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The WarmTouch Patient Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia and/or shivering in the critical care environment.

The Warm Touch® CareDrape™ Cardiac Blanket is similar to the CareDrape™ Lower Body Blanket in use, as both are used in the operating room to help manage the patient's body temperature. The WarmTouch® CareDrape™ Cardiac Blanket is similar to the CareQuilt™ Full Body/ Multi-Access Warming Blanket, as both are equipped with slits, which can be opened for access to the patient through the blanket. The kev difference between the Cardiac Blanket and all earlier WarmTouch® blankets is that the Cardiac Blanket is sterile permitting use of the blanket within the sterile field.

The provided text describes performance testing for a medical device (WarmTouch® CareDrape™ Cardiac Blanket) to demonstrate its substantial equivalence. The document is a 510(k) summary, which focuses on device-specific physical and functional characteristics rather than clinical AI algorithm performance. Therefore, many of the requested categories related to AI performance, such as human experts, ground truth establishment, training sets, and AI assistance effect sizes, are not applicable to this submission.

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Acceptance Criteria and Reported Device Performance

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