Search Results

The Arctic Sun™ Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.

The Arctic Sun Stat Temperature Management System is a non-invasive, thermal regulating system that monitors and controls patient temperature within a range of 32°C to 38.5°C (89.6° F to 101.3°F). The system consists of the Arctic Sun Stat Control Module, associated accessories, and is used with the ArcticGel Pads. The Arctic Sun Stat Control Module and associated accessories are the subject of this submission. The Arctic Sun Stat Control Module circulates temperature-controlled water ranging between 4°C and 40°C (39.2°F and 104°F) through the ArcticGel Pads, resulting in heat exchange between the water and the patient. A commercially available YSI 400 series compatible patient temperature probe connected to the Arctic Sun Stat Control Module provides patient temperature feedback to an internal control algorithm, which automatically increases the circulating water temperature to achieve a pre-set patient target temperature determined by the clinician. The Arctic Sun Stat Control Module has the option to provide secure data output of device monitoring values; there is no patient-identifiable information. The data output functions, including USB, RS-232, and Wi-Fi, do not allow the user to write to the device and are intended for user convenience only.

This document is a 510(k) summary for the Arctic Sun Stat Temperature Management System. It states that "No clinical testing was required to evaluate the changes for substantial equivalence" and "No clinical data or testing was required to evaluate the proposed device modifications that are the subject of this submission."

Therefore, the provided text does not contain the information requested regarding acceptance criteria and the study that proves the device meets them, specifically:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document describes performance testing based on established methods, standards, and guidance documents to demonstrate substantial equivalence, but it explicitly states that no clinical data or testing was required. This implies that formal studies involving human subjects, expert adjudication, or complex ground truth establishment (as would be typical for AI/ML device evaluations) were not conducted for this 510(k) submission.

The "Summary of Performance Testing Used to Establish Substantial Equivalence" section mentions tests like "Artificial patient" and "Graphical user interface (GUI) testing," which are engineering or bench tests, not clinical studies involving patient data or human readers.

Ask a specific question about this device