(48 days)
The Epoch XP 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 during surgery or long term monitoring in the ICU.
The Epoch XP Neurological Workstation provides continuous monitoring of brain and neurologic electrical activity for applications 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 Epoch XP can be used to monitor neurological data using either individual or multimodality EEG, EMG and evoked components include: CPU, interface enclosure, data acquisition module, electrical 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 Epoch XP 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 Epoch XP is network compatible for data review within the hospital and permits secure information access over the Internet.
Based on the provided text, the submission is an FDA 510(k) summary for the Epoch XP Neurological Workstation. This document primarily focuses on establishing substantial equivalence to a predicate device (Epoch 2000 K971819) rather than detailing a specific clinical study with acceptance criteria and device performance as typically seen for novel AI/ML devices.
Here's an breakdown of the information that can be extracted, and what is not present:
Information Present in the Document:
- Device Name: Epoch XP Neurological Workstation (and Epoch XP Lite Neurological Workstation)
- Intended Use/Indications for Use: The Epoch XP 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 healthcare professionals with information to help assess a patient's neurological status during surgery or long-term monitoring in the ICU.
- Predicate Device: Epoch 2000 (K971819)
- Classification: Class II
- Description: The Epoch XP provides continuous monitoring of brain and neurologic electrical activity. It's designed for comprehensive neurological monitoring in electrically hostile operating room and critical care environments. It can monitor neurological data using individual or multimodality EEG, EMG, and evoked potentials.
Information NOT Present in the Document (and why):
This document is a 510(k) summary for an electrophysiological monitoring device (EEG, evoked potentials, EMG monitor), which is a conventional medical device, not an AI/ML device. Therefore, the detailed performance metrics, study design, and ground truth establishment typically required for AI/ML device submissions (especially those involving image analysis or diagnostic support) are not included. The focus of a 510(k) for such a device is on demonstrating that it is as safe and effective as a legally marketed predicate device, often through engineering and comparative testing, rather than a clinical trial proving a specific diagnostic accuracy against a ground truth.
Specifically, the following requested information is not available in the provided text:
- 1. A table of acceptance criteria and the reported device performance: This type of quantitative performance data is not presented. The document asserts substantial equivalence based on concept, function, and meeting design and development criteria, validated and verified.
- 2. Sample size used for the test set and the data provenance: No test set or data provenance details are provided.
- 3. Number of experts used to establish the ground truth for the test set and their qualifications: Ground truth for a test set is not discussed as no such test is detailed.
- 4. Adjudication method for the test set: Not applicable as no test set is described.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable; this type of study is for diagnostic performance of AI, not for a physiological monitor.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physiological monitoring system that provides data to healthcare professionals.
- 7. The type of ground truth used: Not applicable as the device is a data acquisition and display system for physiological signals, not a diagnostic algorithm generating its own "ground truth."
- 8. The sample size for the training set: Not applicable; this device is not an AI/ML model trained on data in the usual sense.
- 9. How the ground truth for the training set was established: Not applicable.
Conclusion:
The provided document describes a conventional neurological monitoring workstation and seeks substantial equivalence to a predicate device. It does not contain the specific performance metrics, study designs, or ground truth methodologies relevant to AI/ML device evaluations. The "acceptance criteria" for this device would have primarily revolved around engineering specifications, safety standards (e.g., electrical safety, EMC), and functional equivalence to the predicate device in terms of signal acquisition, processing, and display, rather than diagnostic accuracy against a clinical ground truth dataset.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).