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The Disposable Suction Irrigation Tubing Set is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation normal saline to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site to aid visualization.

The Disposable Suction Irrigation Tubing Set consists of a grip body equipped with two trumpet style valves, a probe, and connecting lines of tubing; one set designed to attach a supply of irrigation normal saline, and the other designed to attach to suction equipment (aspiration pump). The valves allow for control of irrigation and aspiration during a surgical procedure. The handpiece of the suction irrigator is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments and diameters. The device is packaged as sterile with a shelf life of 3 years and is for single use only.

The provided text describes a 510(k) premarket notification for a medical device called "Suction Irrigation Tubing Set." This type of submission is for medical devices, not AI/machine learning (ML) enabled devices. The document does not contain any information about acceptance criteria or studies involving AI/ML performance, human readers, ground truth establishment for AI/ML, or training/test sets for AI/ML models.

Therefore, I cannot fulfill your request for information about acceptance criteria and the study that proves the device meets those criteria in the context of AI/ML, as the provided document pertains to a traditional medical device (Suction Irrigation Tubing Set) and its physical properties and functionality.

The document discusses:

• Device Name: Suction Irrigation Tubing Set
• Regulation Number & Name: 21 CFR 876.1500, Endoscope And Accessories
• Product Code: GCJ
• Indications for Use: Used in laparoscopic surgical procedures to deliver sterile irrigation and evacuate fluids/debris/smoke.
• Device Description: Consists of a grip body with valves, a probe, and connecting tubing for irrigation and suction.
• Predicate Device: K141592, Unimicro Suction Irrigation Tubing Set
• Non-clinical Tests Performed: Air tightness, smooth test, tensile strength, tubing collapse, irrigation/aspiration fluid flow test. These are typical physical and performance tests for medical tubing, not AI/ML performance metrics.
• Conclusion: The device is substantially equivalent to the predicate device, raising no new questions of safety or effectiveness based on technological comparison and nonclinical testing.

None of this information relates to the typical acceptance criteria or study methodologies used for AI/ML medical devices (sensitivity, specificity, AUROC, MRMC studies, expert adjudication for image interpretation, etc.).

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