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The intended use of BreGas AB CO2 Clip Indicator is to provide a semi-quantitative visualization of the CO2 in the patient airway or in the gas exhaled from a patient. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.

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This document is a 510(k) clearance letter from the FDA for a device called "CO2 Clip." It primarily states that the device has been found substantially equivalent to a predicate device, allowing it to be marketed. It also includes the Indications for Use.

Crucially, this document does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a more comprehensive premarket submission. The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This means the manufacturer submitted data demonstrating equivalence to an existing device, rather than a de novo clinical study proving novel performance against specific acceptance criteria.

Therefore, I cannot provide the requested information because it is not present in the provided text. To answer your questions, one would need access to the actual 510(k) submission (either the summary or the full submission, if publicly available) which would contain the performance data and the comparison to the predicate device.

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