(175 days)
ADVIA Chemistry® Creatine Kinase (CK_L) Assay:
The ADVIA Chemistry® Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy.
ADVIA Chemistry® Enzyme 3 Calibrator:
ADVIA Chemistry® Enzyme 3 Calibrator is intended for in vitro diagnostic use in the calibration of the ADVIA Chemistry Creatine Kinase (CK L) assay on the ADVIA Chemistry systems.
ADVIA Chemistry Creatine Kinase (CK L) assay is a ready-to-use liquid reagent packaged for use on the automated ADVIA Chemistry systems. Creatine Kinase reacts with creatine phosphate and ADP to form adenosine triphosphate (ATP), which is coupled to the hexokinase-G6PD reaction, generating NADPH. The concentration of NADPH is measured by the increase in absorbance at 340/596 nm.
ADVIA Chemistry ENZ 3 CAL:
ENZ 3 CAL is a liquid frozen human serum albumin based product containing creatine kinase MM from human heart. Enzyme 3 Calibrator kit consists of six vials of the same calibrator which is ready for use (no preparation is required).
The provided document is a 510(k) Premarket Notification for an in vitro diagnostic device, the ADVIA Chemistry® Creatine Kinase (CK L) Assay and ADVIA Chemistry® Enzyme 3 Calibrator. It describes the device's technical specifications, intended use, and performance characteristics to demonstrate substantial equivalence to a legally marketed predicate device.
However, the request asks for information relevant to the development and validation of an AI/ML-driven medical device, which typically involves acceptance criteria for model performance (e.g., accuracy, sensitivity, specificity), study design for clinical validation (e.g., test set sample size, ground truth establishment by experts, MRMC studies), and training set details.
The provided document describes the analytical validation of a chemical assay, which measures the concentration of a substance (Creatine Kinase) in human samples. Its performance is evaluated through parameters like method comparison, precision, linearity, detection capability, and interference testing. These are fundamentally different from the performance metrics and study designs used for AI/ML devices, which often involve image analysis, pattern recognition, and diagnostic classification.
Therefore, the provided text does not contain the information requested regarding acceptance criteria related to AI/ML device performance, expert adjudication, MRMC studies, or training set details typical of AI/ML model development.
I cannot create the table or answer the specific questions about an AI/ML device's acceptance criteria and study data based on the provided document. The document describes a traditional in-vitro diagnostic assay rather than an AI/ML-driven device.
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.