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The Datex-Ohmeda Entropy Module, E-ENTROPY and accessories are 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, Response Entropy (RE) and State Entropy (SE), 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 S/5TM Entropy Module, E-ENTROPY is used for acquiring and processing of raw EEG and FEMG signals. The Entropy algorithm processes the collected signals and yields two Entropy variables - state entropy (SE) and response entropy (RE) - and burst suppression ratio, in addition to one real-time EEG waveform channel. The variables may be used as an aid in monitoring the effects of certain anesthetic agents. Entropy is thus used to assess the adequacy of anesthesia status in relation to other standard physiological signs and monitoring modalities (HR, blood pressure, NMT, MAC etc.). The Datex-Ohmeda Entropy module, E-ENTROPY is a single-width plug-in parameter module for a Datex-Ohmeda modular monitoring system. The E-ENTROPY module uses the same Entropy algorithm and accessories as the predicate device, M-ENTROPY (K023459). Entropy monitoring is based on acquisition of raw EEG and FEMG signals and processing them by using the Entropy algorithm - a Datex-Ohmeda application of spectral entropy based on information theory. The E-Entropy Module may be used as an aid in monitoring the effects of certain anesthetic agents. Calculated parameters are: Response Entropy, RE (range 0-100), continuous processed variable for fast detection of activation of facial muscles, i.e. FEMG. 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/5 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 accessories are the same for the E-ENTROPY module and the predicate device, the M-ENTROPY (K023459). The Datex-Ohmeda 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 electrode 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 only with M-ENTROPY and E ENTROPY modules. The Datex-Ohmeda Entropy sensor cable connects the Entropy sensor to the ENTROPY module both mechanically and electrically.

The provided PMA (Premarket Approval) document for the Datex-Ohmeda S/5™ Entropy Module, E-ENTROPY and accessories (K050835) is a substantial equivalence claim to a predicate device (Datex-Ohmeda M-ENTROPY Module, K023459). It does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or clinical performance data typically found in a clinical study report.

The document explicitly states that the E-ENTROPY module is a "facelifted version" of the predicate M-ENTROPY module, with the "software and measurement hardware are the same as those of the predicate device (K023459)." Furthermore, it highlights "identical intended use and indications for use," "identical fundamental scientific technology," and the "same entropy calculation algorithm."

Therefore, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device through technological similarity, not on presenting novel performance data against pre-defined acceptance criteria for a new clinical study.

2. Sample Size Used for the Test Set and Data Provenance:

This information is not applicable/not available because no specific clinical test set data is presented to prove performance. The submission relies on the established performance of the predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable/not available as no specific clinical test set data or ground truth establishment is described for the E-ENTROPY module.

4. Adjudication Method for the Test Set:

This information is not applicable/not available as no specific clinical test set or adjudication process is described for the E-ENTROPY module.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable/not available. No MRMC study comparing human readers with and without AI assistance is mentioned. The device is for monitoring neurophysiological status, not for interpretation by human readers in a diagnostic setting like medical imaging.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This information is not explicitly detailed as a standalone study for the E-ENTROPY module. The document states that the "software and measurement hardware are the same as those of the predicate device" and that the "same entropy calculation algorithm" is used. It implies that the algorithm's performance was established with the predicate device. The submission describes non-clinical testing focused on safety and electrical compatibility standards (IEC, EN, CSA, UL, AAMI, ISO), and FDA guidance for EEG devices and software.

7. Type of Ground Truth Used:

This information is not applicable/not available as there is no mention of a new study using ground truth for the E-ENTROPY module's performance evaluation. The underlying technology's performance was presumably established with the predicate device.

8. Sample Size for the Training Set:

This information is not applicable/not available. As this is a 510(k) for a device largely identical to its predicate, there is no mention of retraining an AI algorithm or a new training set. The "entropy algorithm" is stated to be the "same."

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable/not available. Similar to the training set size, this information is not provided as the device is not presented as a newly trained AI model.

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