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For In Vitro Diagnostic Use MetaLite DX Digital Pathology Software is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue for the purposes of pathology primary diagnosis. It is an aid to the pathologist to review, interpret and manage digital images of pathology slides. MetaLite DX Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. MetaLite DX Digital Pathology Software is intended for use with Philips Ultra Fast Scanner and the Barco MDPC-8127 display.

MetaLite DX Digital Pathology Software, Model MLDXUS, version 1.2.1 is software designed for viewing digital pathology images of glass slides from the Philips IntelliSite Pathology Solution Ultra-Fast Scanner (PIPS-UFS), version 1.8.4 on Barco MDPC-8127 display. MetaLite DX Digital Pathology Software is operated as follows: Before scanning the slide on the PIPS-UFS, the technician performs quality control on the tissue of interest. The images captured by the PIPS-UFS are compressed using Philips' proprietary iSyntax format and are transmitted to the Philips Image Management System (IMS). (1) After the Whole Slide Images (WSIs) are successfully, acquired by using PIPS-UFS, the WSIs are stored in the Local file system. A qualified pathologist will upload compatible iSyntax format digital pathology images, and the software will load them to the "Main Viewer" area of the graphical interface for the pathologist to view. (2) Once properly loaded, the pathologist will use the inherent features of the device (including tools that allow for adjusting the position and viewing angle of the image, measuring lengths between two coordinates, and adding annotations to specific regional areas). (3) After viewing all images for a patient (case), the pathologist will make a diagnosis. The diagnosis will be documented in another system, e.g., a Laboratory Information System (LIS). The software has various features such as zoom-in and zoom-out functions, scale display, thumbnail view, measurement function, annotation function, and panning function to help pathologists interpret, diagnose and manage digital whole slide images. The MetaLite DX Digital Pathology Software is validated for use with the components specified the tables below.