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The STELLAR 404 two parameter Patient Monitoring System is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during hospital transport along with the appropriate accessories mentioned/ supplied with the unit. Vital signs parameter includes Plethysmograph. It can also display the digital values of PR, SpO2 Non-Invasive Blood Pressure (Systolic, Diastolic and Mean) readings.

The user, responsible to interpret the monitored data made available, will be a professional health-care provider. The device, which can also be used as a portable device, permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.

This STELLAR 404 unit is a 2 parameter Patient monitor System (TFT color monitor) with NIBP and Pulse oximetry with an optional inbuilt two channel thermal array recorder for printing of Tabular trends & waveforms.

STELLAR 404 has waveform display capability for Plethysmograph. It also displays the digital values of PR, SpO2 and Non-Invasive Blood Pressure (Cystolic, Diastolic and Mean) readings. It has graded and color coded alarms It has 2 hours and 12 hours tabular and graphical trends for SpO2. It has special tabular trend for NIBP to store the last 100 readings. Alarm recall feature offers last 16 alarm conditions.

The provided document is a 510(k) summary for the STELLAR 404 Patient Monitoring System. It explicitly states that the device's technological characteristics, range and accuracy of parameters, and method of sensing are similar to the predicate device, PLANET patient Monitoring System (K032871). The conclusion is based on this similarity, asserting substantial equivalence without posing additional risk to safety or effectiveness.

However, the 510(k) summary does not contain information about specific acceptance criteria, a study proving the device meets these criteria, or detailed performance metrics from such a study.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the provided text. Similarly, I cannot extract information about sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established, as these details are not present in the document.

The document primarily focuses on establishing substantial equivalence to a predicate device through comparison of features and compliance with general safety standards (IEC 60601-1 and IEC 60601-1-2).

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