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TRIP Tonometry Catheter, 14F is used for the determination of regional PCO2 (PrCO2) and intramucosal pH (pHi) of the gastric mucosal tissue when used as a gastrointestinal tract access device for connecting a Tonocap™ monitor (Regional and Airway capnometer) . The sampling line and biofilter built into the device serve as a means of connecting the catheter to the monitor and as transducer protector to prevent patient cross-contamination and monitor damage, respectively. It incorporates a second lumen used for feeding and/or decompression or aspiration of the contents of the stomach.

It is indicated for use in surgical/operating room patients, intensive care unit patients , emergency/trauma patients and hospital patients with suspected mesenteric ischemia.

TRIP Tonometry Catheter, 14F is used for the determination of regional PCO2 (PrCO2) and intramucosal pH (pHi) of the gastric mucosal tissue when used as a gastrointestinal tract access device for connecting a Tonocap™ monitor (Regional and Airway capnometer) . The sampling line and biofilter built into the device serve as a means of connecting the catheter to the monitor and as transducer protector to prevent patient cross-contamination and monitor damage, respectively. It incorporates a second lumen used for feeding and/or decompression or aspiration of the contents of the stomach.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.

The document is a 510(k) clearance letter from the FDA for a "TRIP Tonometry Catheter, 14F". It indicates that the device has been found substantially equivalent to predicate devices, allowing it to be marketed. However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test or training sets.
• Information on data provenance (country of origin, retrospective/prospective).
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results of a standalone (algorithm only) performance study.
• The type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for a training set was established.

This document is a regulatory approval, not a scientific study report or a summary of performance data.

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