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INFINITT ULite, PACS is a software device that receives medical images and data from various images. Images and data can be stored, communicated, processed, and displayed within the system or across computer networks at distributed locations. Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary inage interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, and medical technicians.

The INFINITT ULIte™ system is PACS software capable of viewing and handling DICOM 3.1 medical images. The System allows displaying studies that are not in the same place where the system is placed. With its Web features, it is possible to review, modify, and approve studies located in a server.

ULite is a device that displays medical images (including mammograms) and data from various imaging sources. In the Web environments, it is not needed to download any components, for example Active X, flash, flex, sliver lite, and the user can use this viewer in the browser. Typical users of this system are professionals of clinic (e.g. physicians, radiologists, nurses, medical technicians, and assistants).

INFINITT ULite (subject device) is based upon the INFINITT G3 PACS (predicate device). The features and functions of ULite have a sub-set of the features and functions of G3 PACS with an updated operating system due to current advances in computer technology.

INFINITT ULite Viewer: INFINITT ULIte is a medical image viewing application. It communicates with the INFINITT ULite Server to view the medical images. It supports various functions such as Windowing, Zoom, Pan, measurement, Cine play, and Report viewing.

INFINITT ULite Server: INFINITT ULite Server only supports Microsoft Windows family. INFINITT ULite Server has been built by using Microsoft Visual C++ 2010, MFC library and .net framework.

ULite software provides both 32-bit and 64-bit editions. When running on x64 editions of Microsoft Windows, the native x64-bit application of ULite must be provided for largememory support. The 32-bit application of ULite can be running on both 32bit and 64bit windows, while the maximum memory capacity might be different. Except the maximum memory support, the 32-bit edition and 64-bit edition must be virtually same in terms of functionalities.

The provided text is a 510(k) summary for the INFINITT ULite PACS software. It describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics, or a study proving that the device meets specific performance criteria.

The "Testing" section on page 4 briefly states: "The complete system configuration has been tested at the factory and the device has passed all in-house pre-determined testing criteria without significant failures. The data presented in the submission demonstrates that INFINITT ULite™ performs all required actions according to the functional requirements specified in the Software Requirements Specification and the User Manual with no errors that had an impact on safety or efficacy."

This statement is high-level and generic. It does not provide the specific details requested in the prompt, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance for a test set.
• Details about ground truth establishment (number/qualifications of experts, adjudication method, type of ground truth).
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Details about the training set.

Therefore, based solely on the provided text, I cannot complete the requested tables and information. The document focuses on regulatory submission for substantial equivalence rather than detailed performance study results.

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