(17 days)
The Radiant Medical Reprieve® Endovascular Temperature Therapy System is a thermal regulating device intended to induce, maintain, and reverse mild hypothermia in neurosurgical patients in surgery and in recovery/intensive care.
The Reprieve System consists of a single-use, heparin-coated, central venous catheter; a single-use, heat exchange cassette; an integrated temperature probe; and an external controller. The Controller unit has a user interface to select operating parameters and is connected to the Catheter via the Cassette and extension lines. The catheter is designed for placement in the inferior vena cava via the femoral vein using a 12 Fr hemostatic introducer sheath.
The provided text is a 510(k) summary for the Radiant Medical Reprieve® Endovascular Temperature Therapy System. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain the detailed information required to describe acceptance criteria, a specific study proving those criteria were met, or the specifics of such a study for an AI/ML device.
The "Performance Test" section states: "The Reprieve Endovascular Temperature Therapy System has been tested for system performance substantially equivalent to the predicate devices. In addition the Catheter has been tested for functionality in accordance to BS EN ISO 10555, for biocompatibility in accordance to ISO 10993, and for sterility in accordance to ISO 11137. The controller has been tested for electrical safety in accordance to IEC 60601."
This statement indicates that the device met established international standards for medical devices and demonstrated substantial equivalence to predicate devices, but this is a regulatory compliance statement and not a detailed account of an AI/ML clinical validation study. The Reprieve® Endovascular Temperature Therapy System is a hardware-based thermal regulating device, not an AI/ML-powered diagnostic or therapeutic system. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML algorithm (e.g., sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this device as described.
To answer your request based only on the provided text, I can only state what is present, which is the system was tested for substantial equivalence and adherence to specific international standards, not against AI/ML performance metrics.
Therefore, I cannot provide the requested table and detailed information because the provided document describes a hardware medical device, not an AI/ML algorithm, and thus does not contain the information relevant to AI/ML acceptance criteria and study designs.
§ 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).