(103 days)
The EpochXP Neurological Monitor is intended for use in the operating room and critical care areas for neurological monitoring and assessment. The instrument uses EEG, evoked potentials and EMG techniques to provide health care professionals with information to help assess a patient's neurological status and guide treatment during surgery or long term monitoring in the ICU
The EpochXP 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 demanding requirements for comprehensive neurological monitoring in the electrically hostile operating room and critical care environments.
The EpochXP can be used to monitor neurological data using either individual or multimodality EEG, EMG and evoked potential test protocols. The main EpochXP system components include: CPU, interface enclosure, data acquisition module, sensory and motor electrical stimulator, stimulator extension boxes, LED goggles and insert earphones.
Recording electrodes, placed on the patient, are connected the digital preamplifier (data acquisition module) The signal is amplified, filtered, optically isolated and converted to a digital signal. The digitized data is then routed to the digital signal processing (DSP) board located in the interface enclosure. The DSP processes the data and controls timing for the stimulators. The CPU acts as the user interface for setting parameters and controls and for display of the processed data.
Data from external devices, such as vital signs monitors, can be imported to the EpochXP display screen, allowing the operator to correlate changes in neurologic function with the patient's systemic vital signs. In addition, a display window may be opened to observe the surgeon's microscope view on screen. The EpochXP is network compatible for data review within the hospital and permits secure information access over the Internet.
I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. The text primarily focuses on the administrative details of a 510(k) submission for the EpochXP Neurological Workstation, including its description, intended use, and substantial equivalence to predicate devices. It does not provide any specific quantitative acceptance criteria or report on any studies (clinical or non-clinical) that demonstrate the device's performance against such criteria.
Therefore, I cannot extract information for the following points as they are not present in the provided document:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).