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The Eclipse neurological workstation is intended for use to monitor sensory and motor pathways in the operating room and critical care areas. The instrument uses electroencephalography (EEG), electromyography (EMG), motor and sensory evoked potentials and nerve potentials to provide health care professionals with information to help assess a patient's neurological status. Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract.

The Eclipse Neurological Workstation provides continuous monitoring of brain and neural pathways intraoperatively or in the intensive care unit. The system has been designed to meet the requirements for comprehensive neurological monitoring in the operating room and critical care areas.

The Eclipse Neurological Workstation can be used to monitor neurological data using either individual or multimodality EEG, EMG and evoked potential test protocols.

The main Eclipse system components include: computer, controller, digital preamplifiers, direct nerve, sensory and motor evoked potential electrical stimulators, stimulator extension modules, LED goggles and insert earphones. The Eclipse also provides support for the Nonin XPod pulse oximeter module and high impedance preamplifier module to allow recording from high impedance electrodes.

Recording electrodes detect spontaneous or stimulus evoked electrophysiological activity and are used as inputs to the digital preamplifier. The electrophysiological signals are amplified, filtered, optically isolated and digitized. The digitized data is then routed to the digital signal processor (DSP) located in the Eclipse controller. The DSP processes the data and controls timing for the electrical, audio and visual stimulators. The computer controls the user interface for setting parameters and the display of processed data.

A built-in pulse oximeter provides pulse rate and oxygen saturation measures. Data from external devices, such as vital signs or other physiological monitors, can be imported to the Eclipse display screen, allowing the operator to correlate changes in neurological function with the patient's systemic measurements. In addition, a display window may be opened to observe the surgeon's microscope view or other video input. The Eclipse is network compatible for data review within the hospital and permits secure information access over the Internet.

The provided text is a 510(k) summary for the Eclipse Neurological Workstation. It outlines the device's intended use, classification, and substantial equivalence to predicate devices. However, the document does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot populate the requested table or answer the specific questions about the study that proves the device meets acceptance criteria based solely on the provided text.

The information given primarily focuses on:

• Identifiant: K050798
• Device Name: Eclipse Neurological Workstation / Eclipse Lite Neurological Workstation
• Applicant: Axon Systems, Inc.
• Contact: Howard Bailin
• Common Name: Electroencephalograph (EEG Monitor), Evoked Potential (SEP, BAEP, AEP, VEP, MEP) System, EMG Monitor
• Classification Name: Electroencephalograph, Evoked Response, Electromyograph
• Regulation Numbers: 21 CFR 882.1400, 21 CFR 882.1420, 21 CFR 882.1870, 21 CFR 882.1570, 21 CFR 882.1620, 21 CFR 882.1900
• Product Codes: GWQ, GWS, GWF, GWE, GWJ, CAB
• Predicate Devices: Axon Systems - EpochXP (K032741), Digitimer - D185 (K020400), NuVasive - Neurovision JJB (K032083), Grass Telefactor - AS40 Amplifier (K021807)
• Device Description: Provides continuous monitoring of brain and neural pathways intraoperatively or in the intensive care unit using EEG, EMG, and evoked potential test protocols. It includes a computer, controller, digital preamplifiers, various stimulators, and support for pulse oximetry and external device data import.
• Indications for Use: Intended for use to monitor sensory and motor pathways in the operating room and critical care areas. It uses EEG, EMG, motor and sensory evoked potentials, and nerve potentials to provide health care professionals with information to help assess a patient's neurological status. Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract.
• Conclusion: The device is claimed to be safe, effective, and substantially equivalent to the predicate device(s).

To answer your full request, you would need access to the full 510(k) submission, which typically includes detailed performance data, verification, and validation studies.

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