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The Patient Warming System manufactured by Adroit Medical Systems is designed for the operating room (exclusive of the sterile surgical field), recovery room, anesthetic room, ICU, Medical/Surgical floors, in-hospital patient transport and emergency rooms. The Patient Warming System provides safe and controlled surface warming to assist adult patients to maintain normal body temperature.

Soft Air Patient Warming System: Blower Model SA4000 (110V) Mistral Air Patient Warming System: Blower Model MA0100 (220V) Soft Air Blankets (Non-sterile): Model 1187: Adult Full Body Model 1843: Adult Lower Body Model 1846: Adult Upper Body

This is a 510(k) clearance letter for a patient warming system (blower and blankets). This type of device is not an AI/ML powered device, and therefore the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, is not present in the provided text.

The letter addresses the substantial equivalence of the Soft-Air SA4000 and Mistral-Air MA0100 blanket models to legally marketed predicate devices, which is the basis for 510(k) clearance.

Therefore, I cannot provide the detailed information requested about acceptance criteria and AI/ML study specifics based on this document.

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