(154 days)
Siemens FiO2 sensor is indicated for use in an environment where patient care is provided by healthcare professionals, i.e. Physicians, Nurses, Technicians, when the professional determines that the device is required to monitor the oxygen level of ambient air in non-pressurized environments such as that found in infant incubators and oxygen hoods.
The FiO2 Sensor is an addition to the Siemens INFINITY patient monitoring series that measures the oxygen concentration of ambient air in non-pressurized environments such as that found in infant incubators and oxygen hoods. In conjunction with the INFINITY NeoMed pod, the FiO2 Sensor permits oxygen concentration monitoring to be displayed on the INFINITY modular bedside monitors, MultiView WorkStations, and PC's via the INFINITY network.
I am sorry, but the provided text does not contain a study with acceptance criteria and reported device performance for the Siemens FiO2 Sensor.
The document is a 510(k) premarket notification summary, which primarily focuses on demonstrating substantial equivalence to a predicate device. While it lists some device specifications, it does not describe a comprehensive study with specific acceptance criteria, experimental design, or detailed performance results that would allow me to fill in all the requested information.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy |
§ 868.1720 Oxygen gas analyzer.
(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).