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The CMA Cerebral Tissue Monitoring System measures intracranial glucose, lactate, pyruvate, glycerol and glutamate levels and is intended as an adjunct monitor of trends in these parameters indicating the perfusion status of cerebral tissue local to catheter placement. Because the CMA System values are relative within an individual, these should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide additional data to that obtained by current clinical practice in cases where ischemia or hypoxia is a concern.

The CMA Cerebral Tissue Monitoring System utilizes the principles of "microdialysis," to monitor biochemical markers of ischemia in the brain. The system consists of the following components:

• CMA 70 Brain Microdialysis Catheters -
• CMA 106 Pump and Syringe -
• Perfusion Fluid CNS -
• Microvials and Microvial Racks -
• ISCUS Clinical Microdialysis Analyzer or CMA 600 Microdialysis Analyzer and software
• -Reagents lactate, pyruvate, glucose, glycerol and glutamate
• Control Samples l
• Rinsing Fluid - -
• -Calibrator A
  The CMA 70 Brain Microdialysis Catheter mimics the function of a blood capillary. Molecules in the interstitial fluid diffuse over the sterile, semi-permeable dialysis membrane of the catheter into the Perfusion Fluid, which is pumped by the CMA 106 Microdialysis Pump. The Perfusion Fluid equilibrates with the surrounding interstitial fluid and is collected in microvials at the outlet of the catheter. The microvials are changed regularly by the appropriate hospital staff and brought to the Microdialysis Analyzer (CMA 600 or ISCUS). The dialysate is analyzed for the concentrations of glucose, lactate and pyruvate, which are well-known markers of tissue ischemia. The data are displayed as trend curves on the screen of the analyzer showing the local changes in the hypoxic/ischemic state of the brain tissue.

The provided text does not contain information regarding an acceptance criteria table, device performance metrics, sample sizes for test sets, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, types of ground truth, or details about the training set.

The document is a 510(k) summary for the CMA Cerebral Tissue Monitoring System, outlining its description, intended use, and comparison to predicate devices, and a letter from the FDA issuing a substantial equivalence determination. It focuses on regulatory approval based on equivalence rather than performance studies against specific acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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