(359 days)
The TED 200T7 is intended to continuously measure and display the concentration of oxygen in gas mixtures used in medical applications such as anesthesia, respiratory therapy, and is intended for adult, pediatric and neonatal populations.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "Ted 200T7 Oxygen Monitor." This document primarily deals with regulatory clearance and establishes substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria, nor does it detail a clinical performance study with human subjects or AI components.
Therefore, I cannot provide the requested information from this document. The document confirms the device is substantially equivalent to legally marketed predicate devices, which is a regulatory hurdle, not a detailed performance study as you've described for AI/ML devices.
To answer your prompt, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report that details the device's performance, acceptance criteria, and the methodology of a specific study.
§ 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).