Bunkerhill Contrast CAC

Bunkerhill Contrast CAC is a software device that automatically analyzes non-gated, contrast-enhanced chest CT images to detect the presence and estimate the quantity of coronary artery calcification in patients aged 30 and above. It outputs a quantification score in cubic millimeters (mm³) and a visual region of interest, intended as an adjunctive tool to assist physicians in reviewing patient cases rather than as a standalone diagnostic.

Both the subject device and predicate use deep-learning algorithms to identify and quantify calcification in non-gated CT images in DICOM format. The key difference is that the subject device analyzes contrast-enhanced images and outputs volume in mm³ using a deterministic formula, whereas the predicate analyzes non-contrast images and outputs Agatston Units. Both provide visual regions of interest and serve as optional support tools that do not replace clinical evaluation.

Not stated in this summary.

Bunkerhill Contrast CAC is substantially equivalent to the predicate iCAC Device (K230223) because both devices use identical principles of operation and technological characteristics for detecting and quantifying calcification. The pivotal retrospective validation study demonstrated sensitivity of 0.957, specificity of 0.929, and acceptable Bland-Altman agreement (mean bias 25.41 mm³, LOA –249.13 to 198.32 mm³). A bridging study comparing contrast-enhanced and non-contrast images on the same patients confirmed validity (mean bias –4.36 mm³), with minor differences in image type and output units not raising new safety or effectiveness concerns.