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The Infinity Delta and Kappa series modular monitors are intended for multiparameter patient monitoring. The devices will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. These devices will connect to an R50 Bedside recorder, either directly or via the Infinity Network.

The INFINITY Modular monitors are capable of monitoring:

• Heart rate .
• . Respiration rate
• Invasive pressure .
• Non-invasive pressure .
• Arrhythmia .
• . Temperature
• Cardiac output .
• . Arterial oxygen saturation
• . Pulse rate
• Apnea
• . ST Segment Analysis
• 12-Lead ST Segment Analysis .
• tcp02/tcpC02 .
• EEG signals .
• t FiO2

SCIO gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, halothane, isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the Infinity monitors.

With etCO2 the monitors can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored.

The monitors can interface with specific third party devices via an MIB protocol converter.

The intent of this 510(k) is to describe software modifications for the Infinity Delta and Kappa series modular monitors (Delta, Delta XL, Kappa, Vista XL, Gamma X XL, SC7000, SC8000, SC9000XL), including MIB modifications.

The provided text is a 510(k) premarket notification for software modifications to existing physiological patient monitors. It does not contain information about acceptance criteria or specific studies to prove device performance against such criteria. The document focuses on establishing substantial equivalence to previously cleared devices based on verification and validation testing, but the details of this testing, including acceptance criteria, sample sizes, ground truth establishment, or expert involvement, are not provided.

Therefore, I cannot extract the requested information.

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