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ProstatID™ is a radiological computer assisted detection (CADe) and diagnostic (CADx) software device for use in a healthcare facility or hospital to assist trained radiologists in the detection, assessment and characterization of prostate abnormalities, including cancer lesions using MR image data with the following indications for use. ProstatID analyzes T2W, DWI and ADC MRI data. ProstatID does not include DCE images in its analysis. ProstatID software is intended for use as a concurrent reading aid for physicians interpreting prostate MRI exams of patients presented for high-risk screening or diagnostic imaging, from compatible MRI systems, to identify regions suspicious for prostate cancer and assess their likelihood of malignancy. Outputs of the device include the volume of the prostate and locations, as well as the extent of suspect lesions, with index scores indicating the likelihood that cancer is present, as well as an exam score by way of PI-RADS interpretation suggestion. "Extent of suspect lesions" refers to both the assessment of the boundary of a particular abnormality, as well as identification of multiple abnormalities. In cases where multiple are present, ProstatID can be used to assess each abnormality independently. Outputs of this device should be interpreted with all available MR data consistent with ACR clinical recommendations (e.g., dynamic contract enhanced if available) in context of PI-RADs v2, and in conjunction with bi-parametric MRI acquired with either surface or endorectal MRI accessory coils from compatible MRI systems. Analysis by ProstatID is not intended as a replacement for interpreting prostate abnormalities using MR image data consistent with clinical recommendations (including DCE); nor should patient management decisions be made solely on the basis of ProstatlD.

ProstatID™ is a radiological computer assisted detection (CADe) and diagnostic (CADx) softwareonly device for use in a healthcare facility or hospital to assist trained radiologists in the detection, assessment, and characterization of lesions suspicious for cancer using MR image data. ProstatID is intended for use as a concurrent reading aid for physicians interpreting prostate MRI exams of patients presented for high-risk screening or diagnostic imaging, from compatible MRI systems. Deep learning and Random Forest algorithms are applied to the DICOM image set of MRI Axial Images (T2W, DWI, and ADC) of the prostate for recognition of the prostate gland, its central gland, and recognition and classifying the likelihood of malignancy of any suspicious lesions. Algorithms are trained with a large database of biopsy-proven examples of normal, benign, and cancerous tissues. The software is not installed on the user's MRI system, workstation, or any device other than the cloud-based servers configured as a Software as a Service (SaaS) model. ProstatID offers the following functions which may be used during the concurrent interpretation: - 1. Computer aided detection (CAD) presented as a colorized translucent overlay of the 2D axial T2 images to highlight locations where the device detected suspicious soft tissue lesions. - 2. An appended post-processed T2W image set that can be viewed concurrently and linked three dimensionally via standard DICOM viewing with the original image set. - Decision Support is provided by the regional overlay scores on a continuous scale 3. ranging from 0-1 with the higher scores indicating a higher level of suspicion (LOS). - A suggested LOS or overall PI-RADS exam score. 4. - 5. A CAD created 3D rendition of the suspect cancerous tissue within the transparent 3D prostate gland. - 6. A .PDF report summarizing the software results with 2D and 3D images indicating suspect cancerous regions if detected. Results of ProstatID are computed in a processing server which accepts prostate MRI exams in DICOM format as input, identifies the required axial image sets and processes them, deletes all others, and sends the output to append to the unique patient study destination using the DICOM protocol and format for post-processed images and reports. Use of the device is supported for images from the following MRI systems: Philips 1.5T, GE 3.0T, Philips 3.0T and Siemens 3.0T. Common destinations are medical workstations, PACS and RIS that utilize DICOM image transfer. ProstatID is offered as a virtual or SaaS application and runs on dedicated servers. Implementation requires secure VPN connection between client and SaaS server.