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The Unity® IS Patient Viewer is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the Unity® IS Patient Viewer is to provide a remote view of physiological parameter data on adult, pediatric and neonatal patients within a hospital or facility providing patient care. The Unity® IS Patient Viewer is NOT intended for primary monitoring but is to be used in conjunction with the bedside monitor. The Unity® IS Patient Viewer is intended to provide near-real-time physiological data and graphical trends for all monitors connected to the Unity Network to secure nurse and physician personal computers (local and remote).

The Unity® IS Patient Viewer provides remote access to waveform, parameter data and trend data at a web browser on a standard personal computer. The server resides on the hospital's intranet and remote access is gained through secured access to the hospital intranet. The data relayed from the patient monitors over the Unity® MC network includes patient name, unit and bed name, parameter data, and waveform data monitored by the bedside monitors. The user can view up to nine waveforms from the Unity® MC network as well as the parameter information in near real-time. Neither alarm messages nor parameter status messages are displayed. The Unity® IS Patient Viewer system provides a secondary view of patient information, and is NOT a patient monitoring device. The clinician is instructed to always reference the primary bedside monitor before making any patient care decisions. In the event that data is not available via the Unity® IS Patient Viewer, the clinician is instructed to obtain the data from the primary bedside monitor. The Unity® IS Patient Viewer system consists of a 1U Rack Mountable Server with server and client software packages. The two software pieces reside on the 1U Rack Mountable Server, which is a standard hardware server platform for hosting network applications. The hardware server is connected to two networks: Unity® Network and the hospital's Intranet. The Unity® Network is a currently marketed proprietary network connecting patient monitors. The hospital's Intranet refers to the existing Local Area Network (LAN) within the hospital that connects a number of personal computers (PCs).

The provided text describes the Unity® IS Patient Viewer, a device intended for remote viewing of physiological data. However, the document does not include specific acceptance criteria or a detailed study report that proves the device meets such criteria.

The "Test Summary" section in {1} lists various quality assurance measures applied during development, such as:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Final acceptance testing (Validation)
• Performance testing
• Safety testing
• Environmental testing

It concludes that "The results of these measurements demonstrated that the Unity® IS Patient Viewer are as safe, as effective, and perform as well as the predicate device." However, no quantitative acceptance criteria or the reported device performance against those criteria are provided.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I answer points 2 through 9, as the necessary information is not present in the provided text. The document is a 510(k) summary, which typically provides a high-level overview rather than detailed study results.

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