(69 days)
The Bair Hugger family of temperature management systems are 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 temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management systems can be used with adult and pediatric patients.
The Bair Hugger family of temperature management systems consist of a portable forcedair temperature management unit, disposable Bair Hugger forced-air blankets, and disposable Bair Paws warming gowns.
This document K053645 is a Special 510(k) for modified product labeling of the Bair Hugger family of Temperature Management Systems. It states that the "Technological characteristics of the cleared devices do not change with this modification to product labeling." This type of submission, concerning only labeling changes and explicitly stating no change in technological characteristics, typically does not involve new performance studies or acceptance criteria beyond ensuring the new labeling accurately reflects the existing, cleared device. Therefore, the information requested in the prompt regarding acceptance criteria and performance studies is not present in this document.
To answer your specific questions based on the provided text:
- A table of acceptance criteria and the reported device performance: Not provided in this Special 510(k) submission, as it relates to a labeling modification, not a new device or significant performance change study.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable for this type of submission.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of submission.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a thermal regulating system, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a thermal regulating system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for this type of submission.
- The sample size for the training set: Not applicable for this type of submission.
- How the ground truth for the training set was established: Not applicable for this type of submission.
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).