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Infinitt PACS 7.0,"is a software device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, 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 image 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.

Infinitt PACS 7.0™ device is PACS software capable of viewing and handling DICOM 3.x medical images. The System allows displaying of images and image studies that may not in the location as the modality. With its Web features, it is possible to review, modify, and approve studies located in a remote server.

INFINITT PACS is a software device that does not contact the patient, nor does it control any life sustaining devices. The software does not provide any diagnostic assistance to the physician. Any diagnostic determination or treatment is solely determined by a physician and not the software. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed.

Infinitt PACS 7.0 is a web-based, 3D-enabled DICOM view station running on Windows 7/8.1/10. Infinitt PACS 7.0 is an integral component of INFINITT's complete INFINITT PACS/RIS solution. Infinitt PACS 7.0 fully supports DICOM standards and such functions as advanced DICOM viewing, Hanging Protocol, various 3D display such as MPR, Volume Rendering, MIP and fusion. Infinitt PACS 7.0 allows users to take full advantage of the radiographic images from various modalities in order to obtain invaluable mission critical diagnostic data and images.

With Infinitt PACS 7.0, users can access their own diagnostic environment anywhere, anytime. This is made possible because Infinitt PACS 7.0 is deployed through a network and supports hanging protocol. Also, Infinitt PACS 7.0 uses JPEG 2000 features so that it takes less time to transfer images through a network.

Infinitt PACS 7.0 is based upon the INFINITT G3 PACS (predicate device). The features and functions of Infinitt PACS 7.0 have similar features and functions of G3 PACS with an updated operating system due to current advances in computer technology.

The provided text is a 510(k) Summary for Infinitt PACS 7.0. It describes the device, its intended use, and compares it to a predicate device (INFINITT G3 PACS). However, it does not contain information about a study that describes specific acceptance criteria and detailed device performance metrics (such as sensitivity, specificity, accuracy), sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies for an AI-powered device.

The document states:

• "The software does not provide any diagnostic assistance to the physician." (Page 4)
• "A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed." (Page 4)

This indicates that Infinitt PACS 7.0 is a Picture Archiving and Communication System (PACS) and an image processing system, not an AI/CAD (Computer-Aided Detection/Diagnosis) device. As such, the type of performance studies, acceptance criteria, and ground truth establishment typically associated with AI devices (as requested in the prompt) are not applicable or detailed in this 510(k) summary.

The "Testing" section broadly states that the device "passed all in-house pre-determined testing criteria without significant failures" and "performs as required 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 refers to functional and system testing, not diagnostic performance testing against specific clinical endpoints or ground truth, as would be expected for an AI/CAD device.

Therefore, I cannot extract the requested information (performance metrics, sample sizes, expert qualifications, MRMC studies, etc.) from the provided text because it describes a PACS system without an AI diagnostic assistance component.

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