(15 days)
The TheraTest EL-aCL™screen and TheraTest EL-aCL™ IgM, InG, IgA are intended for use in clinical laboratories as an in vitro diagnostic test for the detection and measurement of autoantibodies in human serum directed against the phospholipid cardiolipin.
Not Found
I am sorry, but the provided text describes a 510(k) premarket notification for an in vitro diagnostic test (TheraTest EL-aCL™ screen and TheraTest EL-aCL™ IgM, IgG, IgA). This document is a regulatory approval letter from the FDA.
This type of device is a laboratory assay, not an AI/ML powered device, and therefore the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they apply to AI-powered medical devices (like those involving image analysis, decision support systems, etc.) are not directly relevant in the way you've framed the request with terms like "test set," "ground truth," "MRMC study," and "training set."
The document does not contain the information needed to fill out your request, as it does not describe an AI/ML algorithm or its development and validation.
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).