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The CARESCAPE™* CO2 - Microstream™ parameter, when connected to the host monitor, is intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle, EtCO2, FiCO2, and CO2 based respiration rate for adult, pediatric and neonatal patients, utilizing Microstream™ Advance CO2 sampling lines. The CARESCAPE™* CO2 - Microstream™ parameter is intended for use in hospital-type facilities, during intra-hospital transport between and within areas of care.

The GE CARESCAPE™* CO2 -Microstream™ parameter is a module utilizing Microstream™ Capnography technology designed for use with specific GE Host monitors (CARESCAPE™* ONE. CARESCAPE™* B450 [K213234]. CARESCAPE™* B650 [K213181]. or CARESCAPE™* B850 [K213336]). The GE CARESCAPE™* CO2 -Microstream™ parameter comprised of two main sub-systems: - Microstream™ NanoMediCO2 is a Capnography module in its plastic enclosure called . the NanoPod, responsible for measuring the inspired carbon dioxide and respiration rate of adults, pediatric patients, and neonatal patients, - . U-MCO2-active cable module in its enclosure (called "Active cable" or "Bridge" or "Common block") responsible for enabling the bidirectional communication between the Host monitor and the NanoMediCo2 module, using the specific GE communication protocol (Taq-Length-Data). The Active Cable also acts as a power supply to the NanoPod, transferring power from the host to the pod and provides the user with an indication of the Pod's functional status. The NanoPod mates on one side with the Microstream™ Advance Filter Lines. On the other side the NanoPod attaches to GE patient monitoring system via the U-MCO2- active cable, allowing them to display the Microstream™ Capnography parameters. The U-MCO2 active cable module, is connected to an interface board located inside the active device (NanoPod), while on the other side of the U-MCO2 active cable, there is a proprietary GE (Amphenol) connector, designed to connect solely with GE Healthcare monitors. The NanoPod is activated by Microstream™ Advance Filter Lines that are connected through the blue door located on the upper side of the NanoPod.

The provided text describes the regulatory clearance of a medical device, the CARESCAPE™ CO2 - Microstream™ parameter, and its substantial equivalence to a predicate device. However, it does not include the detailed information required to fulfill the request about acceptance criteria and a study proving the device meets them.

Specifically, the document states:

• "The functional features and the indications for use of the CARESCAPE™ CO2 - Microstream™ parameter are substantially equivalent to the predicate device."
• "The CARESCAPE™ CO2 - Microstream™ parameter has successfully undergone performance, safety, electromagnetic and environmental testing to ensure compliance with expected performance standards."
• "Software testing was performed to validate the performance of the CARESCAPE™ CO2 - Microstream™ parameter and its substantial equivalence to the predicate device."
• "Animal Performance Testing: Not applicable. Animal performance testing was not necessary to show substantial equivalence."
• "Clinical Performance Testing: Not applicable. Clinical evidence was not necessary to show substantial equivalence."

This indicates that the key evidence for this device's performance relies on bench testing and software testing, demonstrating equivalence to a previously cleared device, rather than a de novo clinical study with specific acceptance criteria for a new mode of action or clinical outcome.

Therefore, I cannot provide the requested information about acceptance criteria, detailed study design (sample sizes, ground truth establishment, expert involvement, MRMC studies, etc.). The document explicitly states that animal and clinical performance testing were not necessary to show substantial equivalence, and no such study details are provided.

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