(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.
{0}------------------------------------------------
F: 510(k) Summary of Safety & Effectiveness
Safety
K963672
JAN 6, 1997
This 510(k) Summary of Safety & Effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The device is a Class II device, System Thermal Regulating 74 DWG, Patient Warming System called the Bair Hugger® Total Temperature Management System®-Modification. The following summarizes safety issues related to the use of rolling stands and the measures to prevent these problems.
Summary of Safety: 1.
- A. Stability:
The Rolling Stand could be inadvertantly tipped over.
Prevention: The Rolling Stand has 5 legs to provide additional stability and meets the stability requirements of UL 2601-1 and IEC 601-1
- B. Use of stand with unapproved devices or products:
Use of the rolling stand with any device or product other than those provided by Augustine Medical, Inc. could result in damage to the stand, the attached product, or in the stand tipping over.
Prevention: Instructions packaged with the Model 90022 Rolling Stand include the statement "The Rolling Stand is not intended to be used with any device or product other than those provided by Augustine Medical, Inc."
2. Summary of Effectiveness
The Model 90022 Rolling Stand effectively supports the Bair Hugger Model 505 Warming Unit and provides effective transportation of the unit when used under normal operating conditions.
Contact: Scott D. Augustine, M.D., CEO Augustine Medical, Inc.
§ 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).