Patient-Assisted Compression - Impact on Image Quality and Workflow

Patient-assisted (PA) compression allows the patient to participate in controlling the amount
of compression force during mammography and is a personalized approach that has demonstrated
successful reduction in discomfort experienced during mammography. GE Healthcare's Senographe
Pristina, an innovative mammography platform that provides both two-dimensional (2D) and
three-dimensional (3D) imaging capabilities, offers both standard and PA compression modes.
This study is being conducted to compare the image quality of breast images obtained using TC
compression and PA compression, and to evaluate the impact of PA compression on clinical
workflow. The study population will consist of adult asymptomatic women presenting for
screening 2D mammography.

Inclusion Criteria:

- Are women aged 40 years or older;

- Are asymptomatic and scheduled for FFDM screening mammography;

- Have left and right breasts;

- Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector,
without anatomical cut-off;

- Are documented as non-pregnant based on the investigator's medical judgment and in
consideration of local clinical practice standards for evidence of non-pregnancy;

- Are able and willing to comply with study procedures; and

- Are able and willing to provide written informed consent to participate.

Exclusion Criteria:

- Have been previously included in this study or are participating in another study
expected to interfere with study procedures or outcomes;

- Have undergone diagnostic or surgical intervention(s) or procedure(s) on either
breast, including breast biopsy, lumpectomy, or reconstruction, within five (5) years
(≤ 5 years) of the study exam date;

- Are currently undergoing radiotherapy or chemotherapy, or have a history of prior
radiotherapy treatment on either breast;

- Are currently lactating; or

- Have breast implants.