(61 days)
For thermal regulation of a patient's temperature to prevent hypothermia and/or reduce cold discomfort during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.
The Snuggle Warm® 4000 Convective Warming System, identified as a Thermal Regulation System by the FDA, consists of a Convective Warming Unit (temperature controller), a hose, and a single-use Convective Warming Blanket (including the underbody blankets). The Snuggle Warm® 4000 Convective Warming System's single-use disposable Convective Warming Blankets (including the underbody blankets) are placed in contact with the patient and attached to a warming unit via a hose with end temperature controls. The warming unit generates warm air that is distributed throughout the warming blanket to warm the patient during and after surgical procedures. It is intended for thermal regulating a patient's temperature to prevent hypothermia by a warm air heated blanket system to reduce cold discomfort during and after surgical procedures. The Pediatric and Large Pediatric Underbody Blankets are single-use Convective Warming Blankets that will be added to the existing Convective Warming Blanket family. The Pediatric and Large Pediatric Underbody Blankets are components of the Snuggle Warm 4000 Convective Warming System of which the indications for use remains the same.
The provided text is related to a 510(k) summary for a medical device (Level 1® Snuggle Warm® Pediatric Underbody Blanket). However, it does not contain the specific information required to complete a table of acceptance criteria and device performance for an AI/ML-based medical device study, nor does it describe a study of that nature.
Here's why and what information is missing:
- Device Type: The device described is a convective warming system (a physical blanket and warming unit), not an AI/ML-based diagnostic or prognostic tool. Therefore, the concepts of "algorithm performance," "ground truth," "expert consensus," "training set," "test set," "MRMC study," and metrics like sensitivity, specificity, or AUC are not applicable to this submission.
- Study Type: The submission explicitly states "Clinical Data: Not required" and focuses on "Bench testing" to demonstrate substantial equivalence to a predicate device. This bench testing would involve physical measurements and adherence to specific engineering standards (ASTM F2196:2002, ISO 10993-1 2003), not AI/ML model performance evaluation.
- Acceptance Criteria & Performance: The document mentions that the blankets are "designed to meet the requirements of the following standards" (ASTM and ISO). These standards are the acceptance criteria for the physical performance (e.g., temperature regulation, biocompatibility). However, the specific quantitative performance reported against these standards (e.g., actual temperature range achieved, specific biocompatibility test results) is not detailed in this summary.
Therefore, I cannot fulfill your request as the provided input does not describe an AI/ML-based medical device or a study involving its performance evaluation with the requested metrics.
If you provide a document detailing an AI/ML medical device study, I would be able to extract the requested information.
§ 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).