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The Endoscopic Clean Connecting Tubes includes five subsets as below, they are intended to o provide sterile water and/ or CO2 and/ or air to an endoscope during gastrointestinal endoscopic procedure. These devices are intended to be used by healthcare professional only. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. It is supplied in sterile.

The Endoscopic CO2 Source Tubing is intended to be used with a CO2 insufflator along with Clean Cap or Hybrid Irrigation Tubing to supply CO2 to a GI endoscope during GI endoscopic procedures.

The proposed device includes two (2) categories:

• Endoscopic Clean Connecting Tubes
• Endoscopic CO2 Source Tubing

The proposed device, Endoscopic Clean Connecting Tubes, is to connect an air/ CO2 source, a sterile water source (water bottle), and an endoscope to supply air/ CO2 and water during gastrointestinal endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. It is supplied in sterile.

The Endoscopic Clean Connecting Tubes includes five (5) subsets:

• Irrigation Tube;
• Clean Cap
• Clean Cap with CO2 Source Tube
• Hybrid Irrigation Tubing
• Hybrid Irrigation Tubing With CO2 source tube

The Endoscopic CO2 Source Tubing is designed to be attached to the air/water bottle tubing and the outlet of the CO2 insufflator to provide irrigation and CO2 insufflation through the air/water channel to the distal end of endoscope. It is composed of one female luer connector, one male luer connector, one rigid tube and air/gas filter. The air/gas filter can filter particulates from the CO2 source and keeps fluid from flowing into the CO2 Source.

The Endoscopic Clean Connecting Tubes and CO2 Source Tubing are provided sterile. The both device is sterilized by EO and the shelf life is three (3) years.

The provided text describes a 510(k) premarket notification for "Endoscopic Clean Connecting Tubes" and "Endoscopic CO2 Source Tubing." This documentation focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the performance of an AI/ML device against specific acceptance criteria.

Therefore, I cannot provide the information requested in the prompt because the provided text pertains to a Class II medical device (endoscopic accessories) and not an AI/ML device. The submission does not describe an AI/ML algorithm requiring a test set, expert ground truth labeling, MRMC studies, or standalone performance metrics for an AI system. The non-clinical testing mentioned refers to standard medical device performance tests like water flow rate, leakage, compatibility, and biocompatibility, not AI performance metrics.

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