(29 days)
The Level 1® Convective Warmer is intended to prevent and treat hypothermia when temperature therapy is clinically indicated. The warmer can also be used to provide thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Level 1® Convective Warmer can be used with adult or pediatric patients and is intended for use by appropriately trained healthcare professionals in clinical environments.
The Level 1® Convective Warmer, is a forced air thermal regulating systems which includes a connection hose to attach to the Snuggle Warm® Convective Warming Blankets for patients requiring body temperature requlation in clinical environments which are provided non-sterile and intended to be reused. In order to accommodate various clinical environments, the Level 1® Convective Warmer is able to be placed on the floor, placed on a floor cart, or mounted on an I.V. pole to allow flexible portability. The Level 1® Convective Warmer is used with the Snuggle Warm® Convective Warming Blankets.
This document is a 510(k) premarket notification for a medical device, specifically a convective warmer. It is not about an AI/ML medical device. Therefore, the information requested about acceptance criteria, study details, expert involvement, and ground truth for an AI/ML model is not available in this document.
The document focuses on establishing substantial equivalence for a physical medical device (Level 1® Convective Warmer) to a predicate device (Equator® Convective Warmer), particularly noting the introduction of a microprocessor control system in the new device where the predicate used analog circuitry. The "performance testing" described refers to engineering and safety tests for the physical device, not a performance study of an AI model's diagnostic accuracy.
Therefore, I cannot provide a response that directly answers the detailed questions about AI/ML acceptance criteria and study particulars based on the provided text. The prompt's assumptions (e.g., test sets, ground truth establishment, MRMC studies) are applicable to AI/ML device submissions, but not to this specific medical device 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).