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TRAQinform IQ is a software only device that provides a quantitative TRAQinform Report on lesions identified as Regions of Interest (ROI) in PET/CT DICOM compliant imaging data acquired, interpreted, and reported on per local practice prior to device use. Clinicians responsible for patient care and for ordering TRAQinform Reports as an adjunct to locally reported image interpretation do not interact directly with the device. Clinicians responsible for local image interpretation do not interact with the device and generate their reporting before and independently of the TRAQinform Report. The TRAQinform Report is generated by the device manufacturer and signed by a U.S. board certified physician responsible for supervising central report generation and qualified to practice nuclear radiology/medicine. The TRAQinform Report is for use by trained medical professionals including but not limited to oncologists, nuclear radiologists/physicians, medical imaging technologists, dosimetrists, and physicists. TRAQinform IQ software contains the following functionalities: - Automated matching of ROI between previously performed CT and PET/CT DICOM 3.0 volumetric medical images. - In order to perform automated matching of ROI and quantitative analysis of previously performed CT and PET/CT DICOM 3.0 volumetric medical images, the software initially performs the following functions: - Machine learning skeletal and anatomic structure segmentation. - Threshold-based ROI identification and contouring. - Automated quantitative analysis to assess previously performed CT and PET/CT DICOM 3.0 volumetric medical images, including: change in total volume and density of each identified ROI, and change in Fludeoxyglucose F18 (FDG) tracer uptake of each identified ROI among images. - Generation of images of the anatomy combined with spatial and quantitative information, including computed classification of quantitative FDG ROI changes. For multi-timepoint quantitative analysis, recommended use is in adult patients 22 years and older with partial or whole-body PET/CT acquired following administration of FDG per approved drug prescribing information and with the second FDG administration separated from the first by a period not to exceed 12 months. For single-timepoint quantitative analysis, recommended use is in adult patients 22 years and older with partial or whole-body PET/CT following administration of FDG, a PSMA targeted PET drug, or a SSTR-targeted PET drug per approved drug prescribing information. Discrepancies between TRAQinform IQ and local PET/CT reporting have been investigated and use of TRAQinform IQ has not been established for binary patient level progression or non-progression decisions without multidisciplinary review. Discrepancies between TRAQinform IQ and local PET/CT reporting that could impact patient care should therefore prompt consultation with subject matter experts (for example, in tumor board), with a patientcentered focus on discrepant imaging regions and with blinded or otherwise neutral adjudication regarding interpretation/classification source. TRAQinform IQ is not intended to diagnose any disease, replace the diagnostic procedures for interpretation of CT or PET/CT images, recommend any specific treatment, nor is it intended to replace the skill and judgment of a qualified medical professional.

TRAQinform IQ is a software only device that provides quantitative analysis of lesions identified as Regions of Interest (ROI) in PET/CT DICOM compliant imaging data acquired, interpreted, and reported on per local practice prior to device use. The input to TRAQinform IQ is CT and PET/CT images as supported by ACR/NEMA DICOM 3.0. The following steps are performed by the software: - Automatic threshold-based ROI segmentation: - ROI can also be imported from external sources (other validated tools or manual contouring by qualified medical personnel). - Automatic ROI registration between multiple images: - Images can be from the same or different imaging modality. - Images can be from the same or different PET tracer. - Images can be from the same or different date. - Automatic matching of ROI between multiple, previously performed images. - Automatic quantification of dynamic changes among images including, but not limited to: - Changes in ROI shape. - Single ROI splitting into multiple ROI. - Multiple ROI combining into a single ROI. - ROI appearing, disappearing, and re-appearing across images. - A comprehensive summary analysis. TRAQinform IQ calculates spatial and quantitative metrics for each individual ROI. These metrics are provided as a TRAQinform Report. TRAQinform IQ uses computational algorithms to detect, fuse and analyze ROI and provides the following outputs: - Identification of anatomic location of ROI in all areas of the body. - A quantitative analysis of functional and anatomic data for CT and PET/CT scans, including: - Volume of all identified ROI on each image; - Change in volume of each identified ROI among images: - Total volume of all identified ROI on each image; - Change in total volume of all identified ROI on each image; - Heterogeneity of change in volume of each identified ROI: - For PET scans: - Tracer uptake (SUVmax, SUVtotal, SUVmean, SUVhetero) of each identified ROI on each image: - Change in tracer uptake (SUVmax, SUVtotal, SUVmean) of each identified ROI among images: - Total tracer uptake (SUVmax, SUVtotal, SUVmean, SUVhetero) of all identified ROI on each image: - Change in total tracer uptake (SUVmax, SUVtotal, SUVmean, SUVhetero) of all identified ROI on each image: - Heterogeneity of change in tracer uptake (SUVhetero) among identified ROI. - For CT scans - Radio density (HUmax, HUtotal, HUmean, HUhetero) for each identified ROI on each image: - Changes in radio density (HUmax. HUtotal. HUmean) of all identified ROI on each image: - Change in total radio density (HUmax, HUtotal, HUmean, HUhetero) of all identified ROI on each image; - Heterogeneity of change in radio density (HUhetero) among identified ROI. - 2D graphical renderings of medical images, including Maximum Intensity Projections of the PET and CT, with overlayed and labeled/color-coded ROI, for inclusion in TRAQinform Reports. - 3D labeled contours for ROI, anatomic structures, and skeletal structures. The TRAQinform IQ software operates in a secure cloud environment.