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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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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..

The IOB Warming Blankets in this submission are the following:

Jackson Warming Blanket IOB-024
Infant Full Body/Under Body Blanket IOB-025
Large Half Body Blanket IOB-026
Large Full Body Blanket IOB-027
Infant Under Body Blanket IOB-028
Lithotomy/Orthopedic Under Body Blanket IOB-029
Small Size Warming Suit IOB-301
Medium Size Warming Suit IOB-302
Large Size Warming Suit IOB-303
Extra Large Size Warming Suit IOB-304

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 is a 510(k) summary for the IOB Warming Blankets (K190221). It describes the device, its intended use, and its substantial equivalence to a predicate device (K162679 IOB Temperature Management System).

However, the information requested about acceptance criteria and the study that proves the device meets the acceptance criteria, particularly regarding details like sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/Machine Learning-based medical devices, is not present in this document.

This document pertains to a Class II medical device (Thermal Regulating System), which falls under a different regulatory pathway than AI-powered diagnostic or predictive tools. The approval here is based on substantial equivalence to a predicate, not necessarily on a de novo clinical performance study against specific acceptance criteria for AI model performance.

The document states:

• "Clinical Studies Not applicable" (Section 10, point 4)
• The safety and performance characteristics mentioned are related to:
  • Temperature uniformity tests: "show equivalence between the IOB warming blankets and the predicate." (This implies a comparison, but not detailed acceptance criteria or methodology for an AI-based system).
  • Accelerated stability tests: "show three years shelf-life of the IOB warming blankets." (This is a physical product test, not AI performance).
  • Biocompatibility tests: "were reported in the previously cleared K162679." (Again, physical product testing).

Therefore, I cannot provide the requested table and detailed information as the provided text does not contain data related to the performance evaluation of an AI/ML-based medical device against acceptance criteria.

The prompt's questions are highly specific to the evaluation of AI/ML algorithms, which is not the subject of this 510(k) submission.

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