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The Medline ComfortTemp Patient Warming System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient themal comfort when conditions exist that may cause patients to feel too warm or too cold. The temperature management system can be used with adult and pediatric patients.

The Medline ComfortTemp Patient Warming System is intended to prevent and treat hypothermia. In addition, the patient warming system provides thermal comfort when conditions exist that may cause patients to feel too warm or too cold. The patient warming system is for adult and pediatric patients. The Medline ComfortTemp Patient Warming System is used in acute care, post-acute care, operating room, and procedural rooms. The system consists of a reusable blower unit, a reusable hose, and single-patient use, disposable blankets. Replacement filters and hoses for the blower unit are additionally available as needed. All components of the ComfortTemp Patient Warming System are non-sterile. The blower unit connects to the single-patient use blanket through a reusable hose and provides forced warm air into the blanket using a PTC (positive temperature coefficient) heater, a fan/blower and a user-controlled interface. Depending on the model, the ComfortTemp blanket is placed either around, over, or underneath adult and/or pediatric patients. The blanket is comprised of two polypropylene and polyethylene layers, which allow the forced warm air to be dispersed over the patient's skin.

This document describes the FDA clearance for the Medline ComfortTemp Patient Warming System, declaring it substantially equivalent to a predicate device. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in terms of a digital health or AI/ML device.

The document discusses various performance tests conducted on the device, such as airflow testing, temperature verification, material strength, and biocompatibility. However, these are engineering and safety tests rather than performance evaluations against clinical acceptance criteria for an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert involvement as these details are not present in the provided text. The text does not describe an AI/ML device or a study with such methodologies.

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