · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“PowerLook® Tomo Detection V2 Software 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.”
source quote (p.5)
“The PowerLook Tomo Detection V2 algorithm uses deep learning technology to process feature computations and uses pattern recognition to identify suspicious breast lesions appearing as soft tissue densities or clusters of calcifications.”
source quote (p.6)
“Certainty of Finding and Case Scores are not calibrated to the prevalence in the intended use population or to the prevalence in the pivotal reader study outlined in the Assessment of Clinical Performance Data section, and consequently, the Certainty of Finding and Case Scores are in general higher than the actual probability of malignancy in an intended use population with less than 50% prevalence.”
Validation studies (3)
Standalone
n=655 cases
endpoints: Case-Level Sensitivity; Lesion-Level Sensitivity; FP Rate in Non-Cancer Cases; Specificity
Standalone
n=610 cases
endpoints: Case-Level Sensitivity; Lesion-Level Sensitivity; FP Rate in Non-Cancer Cases; Specificity
Reader study (MRMC)
n=260 cases
endpoints: Whether radiologist performance when using CAD with DBT images is non-inferior to radiologist performance when using DBT images without CAD; Whether radiologist reading time when using CAD with DBT images is superior to (shorter than) radiologist reading time when using DBT images without CAD; Superiority of case-level AUC; Non-inferiority (with non-inferiority margin delta = 0.05) of sensitivity at the case level; Superiority of sensitivity at the case level; Non-inferiority (with non-inferiority margin delta = 0.05) of sensitivity at the lesion level; Superiority of sensitivity at the lesion level; Non-inferiority (with non-inferiority margin delta = 0.05) of specificity (case-level); Non-inferiority (with non-inferiority margin delta = 0.05) of recall rate in non-cancers (case-level)
Reported performance (12 observations)
source quote (p.11)
“Average case-level sensitivity was 0.770 without CAD and 0.850 with CAD.”
source quote (p.11)
“Specificity was 0.627 without CAD and 0.696 with CAD, for an average increase of 0.069 (95% CI: 0.030, 0.108; non-inferiority p < 0.01 for non-inferiority margin delta = 0.05).”
source quote (p.11)
“Radiologists had superior per-subject average area under the receiver operating characteristic (ROC) curve (AUC) with CAD, 0.852, versus without CAD, 0.795.”
source quote (p.11)
“The average difference in AUC was 0.057 (95% CI: 0.028, 0.087; non-inferiority p < 0.01 for non-inferiority margin delta = 0.05, and p < 0.01 for test of difference).”
source quote (p.11)
“Average sensitivity increased by 0.080 (95% CI: 0.026, 0.134; non-inferiority p < 0.01 for non-inferiority margin delta = 0.05, and p < 0.01 for test of difference).”
source quote (p.11)
“At the lesion level, radiologists also had superior sensitivity with CAD. Average per-lesion sensitivity across readers increased by 0.084 (95% CI: 0.029, 0.139; non-inferiority p < 0.01 for non-inferiority margin delta = 0.05, and p < 0.01 for test of difference), from 0.769 without CAD to 0.853 with CAD.”
source quote (p.11)
“Average recall rate in non-cancer cases was 0.380 without CAD and 0.309 with CAD, for an average reduction of 0.072 (95% CI: 0.031, 0.112; non-inferiority p < 0.01 for non-inferiority margin delta = 0.05).”
source quote (p.11)
“Average sensitivity increased by 0.120 (SE=0.040) in the subgroup of 15 cancer cases with only calcifications.”
source quote (p.11)
“Average sensitivity increased by 0.068 (SE=0.031) in the subgroup of 50 cancer cases with at least one soft tissue density or mixed lesion.”
source quote (p.12)
“Average specificity decreased by 0.027 (SE=0.038) in the subgroup of 24 benign and recalled (non-cancer) cases with only calcifications.”
source quote (p.12)
“Average specificity increased by 0.079 (SE=0.028) in the subgroup of 62 benign and recalled (non-cancer) cases with at least one soft tissue density or mixed lesion.”
source quote (p.12)
“Average specificity increased by 0.084 (SE=0.021) in the subgroup of 109 non-cancer cases with no lesions.”
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).