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The IOB Warming Blankets are indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated.

The IOB warming blankets are used with the IOB Temperature Management System (previously cleared K162679) that draws ambient- temperature air through a 0.2 micron particulate air filter. The filtered air is warmed to a selected temperature. The warmed air enters the IOB Warming Blanket through the hose and is distributed through delivery channels. Perforations on the patient side of the air delivery channels in the warming blanket gently disperse the warmed air over and around the patient.

These blankets are single-use and disposable. Each blanket consists of two layers of non-woven polypropylene fabric coated with a layer of polyethylene. The layers are bonded together to form a distribution network of air delivery channels. The warm air is distributed around the blanket through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side of the blanket.

The provided text describes information about the IOB Warming Blankets, but does not contain details about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

The document is a 510(k) summary for a medical device (IOB Warming Blankets) for thermal regulation, arguing for substantial equivalence to a predicate device. It focuses on the physical and functional characteristics of the warming blankets themselves (e.g., material, dimensions, shelf life, sterility) and standard non-clinical tests (temperature uniformity, stability, transport testing, bubble testing, biocompatibility).

There is no mention of AI or machine learning, nor any performance metrics that would typically apply to such devices (e.g., sensitivity, specificity, AUC). Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria and studies for an AI/ML device from the provided text.

The closest relevant information, though not for an AI/ML device, is related to the performance of the warming blankets:

Non-Clinical Tests:

• Temperature uniformity tests: Measured five testing points on the blanket surface at different IOB Warmer settings.
• Real-time stability tests: Showed a three-year shelf-life.
• Simulated transport testing: Performed according to ASTM D4169.
• Bubble testing: Carried out according to ASTM F2096.
• Biocompatibility tests: Reported in the previously cleared K162679.

Reported Performance/Results from Non-Clinical Tests:

• Temperature uniformity equivalence: "All test results show temperature uniformity equivalence between the IOB warming blankets and the predicate."
• Shelf-life: "three years shelf-life"
• Transport testing: "No package damage was observed. All product hold integrity after the transport testing."
• Bubble testing: "No leakage was found."

However, this does not align with the acceptance criteria and study proving device performance as typically described for an AI/ML device.

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