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The Bair Hugger temperature management system is indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the Bair Hugger temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Bair Hugger temperature management system can be used with adult and pediatric patients.

The Bair Hugger temperature management system consists of a portable forced-air temperature management unit (series 500 or 700 units) and a disposable Bair Hugger forced-air blanket (various models).

This document is a 510(k) summary for a modified product labeling for the Bair Hugger Temperature Management System. It primarily focuses on regulatory approval based on substantial equivalence to previously cleared devices.

Therefore, the provided text does not contain information about acceptance criteria and a study proving the device meets those criteria.

Specifically, the document states:

• "The technological characteristics of the cleared devices do not change with this modification to product labeling." This indicates that no new performance studies were conducted or required, as the device's technical specifications and function remain the same. The submission is for modifying the product labeling, not for a new or significantly modified device requiring new performance evaluations.

As a result, I cannot provide the requested information from the given text.

To address your request, if this were a document detailing a new device or significant modification requiring performance studies, I would look for sections describing:

1. Performance data/clinical data: This would typically include tables of results, statistical analyses, and comparisons to established benchmarks or predicate devices.
2. Test methods: Descriptions of how the device was tested.
3. Ground truth establishment: How the "correct" answers or outcomes were determined for the study.
4. Sample sizes: The number of subjects or cases included in the study.
5. Expert qualifications and adjudication: If human evaluation was part of the ground truth or study design.

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