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Siemens MultiView WorkStation, INFINITY Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Siemens Patient Monitoring Systems and recorders.

The Infinity Gateway Suite software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.

The Infinity Gateway Suite (K014213) is a server-based software application that provides a connection to the Infinity Network (K955059) and the hospital network infrastructure for the data exchange of select clinical and administrative information. The Infinity Gateway complies with healthcare information protocols to support data sets of many different sources, including medical devices, hospital information systems, clinical information systems, and laboratory systems.

Infinity Gateway includes a suite of software products to support the unique needs of hospitals, and provide a complete range of options for information connectivity:

• Server Software
• Interface Software Options
• Developers Tools ●
• Remote View Applications
• Pager Interface .

The primary modification included in the VF2 software release of the INFINITY Gateway Suite is the option for the Infinity Gateway Pager Interface. The pager interface transmits select alphanumeric monitor alarm data to paging service providers that support the Telocator Alphanumeric (TAP) Protocol, Revision 1.7 and European Standard Paging Application (ESPA) Protocol. Revision 4.4.4

This document is a 510(k) summary for the INFINITY Gateway Suite, VF2. It focuses on regulatory approval and does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information from the given text. The document primarily describes the device, its intended use, and its classification, concluding with an FDA approval letter based on substantial equivalence to a predicate device. It lacks specific performance metrics that would typically be found in a study summary.

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Siemens MultiView WorkStation, INFINITY Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Siemens Patient Monitoring Systems and recorders.

The Infinity Gateway Suite software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.

The Infinity Gateway Suite is a server-based software application that provides a connection to the Infinity Network (K955059) and the hospital network infrastructure for the data exchange of select clinical and administrative information. The Infinity Gateway complies with healthcare information protocols to support data sets of many different sources, including medical devices, hospital information systems, clinical information systems, and laboratory systems.

Infinity Gateway includes a suite of software products to support the unique needs of hospitals, and provide a complete range of options for information connectivity:

• Server Software 1
• . Interface Software Options
• Developers Tools 내
• Remote View Applications B

I am sorry; this document does not contain the information requested. This document is a 510(k) summary for the INFINITY Gateway Suite, a software application, and as such, it does not include details on acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The document primarily focuses on the device description, intended use, and its substantial equivalence to a predicate device.

Ask a specific question about this device