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Temperature reduction for adult patients where clinically indicated, e.g. in hyperthermic patients.

The EMCOOLSpad is a single use surface (skin) cooling device, which is adherent to the patien's skin and so highly adjustable during the cooling procedure. An EMCOOLSpad consists of multiple cooling-cells made of thermoplastic polyurethane, filled with high thermal conductivity material, stored frozen at 0 to -10°C.

The provided text describes the EMCOOLSpad, a hypothermia system, and its substantial equivalence to predicate devices, but it does not contain information related to acceptance criteria, specific clinical studies with performance metrics, sample sizes for test or training sets, expert qualifications, adjudication methods, or MRMC studies.

The document focuses on:

• Device Description: How the EMCOOLSpad works as a single-use surface (skin) cooling device.
• Comparison to Predicate Devices: A table outlining shared technological characteristics with the Arctic Sun® Model 2000 and Thermosuit™ Hypothermia System, concluding substantial equivalence based on functional criteria.
• Biocompatibility Testing: Performed according to ISO standards by an accredited lab.
• Performance Testing - Bench: Internal R&D testing showed no difference in cooling rate compared to ArcticSun®, and it was less aggressive than ThermoSuit™, suggesting better physiological tolerance.
• Performance Testing - Animal: Demonstrated "under-the-pad" skin safety on pigs after 24 hours and 1 week.
• Conclusion: The device performs as intended and raises no new safety or effectiveness issues.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details as that information is not present in the provided text.

Based on the provided text, there is no information available to answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or clinical performance metrics. The document is a 510(k) summary focused on demonstrating substantial equivalence through device description, comparison to predicates, and limited non-clinical testing (biocompatibility, bench, and animal studies for skin safety).

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