(631 days)
The Datex-Ohmeda Entropy Module, E-Entropy and accessories are indicated for adult and pediatric patients older than 2 years within a hospital for monitoring the state of the brain by data acquisition of electroencephalograph (EEG) and frontal electromyograph (FEMG) signals. The spectral entropies, Response Entropy (RE) and State Entropy (SE), are processed EEG and FEMG variables. The Entropy measurement is to be used as an adjunct to other physiological parameters.
In adult patients, Response Entropy (RE) and State Entropy (SE) may be used as an aid in monitoring the effects of certain anesthetic agents, which may help the user titrate anesthetic drugs according to the individual needs of adult patients. Furthermore in adults, the use of Entropy parameters may be associated with a reduction of anesthetic use and faster emergence from anesthesia.
The Entropy module is indicated for use by qualified medical personnel only.
The Entropy Module, E-ENTROPY, is a single-width plug-in parameter module for Datex-Ohmeda modular perioperative monitors, the S/5 AM. E-ENTROPY is a module used to calculate parameters from electroencephalograph (EEG) and frontal electromyograph (FEMG) signals. The E-ENTROPY module provides two spectral entropy parameters State Entropy (SE) and Response Entropy (RE). The E-ENTROPY module uses the identical Entropy algorithm and accessories as the predicate device, E-ENTROPY (K050835). 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. 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 pass 60 seconds in which the EEG signal is considered suppressed.
The provided document, a 510(k) premarket notification summary, primarily focuses on demonstrating substantial equivalence to a predicate device for updated indications for use, rather than presenting a detailed study supporting specific device performance acceptance criteria. The submission states that the proposed modifications to the indications for use do not involve changes to the module's hardware, software, or accessories, and that the device uses the identical Entropy algorithm as the predicate device (K050835). Therefore, the information typically found in a study demonstrating performance against acceptance criteria for a new device is largely absent.
However, based on the information provided, we can infer some details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria or present a table of reported device performance in the way a clinical study report would. Instead, it justifies the expanded indications for use based on the existing device's proven technology and scientific literature.
- Acceptance Criteria (Inferred from context): The implicit acceptance criteria are that the device, with its unchanged hardware/software, continues to perform as safely and effectively as the predicate device (K050835) for the expanded indications (pediatric patients > 2 years, aiding in titrating anesthetic drugs, reducing anesthetic use, and enabling faster emergence from anesthesia in adults).
- Reported Device Performance: The document states that the Datex-Ohmeda S/5™ Entropy Module, E-ENTROPY uses the identical Entropy algorithm and accessories as the predicate device, E-ENTROPY (K050835). The calculated parameters are:
- Response Entropy (RE): range 0-100, continuous processed variable for fast detection of activation of facial muscles (FEMG).
- State Entropy (SE): range 0-91, continuous processed variable calculated from the EEG, sensitive to the hypnotic effect of anesthetic drugs.
- Burst Suppression Ratio (BSR): range 0-100%, percentage of epochs in the past 60 seconds where the EEG signal is suppressed.
The document asserts that the updated indications are "based on independent, peer-reviewed and published scientific articles in medical journals, as well as studies made internally at GE Healthcare." This implies that external research and internal studies provided the evidence for the efficacy related to the new claims, but the details of these studies are not provided in this 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance
This information is not explicitly stated in the provided 510(k) summary. The submission refers to "independent, peer-reviewed and published scientific articles in medical journals, as well as studies made internally at GE Healthcare" for the scientific justifications. The specific sample sizes, study designs (retrospective/prospective), and data provenance (e.g., country of origin) for these underlying studies are not detailed here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not explicitly stated in the provided document. As the submission relies on existing scientific literature and internal studies, the details of expert involvement in establishing ground truth for those studies are not available here.
4. Adjudication Method for the Test Set
This information is not explicitly stated in the provided document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done (and effect size)
This information is not explicitly stated in the provided document. The submission focuses on the device's technical characteristics being identical to the predicate and the justification for expanded indications based on existing literature.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
The device itself is an "algorithm only" component (an Entropy module calculating parameters from EEG/FEMG signals). The document states, "The F-F.NTROPY module uses the identical Entropy algorithm... as the predicate device." It describes the module's function to "calculate parameters" (RE, SE, BSR). Therefore, the device operates in a standalone manner to generate these parameters. However, the application of these parameters is "to be used as an adjunct to other physiological parameters" and "by qualified medical personnel only," implying a human-in-the-loop for interpretation and clinical decision-making. No separate "standalone performance study" of the algorithm independent of a human is detailed, as its core function is the calculation itself, which is already established by the predicate device.
7. The Type of Ground Truth Used
Based on the nature of the device (monitoring neurophysiological status and effects of anesthetic agents), the ground truth for the "scientific justifications" would likely involve:
- Clinical Outcomes/Physiological Correlates: For claims like "titrate anesthetic drugs according to the individual needs," "reduce the amount of certain hypnotic drugs," and "enable faster emergence from anesthesia," the ground truth would be established through clinical outcomes (e.g., patient awakening times, actual drug dosages administered, clinical assessment of depth of anesthesia) correlated with Entropy parameter readings.
- Expert Clinical Assessment/Consensus: The determination of "state of the brain" or "effects of certain anesthetic agents" would typically involve an expert's clinical judgment, potentially supported by other physiological monitors and patient responses.
- Pathology/Biomarkers: Unlikely to be the primary ground truth for this type of device, but could potentially be part of broader research into anesthetic mechanisms.
The document states these justifications come from "independent, peer-reviewed and published scientific articles in medical journals, as well as studies made internally at GE Healthcare," suggesting that the ground truth methods used in these underlying studies would be diverse and appropriate for clinical research in anesthesiology.
8. The Sample Size for the Training Set
This information is not applicable or not provided.
- It's "not applicable" in the context of this submission because the device's algorithm is identical to the predicate. The algorithm itself was already developed and validated with a "training set" for the predicate device (K050835). This submission is for expanded indications, not a new algorithm.
- If we consider the original development of the Entropy algorithm, the details of its training set would reside in the documentation for the predicate device (K050835), or the external peer-reviewed literature and internal GE Healthcare studies referenced. These specifics are not provided in this document.
9. How the Ground Truth for the Training Set Was Established
Similar to point 8, this information is not applicable or not provided in this specific 510(k) submission. The ground truth for the original algorithm development (i.e., for the predicate device) would have been established through clinical trials and expert correlation of EEG/FEMG signals with anesthetic depth and patient state. The precise methods would be detailed in the documentation for K050835 or the scientific literature that informed its development.
§ 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).