(90 days)
The Datex-Ohmeda Entropy module , M-ENTROPY and accessories are intended to be used with Datex-Ohmeda modular multiparameter monitoring the neurophysiological status of hospitalized patients.
The Datex-Ohmeda Entropy Module is indicated for monitoring the state of the central nervous system (CNS) by data acquisition of electroencephalograph (EEG) and frontal electromyograph (FEMG) signals in the anesthesia environment. The spectral entropies, State Entropy (SE) and Response Entropy (RE), are processed EEG and FEMG variables, and may be used as an aid in monitoring the effects of certain anesthetic agents. The Entropy module is indicated for use by qualified medical personnel only.
The Datex-Ohmeda Entropy module, M-ENTROPY is a single-width plug-in parameter module for a Datex-Ohmeda modular monitoring system. The Datex-Ohmeda Entropy module, M-ENTROPY can be used with the following Datex-Ohmeda modular monitors: S/5™ Anesthesia Monitor (AM) with main software L-ANE03(A).00 or newer version, and S/5TM Compact Anesthesia Monitor (CAM) with main software L-CANE03(A)..00 or newer version. Entropy is an innovative monitoring modality which is designed to provide information on the electrical activity of the CNS during general anesthesia. Entropy monitoring is based on acquisition, and processing of raw EEG and FEMG signals by using the Entropy algorithm. The entropy algorithm is a Datex-Ohmeda application of spectral entropy based on information theory. The Datex-Ohmeda Entropy Module for the Datex-Ohmeda S/57M Monitoring system may be used as an aid in monitoring the effects of certain anesthetic agents. The Datex-Olumeda Entropy sensor is a rectangular shaped, pre-gelled array of three (3) Zipprep® electrodes that is applied to the patient's skin to record electrophysiological (such as EEG) signals. It is a low impedance, single patient use, disposable sensor that is designed for application to the frontal / temporal area. The Datex-Ohmeda Entropy sensor is designed to provide ease of use and electrode placement accuracy. The sensor is used in conjunction with M-ENTROPY. The Datex-Ohmeda Entropy sensor cable connects the Entropy sensor to the M-ENTROPY module both mechanically and electrically.
Calculated parameters are:
- Response Entropy, RE (range 0-100), continuous processed variable for fast detection of activation of facial muscles, i.e. FFMG.
- State Entropy, SE (range 0-91), continuous processed variable calculated from the EEG. SE is . designed to be sensitive to the hypnotic effect of anesthetic drugs in the brain.
- . Burst Suppression Ratio, BSR (range=0-100%), the percentage of epochs in the past 60 seconds in which the EEG signal is considered suppressed.
All the calculated parameters can be selected on the display, and trended. The raw EEG signal can be displayed from one of the two monitored channels. The waveform size, color and sweep speed can be adjusted. Alarms for Entropy are taken care of by the host monitor and follow the user interface for alarms in Datex-Ohmeda S/S patient monitors. There are auditory and visual alarms and user adjustable limits for Entropy variables. The default is OFF, because the device does not provide information to be used for treatment or therapy.
The provided text describes a medical device, the Datex-Ohmeda S/5 Entropy Module, and its intended use, but it does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria in the format requested.
The document is a Premarket Notification 510(k) Summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria. It mentions non-clinical testing for compliance with safety standards and software validation, but not clinical performance data against specific metrics.
Therefore, I cannot provide the requested table and information based on the provided text. The document states that the device "complies with the safety standards below and is therefore safe and effective for the intended use" and lists several non-clinical standards and guidelines with which it complies. It concludes that "there are no new questions of safety and effectiveness... as compared to the predicate device." This indicates a different type of evaluation process focused on regulatory compliance and equivalence rather than a clinical performance study with predefined acceptance criteria.
§ 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).