Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle

The Universal Pain Assessment Tool (UPAT) was used to assess each subject's comfort perception with each paddle (SOC and INV). The UPAT ranges from 0 to 10, where 0 represents 'no pain' and 10 'worst pain possible'.

Time frame: 1 day (Day of procedure, No follow-up)

Population: The number of participants analyzed per group differs from the number provided in the Participant Flow module (429).~Two subjects' pain scores were unclear when imaged with the INV paddle. For this reason, the analysis was done by contemplating 427 subjects.~Three subjects' pain scores were unclear when imaged with the INV paddle. For this reason, the analysis was done by contemplating 426 subjects.

An expert technologist evaluated the performance of the SOC and the INV paddles in 388 subjects. For each participant, the technologist answered which paddle was better at pulling in more breast tissue during imaging between SOC and INV (all subjects were imaged with both paddles during the same session). The technologist rated the paddles using a 5-point Likert scale, where -2 and -1 values mean that the SOC paddle performed better or slightly better, 0 means equal performance between paddles, and 2 and 1 mean that the INV performed better or slightly better than the SOC paddle. Note that different technologists were involved in the image acquisition. An acceptable tissue coverage for this study refers to having sufficient breast tissue (a balance between fatty and glandular tissue) in the image acquired so that any potential abnormalities can be effectively identified.

Time frame: 1 Day (Day of procedure, No Follow-up)

Population: The number of participants analyzed per group differs from the number provided in the Participant Flow module (429).~Technologists did not provide an answer to the question about preference for tissue coverage in 41 cases. For this reason, the analysis was done in 388 subjects only.~The same 388 subjects are part of both groups: INV and SOC groups. Therefore, the results are shown combined in the data table.

An expert radiologist reviewed, side by side, 3D images acquired with the INV and the SOC paddles in 420 subjects. The radiologist rated the images using a 5-point Likert scale, where -2 and -1 values mean that the images acquired with the SOC paddle have better or slightly better quality, 0 means equal quality between the images, and 2 and 1 mean that the images acquired with the INV paddle have better or slightly better quality than the SOC paddle. To determine overall clinical image quality or image acceptability, the radiologist considered whether the images reviewed have fair lesion visibility (when a lesion is present), good breast tissue separations of structures, good breast tissue coverage, no artifacts due to patient motion, and can be used to determine breast tissue density. Note that not all the 420 images were reviewed by the same radiologist.

Time frame: 1 day (Day of procedure, No Follow-up)

Population: The number of participants analyzed per group differs from the number provided in the Participant Flow module (429).~Data results related to image quality were unclear in nine subjects. For this reason, the analysis considered only 420 subjects.~These 420 subjects are the same in both groups, INV and SOC, so the images can be comparable.~Therefore, the results shown are combined in the data table.