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The Micromed BRAIN QUICK system is intended to acquire and store physiological signals for EEG and/or polysomnography (PSG) and to transfer data to separate PSG analysis software.

The system includes:

-hardware recorders intended to acquire and temporarily store physiological signals for EEG and/or PSG and to transfer the data to separate polysomnographic analysis software, and

-software which is used for the signal acquisition, display, storage, process and measure of biologic signals.

The hardware recorders (amplifiers) are BRAIN SPY PLUS, MORPHEUS, SD LTM 32 EXPRESS and SD LTM 64 EXPRESS. They are intended to acquire the same kind of signals by using the SystemPlus EVOLUTION software. The recorder models differ based on the number of available EEG channels (16 in the BRAIN SPY PLUS, 24 in the MORPHEUS, 32 in SD LTM 32 EXPRESS and 64 in SD LTM 64 EXPRESS). A system with up to 256 channel can be obtained by cascading 4 SD LTM 64 EXPRESS amplifiers.

The device is intended to be used by physicians, technicians, and other medical professions that are trained in EEG and/or PSG.

The Micromed BRAIN QUICK System is a multi-modal physiological recording system, for use in research institutions, clinics, hospitals, operating rooms, epilepsy monitoring unit environments and/or sleep laboratories. The Micromed BRAIN OUICK System is a modular system which can be configured in different versions; however, the intended use, operating principle and technology remain the same for the different configurations of the Micromed BRAIN QUICK system. The basic unit consists of one or more acquisition amplifiers, a communication interface for transferring data to a PC, a PC with monitor and user interface devices and software for the processing, storage and display of the acquired traces. The power supply is provided through an isolation transformer allowing the connection of several devices to the transformer secondary winding.

The Micromed BRAIN QUICK system acquires EEG signals (bio-potential derived from the brain activity) from third-party commercial electrodes connected to the patient. The Micromed BRAIN QUICK system processes the signal (amplification and filtering), converts it from analogical to digital representation and transmits the result to the software which controls the display of the resulting signal on a monitor, the storage of the signal on a digital storage media (e.g. hard disk or DVD), the analysis for deriving signal measures. The clinical meaning of the displayed trace is determined by the physician only, based upon the signal morphology.

The device is not intended to directly come in contact with any part of the patient body. The device uses and is compatible with EEG commercial electrodes. The device is neither sterile nor sterilizable. It is reusable. The expected lifetime is ten years.

The provided text is related to a 510(k) premarket notification for the Micromed BRAIN QUICK System. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing new performance criteria or conducting studies to prove a specific level of diagnostic accuracy against a ground truth.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in terms of diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, the performance testing described is primarily focused on safety and electrical compatibility to show equivalence.

Specifically, the document states:

• "No specific guidance document on performance is required for EEG/PSG devices."
• "The device capability is equivalent to the features specified for predicate devices."
• "Safety Tests have been performed to verify compliance with IEC 60601-1 and IEC 60601-2-26..."
• "Electromagnetic Compatibility tests according to IEC 60601-1-2 have been performed..."

Given this, I cannot construct the table or provide details for the requested study components because the provided text does not describe such a study for the device. The focus is on technical and functional equivalence to already-marketed devices, not on proving a specific clinical performance threshold for a new diagnostic capability.

If you have a document that describes a clinical performance study for an AI/diagnostic device, I would be happy to analyze it against these criteria.

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