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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 -
• Microdialysis Analyzer (CMA 600, ISCUS or ISCUS108) -
• -Reagents lactate, pyruvate, glucose, glycerol and glutamate
• -Control Samples
• Rinsing Fluid -
• -Calibrator A
  The 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. The microdialysis samples are analyzed in the Microdialysis Analyzer for the concentrations of glucose, lactate, pyruvate, glycerol and glutamate, 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.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, or MRMC studies. The document is a 510(k) summary for the CMA Cerebral Tissue Monitoring System, primarily focusing on its description, intended use, and comparison to a predicate device for regulatory clearance. It confirms that the device is substantially equivalent to a previously cleared device but does not detail the specific studies you are asking for.

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