(48 days)
The Glucommander is intended to evaluate the current as well as cumulative patient blood glucose values, and, based on the aggregate of those measurements, whether one or many, calculate and recommend a dose of saline, glucose, and insulin to drive the blood glucose level, either up or down, towards a predetermined target range. Once that target blood glucose range has been reached, the system's function is to recommend dosing of insulin, glucose, and saline for the purpose of maintaining the patient's blood glucose level in that target range. The system is programmed to provide intravenous dosing of glucose, saline, and insulin; as well as subcutaneous dosing of glucose and insulin. The device is not intended for use with patients with known insulin allergies or patients under the age of 18.
The Glucommander's programmed logic is not a substitute for, but rather an assist to clinical reasoning. The measurements and calculations generated by the GBGDS are intended to be used by qualified and trained medical personnel in evaluating patient conditions in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional's clinical judgment. No medical decision should be based solely on the recommended guidance provided by this software program.
The Glucommander is a simple, automated, computer-based software application that, based on frequent patient glucose measurement inputs, calculates and recommends titration of intravenous and subcutaneous insulin infusion rates and intravenous qlucose infusion and oral glucose consumption rates, calculated to medicate a patient's blood glucose level towards a specified target range. The Glucommander also provides alarms and warnings, as well as alerts for subsequent blood glucose testing and monitoring.
The provided text is a 510(k) summary for the "Glucommander Plus" device. It describes the device, its intended use, and compares it to predicate devices. However, it does not contain information about acceptance criteria, a study proving the device meets those criteria, or any details regarding test sets, training sets, ground truth establishment, or expert involvement.
The document is purely a regulatory submission for premarket notification, aiming to demonstrate substantial equivalence to previously cleared devices. It focuses on device description, intended use, and technological feature comparison, rather than clinical performance or validation studies that would outline acceptance criteria and their fulfillment.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and studies from this document.
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).