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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.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

Details Not Applicable to AI Performance Studies

The following information is not present in the provided 510(k) summary because this document describes a physical medical device (a warming blanket) and its engineering performance, not an AI-powered diagnostic or therapeutic system. Therefore, concepts like "experts to establish ground truth," "adjudication," "MRMC study," "standalone algorithm performance," "training set," and "ground truth for training set" are not relevant to this submission.

• Sample size used for the test set and the data provenance: Not explicitly stated as "test set" in the context of an AI algorithm. The tests described are engineering/physical performance tests of the blanket itself. For example, "blankets were tested" for temperature, burst pressure, and tape strength. The number of blankets or specific test iterations isn't provided, but it's implied that sufficient testing was done to meet the stated criteria. Data provenance for such tests is typically from internal lab testing by the manufacturer.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a warming blanket's performance involves direct physical measurements (temperature, pressure, strength), not expert clinical interpretation.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are for resolving discrepancies in expert interpretations, which is not relevant for physical product testing.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical device, not an AI system assisting human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the physical performance tests are the direct physical measurements taken (e.g., thermometer readings for temperature, pressure gauges for burst pressure, tensile testers for tape strength).
• The sample size for the training set: Not applicable. There is no AI model being trained.
• How the ground truth for the training set was established: Not applicable. There is no AI model being trained.

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