#### PURPOSE:

For the last few years, development and optimization of three-dimensional (3D) x-ray breast imaging systems, such as digital breast tomosynthesis (DBT) and computed tomography, have drawn much attention from the medical imaging community, either academia or industry. However, there is still much room for understanding how to best optimize and evaluate the devices over a large space of many different system parameters and geometries. Current evaluation methods, which work well for 2D systems, do not incorporate the depth information from the 3D imaging systems. Therefore, it is critical to develop a statistically sound evaluation method to investigate the usefulness of inclusion of depth and background-variability information into the assessment and optimization of the 3D systems.

#### METHODS:

In this paper, we present a mathematical framework for a statistical assessment of planar and 3D x-ray breast imaging systems. Our method is based on statistical decision theory, in particular, making use of the ideal linear observer called the Hotelling observer. We also present a physical phantom that consists of spheres of different sizes and materials for producing an ensemble of randomly varying backgrounds to be imaged for a given patient class. Lastly, we demonstrate our evaluation method in comparing laboratory mammography and three-angle DBT systems for signal detection tasks using the phantom's projection data. We compare the variable phantom case to that of a phantom of the same dimensions filled with water, which we call the uniform phantom, based on the performance of the Hotelling observer as a function of signal size and intensity.

#### RESULTS:

Detectability trends calculated using the variable and uniform phantom methods are different from each other for both mammography and DBT systems.

#### CONCLUSIONS:

Our results indicate that measuring the system's detection performance with consideration of background variability may lead to differences in system performance estimates and comparisons. For the assessment of 3D systems, to accurately determine trade offs between image quality and radiation dose, it is critical to incorporate randomness arising from the imaging chain including background variability into system performance calculations.

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