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The Teledyne TED 191 oxygen monitor is designed to accurately measure, display, and monitor the actual oxygen concentration present in a defined gaseous environment, either static or dynamic (i.e. either a gas stream or an enclosed body of gas). The device is primarily intended for use in medical applications such as oxygen therapy and ventilatory monitoring, although it may be used in ancillary applications such as checking the purity of compressed air and oxygen, or mixes thereof.

The Teledyne TED 191 oxygen monitor is designed to accurately measure, display, and monitor the actual oxygen concentration present in a defined gaseous environment, either static or dynamic (i.e. either a gas stream or an enclosed body of gas).

This appears to be a 510(k) clearance letter from the FDA for a medical device, the Teledyne TED 191 oxygen monitor. This type of document typically approves a device based on substantial equivalence to a predicate device, but it generally does not contain the detailed study results or acceptance criteria that a manufacturer would have used to demonstrate that equivalence.

Therefore,Based on the provided text, I cannot extract the information requested regarding acceptance criteria and the study that proves the device meets those criteria. The document is an FDA clearance letter, which confirms the device's substantial equivalence to a predicate device, but it does not detail the specific performance studies, acceptance criteria, or ground truth establishment methods used by the manufacturer during their validation process.

The document states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976... A substantially equivalent determination assumes compliance ... with the current Good Manufacturing Practice requirements..."

This indicates that the FDA reviewed the information submitted by the manufacturer, but the full details of the validation studies are not included in this letter.

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