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CO2 Monitoring Lines are intended to connect from a CO2 sampling port to the expired gas monitor.

The Besmed CO2 monitoring line with and without in-line filter is single use, small diameter tubing intended to be connected to a port on a face mask or breathing circuit to allow for gas sampling from a patient's breath by gas sampling equipment. The gas monitoring device will have a pump, which pulls air from inside mask through the monitoring line and into the gas sampling equipment. The monitoring line is available with or without a hydrophobic filter, which prevents the transfer of water down the monitoring line and into the gas sampling equipment. Lines are available with male/male or male/female luer connections. The patient connectors incorporate a midstream gas sampling port and are made of clear rigid plastic.

The provided text describes a 510(k) premarket notification for a medical device called "Besmed CO2 Monitoring Line With and Without In-Line Filter." This document does not pertain to an Artificial Intelligence (AI) device, but rather a passive medical accessory. As such, many of the requested categories related to AI device evaluation (such as sample size for test sets and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training data) are not applicable or a study as described would not have been performed.

However, I can extract the acceptance criteria and performance data provided for this specific device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by comparing the proposed device's performance to that of a legally marketed predicate device (K122075 – Intersurgical – CO2 Monitoring Line). The goal is to demonstrate "equivalent performance."

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