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The BetterCare Platform - Advanced Web Client is a software application capable of displaying physiological data and other patient information to clinicians in near real-time through a web browser. The information is captured from patient monitors by the Draeger Infinity Gateway interfaced with the BetterCare Platform and sent through the hospital local area network to wired or wireless devices running the Advanced Web Client application. The information must be analyzed and interpreted by an expert clinician only. The Better Care Platform is not indicated for use as a real-time monitor.

The BetterCare Platform - Advanced Web Client is intended to display data and waveforms from attached medical devices in a pass-though fashion, the BetterCare Platform - Advanced Web Client is agnostic to the age or condition of patients attached to the medical devices from which data is received. For example, the special requirements for neonatal, pediatric or adult patients are all provided by the medical devices directly attached to the patient. The BetterCare Platform - Advanced Web Client simply reproduces that numeric, waveform and other clinical data provided to it for communications and display.

The Better Care Platform - Advanced Web Client is installed on compatible desktop and mobile devices including cellular telephones, and is intended to be used by clinicians to:

• remotely view patient physiological information as captured by Draeger Infinity Gateway
• remotely view waveforms as captured by Draeger Infinity Gateway
• remotely view other patient data as captured by Draeger Infinity Gateway

The BetterCare Platform - Advanced Web Client is not patient connected and is not a primary alarm source. It can display the following physiological data captured by Draeger Infinity Gateway:

• ECG Waveform
• Arterial Pressure Waveform
• SpO2 Waveform
• CO2 Waveform
• Central Venous Pressure Waveform
• Pulmonary Arterial Pressure Waveform
• Right Auricular Pressure Waveform
• Left Auricualar Pressure Waveform
• Resp Waveform
• Heart Rate
• Respiratory Rate
• Oxygen Saturation
• Central Venous Pressure
• Systolic Arterial Pressure Invasive
• Mean Arterial Pressure Invasive
• Diastolic Arterial Pressure Invasive
• Systolic Blood Pressure Non invasive
• Mean Bloood Pressure Non invasive
• Diastolic Blood Pressure Non invasive
• Systolic Pulmonary Arterial Pressure
• Mean Pulmonary Arterial Pressure
• Diastolic Pulmonary Arterial Pressure
• Right Auricular Pressure
• Left Auricular Pressure

BetterCare Platform Advanced Web Client is intended to be installed on wired and wireless devices. including cellular telephones, and is not intended to be used where such devices are prohibited.

BetterCare Platform Advanced Web Client is intended for use by trained clinicians in hospital environments as a diagnostic aid and not as a replacement for direct viewing of any of the monitoring devices interfaced.

The BetterCare Platform - Advanced Web Client is a software application capable of displaying physiological data and other patient information to clinicians in near real-time through a web browser. The information is captured by Draeger Infinity Gateway interfaced with the BetterCare Platform and sent through the hospital local area network to wireless devices running the Advanced Web Client application. The information must be analyzed and interpreted by an expert clinician only.

I am sorry, but the provided text does not contain the acceptance criteria and study details you requested for the "BetterCare Platform - Advanced Web Client" device. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria.

Here's what the document does provide, and why it doesn't fulfill your request:

• Intended Use and Indications for Use: These describe what the device is for and how it should be used, but not specific performance metrics.
• Comparison to Predicate Devices: It outlines the similarities and differences in features and functionality, which is the basis for the substantial equivalence claim.
• Non-Clinical Data Summary: This section mentions design, development, testing, verification, and validation according to documented procedures and FDA guidance documents (ISO 14971, ISO 62304). It states: "Testing included verification of all available listed waveform and near real-time data points. Known data sets were gathered using Draeger Infinity Gateway interfaced with BetterCare Platform and displayed on Advanced Web Client. All waveforms and near-real time physiological information points were verified and in all cases, Advanced Web Client displayed data points accurately."
• Clinical Data Summary: Explicitly states: "No clinical data is submitted to support this premarket notification."

Therefore, I cannot provide the requested information because it is not present in the given text.

To answer your questions, I would need a different type of document, such as a detailed test report, verification and validation plan, or a more comprehensive study summary that includes specific acceptance criteria and the results of performance studies.

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