(115 days)
Not Found
The device is a Class II device, System Thermal Regulating 74 DWG, Patient Warming System called the Bair Hugger® Total Temperature Management System®-Modification.
This looks like a 510(k) summary for a medical device (a rolling stand for a patient warming system), not an AI/ML powered device. The questions you've asked (acceptance criteria, study details, ground truth, MRMC studies, etc.) are highly relevant to the evaluation of AI/ML diagnostic devices, but they don't apply to a physical device like a rolling stand.
Therefore, I cannot provide the requested information because the provided text describes a physical medical device (a rolling stand) and not an AI/ML powered diagnostic device that would have a "reported device performance" against specific "acceptance criteria" through a "study" involving "ground truth," "experts," or "training sets."
The document focuses on the safety and effectiveness of the rolling stand in terms of physical stability and proper usage with its intended warming unit, not on diagnostic accuracy based on an algorithm.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).