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ClearLine IV™ is intended for detection and automatic removal of air in intravenous (IV) lines during administration of IV solutions, blood, and blood products. It is indicated for use in critical care areas such as the operating room (OR), postanesthesia care unit (PACU), and intensive care unit (ICU). ClearLine IV™ is placed between the patient and the V source and can be used with or without fluid warmers.

The ClearLine IV™ is a modification to the predecessor device, the AirPurge™ System. Both devices consist of two main components, the control unit and the sterile, single-use disposable cartridge. The control unit is mounted to the I.V. pole using a pole clamp attached to the back of the control unit. The disposable cartridge is loaded onto the control unit and connected to the infusion line between the infusion source and the patient. During infusion, air entering the cartridge will be detected by an ultrasonic sensor in the control unit, which will automatically close the patient line and divert the fluid flow containing the air to the waste collection bag. A second ultrasonic sensor in the control unit monitors the line to the waste collection bag. When both sensors detect liquid again, flow to the patient is resumed.

The provided text describes a 510(k) premarket notification for a medical device called ClearLine IV™, an automated air removal system for IV lines. It focuses on demonstrating the device's substantial equivalence to a predicate device (AirPurge™ System) through non-clinical testing.

However, the document does not contain information related to a study that proves the device meets acceptance criteria through the analysis of "reported device performance" in the context of an AI/ML-based medical device evaluating images or data with human experts.

The "acceptance criteria" and "device performance" described in the document relate to functional requirements of a mechanical/electronic device (e.g., air sensor response time, minimal detectable air volume, flow rates, software functions, electrical safety, biocompatibility, sterilization validation, package integrity, and human factors).

Therefore, it's not possible to extract the requested information (table of acceptance criteria with reported device performance for an AI/ML output, sample sizes for test/training sets in an AI/ML context, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, type of ground truth used for AI, etc.) from the provided text.

The document explicitly states under "J. Clinical Testing": "Clinical testing was not required to support this 510(k)." This further indicates that the device's validation did not involve studies with human subjects or expert readers interpreting data in a clinical performance setting as would be expected for an AI/ML medical device.

In summary, the provided text does not contain the information necessary to describe an AI/ML device's acceptance criteria and the study that proves it meets those criteria in the manner requested by the prompt.

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