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Koios Decision Support (DS) is an artificial intelligence (AI)/machine learning (ML)-based computer-aided diagnosis (CADx) software device intended for use as an adjunct to diagnostic ultrasound examinations of lesions or nodules suspicious for breast or thyroid cancer. Koios DS allows the user to select or confirm regions of interest (ROIs) within an image representing a single lesion or nodule to be analyzed. The software then automatically characterizes the selected image data to generate an AI/ML-derived cancer risk assessment and selects applicable lexicon-based descriptors designed to improve overall diagnostic accuracy as well as reduce interpreting physician variability. Koios DS software may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report. Koios DS software is designed to assist trained interpreting physicians in analyzing the breast ultrasound images of adult (>= 22 years) female patients with soft tissue breast lesions and/or thyroid ultrasounds of all adult (>= 22 years) patients with thyroid nodules suspicious for cancer. When utilized by an interpreting physician who has completed the prescribed training, this device provides information that may be useful in recommending appropriate clinical management. Limitations: · Patient management decisions should not be made solely on the results of the Koios DS analysis. · Koios DS software is not to be used for the evaluation of normal tissue, on sites of post-surgical excision, or images with doppler, elastography, or other overlays present in them. · Koios DS software is not intended for use on portable handheld devices (e.g. smartphones or tablets) or as a primary diagnostic viewer of mammography images. · The software does not predict the presence of the thyroid nodule margin descriptor, extra-thyroidal extension. In the event that this condition is present, the user may select this category manually from the margin descriptor list.

Koios Decision Support (DS) is a software application designed to assist trained interpreting physicians in analyzing breast and thyroid ultrasound images. The software device is a web application that is deployed to a Microsoft IIS web server and accessed by a user through a compatible client. Once logged in and granted access to the Koios DS application, the user examines selected breast or thyroid ultrasound DICOM images. The user selects Regions of Interest (ROIs) of orthogonal views of a breast lesion or thyroid nodule for processing by Koios DS. The ROI(s) are transmitted electronically to the Koios DS server for image processing and the results are returned to the user for review.

Koios DS is an artificial intelligence (Al)/machine learning (ML)-based computer-aided diagnosis (CADx) software device intended for use as an adjunct to diagnostic ultrasound examinations of lesions or nodules suspicious for breast or thyroid cancer. Koios DS allows the user to select or confirm regions of interest (ROIs) within an image representing a single lesion or nodule to be analyzed. The software then automatically characterizes the selected image data to generate an AI/ML-derived cancer risk assessment and selects applicable lexicon-based descriptors designed to improve overall diagnostic accuracy as well as reduce interpreting physician variability. Koios DS may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report. Koios DS software is designed to assist trained interpreting physicians in analyzing the breast ultrasound images of adult (>= 22 years) female patients with soft tissue breast lesions and/or thyroid ultrasounds of all adult (>= 22 years) patients with thyroid nodules suspicious for cancer. When utilized by an interpreting physician who has completed the prescribed training, this device provides information that may be useful in recommending appropriate clinical management. Limitations: · Patient management decisions should not be made solely on the results of the Koios DS analysis. · Koios DS software is not to be used for the evaluation of normal tissue, on sites of post-surgical excision, or images with doppler, elastography, or other overlays present in them. · Koios DS software is not intended for use on portable handheld devices (e.g. smartphones or tablets) or as a primary diagnostic viewer of mammography images. • The software does not predict the thyroid nodule margin descriptor, extra-thyroidal extension. In the event that this condition is present, the user may select this category manually from the margin descriptor list.

Koios DS is a software application designed to assist trained interpreting physicians in analyzing breast and thyroid ultrasound images. The software device is a web application that is deployed to a Microsoft IIS web server and accessed by a user through a compatible client. Once logged in and granted access to the Koios DS application, the user examines selected breast or thyroid ultrasound DICOM images. The user selects Regions of Interest (ROls) of orthogonal views of a breast lesion or thyroid nodule for processing by Koios DS. The ROI(s) are transmitted electronically to the Koios DS server for image processing and the results are returned to the user for review.

Koios Decision Support (DS) for Breast is a software application designed to assist trained interpreting physicians in analyzing the breast ultrasound images of patients with soft tissue breast lesions who are being referred for further diagnostic ultrasound examination. Koios DS for Breast is a machine learning-based decision support system, indicated as an adjunct to diagnostic ultrasound for breast cancer. Koios DS for Breast automatically classifies user-selected region(s) of interest (ROIs) containing a breast lesion into four BI-RADS-aligned categories (Benign, Suspicious, Probably Malignant), and displays a continuous graphical confidence level indicator of where the lesson falls across all categories. Koios DS for Breast also automatically classifies lesion shape and orientation according to BI-RADS descriptors. The software requires a user to select up to two orthogonal views, that represent a single lesion to be selected and processed. When utilized by an interpreting physician who has completed training, this device provides information that may be useful in rendering an accurate diagnosis. Patient management decisions should not be made solely on the results of the Koios DS for Breast analysis. This device is intended to help trained interpreting physicians improve their overall accuracy as well as reduce inter- and intra-operator variability. Koios DS for Breast may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report. Limitations: Koios DS for Breast is not to be used on sites of post-surgical excision, or images with doppler, elastography, or other overlays present in them. Koios DS for Breast is not intended for the primary interpretation of digital mammography images. Koios DS for Breast is not intended for use on mobile devices.

Koios Decision Support (DS) for Breast is a software application designed to assist trained interpreting physicians in analyzing breast ultrasound images. The system provides image derived data via web triggering and remote analysis. The software device is a web application that is deployed to a Microsoft IIS web server and accessed by a user through a compatible client. Once logged in and granted access to the Koios DS for Breast application, the user examines selected breast ultrasound DICOM images. The user selects up to two Regions of Interest (ROIs) of two orthogonal views of a breast lesion for processing by Koios DS for Breast. The ROI(s) are transmitted electronically to the Koios DS for Breast server for image processing and the results are returned to the user for review. The Koios DS for Breast core engine characterizes image features using the ROI data to generate a categorical output that aligns to BI-RADS categories. The engine uses computer vision and machine learning techniques embedded within a software capable of reading, interpreting, analyzing, and generating findings from ultrasound data. The underlying engine draws upon knowledge learned from a large database of known cases, tying image features to their eventual diagnosis, to form a predictive model. The categorical output of the Koios DS for Breast engine is divided into four categories (Benign, Probably Benign, Suspicious, Probably Malignant), separated by three operating points, aligning with or exceeding the sensitivity and specificity of radiologist chosen BI-RADS categorizations. . The output of the system is a digital display to be used as a concurrent read. Koios DS for Breast is intended to support compliance with the ACR BI-RADS ultrasound lexicon classification form. The engine additionally classifies the region of interest on the basis of shape (Oval, Round, Irregular) and orientation (Parallel to Skin, Not Parallel). Koios DS for Breast results can be saved or transferred in three separate ways: in-transit transmission, PACS saving, and exporting results to third-party reporting software. Intransit transmission may be utilized when users wish to share analyses across viewing workstations. Results can be stored in in-transit memory for a preset period of time defined by a system administrator. These results are never locally cached, written to disk, or otherwise stored outside of in-transit memory. After that preset period of time, all results are wiped from the local memory. Another method of saving is storing a report in the patient series on the PACS. After single or multiple breast lesion analyses have been performed and ultimately accepted by a trained interpreting physician, Koios DS for Breast can export a summary report to PACS as an addendum to the DICOM series that was selected for processing. This report serves as future reference and aid in comparison of cases requiring follow up. This functionality is strictly reserved for approved users. Koios DS for Breast also supports exporting results to third-party reporting software to facilitate the reporting process. Saving or exporting preferences can be configured by the system administrator and user. The Koios DS for Breast software is an ASP.NET web application that is deployed to an IIS Web Server inside a Windows operating system environment. The software does not require any specialized hardware, but the time to process ROIs will vary depending on the hardware specifications. If utilizing the recommended technical specifications, the time to generate and present results for two analyzed ROIs will be <= 2 seconds. The Koios DS for Breast processing software is a platform agnostic web service that queries and accepts DICOM compliant digital medical files from any DICOM compliant device. Koios DS for Breast is intended to be used on patients with soft tissue breast lesions who are being referred for further diagnostic ultrasound examination.