(132 days)
The StatStrip Xpress Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, areonate arterial whole blood and neonate heel stick specimens.
The StatStrip Xpress Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal arterial samples throughout all hospital and all professional healthcare settings.
The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick.
It is not intended for use with neonate cord blood specimens.
It is not intended for the screening or diabetes mellitus but is indicated for use in determining dysglycemia.
The StatStrip Xpress Glucose Hospital Meter System is a hand-held testing device that works in conjunction with the StatStrip Glucose Test Strips. Meter operation is self-prompting using a segmented liquid crystal display (LCD) and icons. Function and data selection is accomplished using 3 push buttons. The handheld meter supports audible alerts and prompts with a built-in beeper. In addition to measuring glucose, the meter also stores up to 400 patient test records. The user can recall and review test results. A single coin battery powers the device. The StatStrip Glucose Hospital Meter Test Strips are designed with an electrode that measures Glucose levels. Glucose in the blood sample mixes with reagent on the test strip that produces an electric current. The amount of current that is produced depends on how much Glucose is in the blood. The strip is designed such that when a drop of blood is touched to the end of the strip, the blood is drawn into the reaction space via capillary action.
The provided text is a 510(k) premarket notification letter and summary for a blood glucose meter. It describes the device, its intended use, technological characteristics, and compares it to a predicate device. However, it does not contain the detailed information necessary to answer your specific questions related to acceptance criteria, test set characteristics (sample size, data provenance, expert adjudication, MRMC study, standalone performance), or training set information for an AI-based device.
The device in question, the "StatStrip Xpress Glucose Hospital Meter System," is a traditional in vitro diagnostic (IVD) device for measuring glucose, not an AI/ML-based medical device. Therefore, the concepts of "AI assistance," "human readers," "ground truth establishment using experts," "training sets," and "test sets" in the context of AI model evaluation are not applicable here.
The document discusses performance verification testing to demonstrate substantial equivalence to a predicate device, specifically noting a minor change in the lower operating temperature limit. This type of testing for IVD devices typically involves analytical performance studies (e.g., accuracy, precision, linearity, interference) rather than AI model evaluation metrics or expert ground truth adjudication.
Therefore, I cannot extract the requested information from the provided text because it describes a different type of medical device evaluation than what your questions presuppose (i.e., an AI/ML device approval).
To answer your questions, I would need a document that specifically details the regulatory submission and study for an AI/ML-based medical device.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.