(279 days)
The GE Healthcare 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 Entropy algorithm in the host monitor calculates the spectral entropies, Response Entropy (RE) and State Entropy (SE), which 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.
GE Healthcare Entropy Module, E-ENTROPY is a single-width plug-in parameter module for GE Healthcare modular monitoring systems. EEG signals reflect the underlying state of brain activity. As a person falls asleep or is anesthetized, the brain function (activity) starts to decrease and becomes more orderly and regular. EEG changes from irregular to more regular patterns when anesthesia deepens. Similarly, frontal EMG quiets down as the deeper parts of the brain are increasingly saturated with anesthetics. Entropy measurement is based on processing of raw EEG and FEMG signals by using the Entropy algorithm, a GE application of Spectral Entropy. The algorithm is published: Viertiö-Oja H et al. Description of the Entropy algorithm as applied in the Datex-Ohmeda S/5 Entropy Module. (Acta Anaesthesiologica Scandinavica 2004; Volume 48: Issue 2:154-161, 2004). Entropy measures irregularity of EEG and FEMG. The GE Entropy measurement devices are responsible for EEG and FEMG signal acquisition, amplification, filtering and digitization and electrode impedance measurement. The Entropy algorithm in the host monitor calculates the spectral entropies, Response Entropy (RE) and State Entropy (SE). The Entropy Module, E-ENTROPY-01 uses the identical Entropy algorithm and accessories as the predicate device, S/5TM Entropy Module, E-ENTROPY-00 (K061907).
Here's a breakdown of the acceptance criteria and study information for the GE Healthcare Entropy Module, E-ENTROPY-01, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" for performance in a quantitative way for the new device, other than demonstrating substantial equivalence to the predicate. Instead, it details the technical specifications of both the predicate and proposed device, and notes whether they are identical or equivalent. The "acceptance criteria" here are implicitly the specifications of the predicate device, or updated standards where applicable.
| Feature / Specification | Predicate Device (E-ENTROPY-00) Performance | Proposed Device (E-ENTROPY-01) Performance | Discussion of Differences / Acceptance Outcome |
|---|---|---|---|
| Indications for Use | Same as proposed device | Indicated for adult & pediatric patients > 2 years for EEG/FEMG monitoring as adjunct; aids in monitoring anesthetic effects in adults, potentially reducing anesthetic use & speeding emergence. Prescription use. | Equivalent (Clarification that algorithm resides in monitor, no impact on SE) |
| Patient Age Limit | Adult & pediatric patients > 2 years | Adult & pediatric patients > 2 years | Identical |
| General Safety Standards | IEC 60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995, EN 60601-1:1990 + A1:1993 + A2:1995 + A13:1996, CAN/CSA-C22.2 No. 601-M90 + S1:1194 + Amdt 2:1998, UL 2601-1:1997, IEC 60601-2-26:2002, EN 60601-2-26:2002, IEC 60601-1-2:2001, EN 60601-1-2:2001, IEC 60601-1-4:1996 + Amd 1:1999, EN 60601-1-4:1996 + A1:1999 | IEC 60601-1:1988 + Amdt 1:1991 + Amd 2:1995, EN 60601-1:1990 + A1:1993 + A2:1995 + A13:1996, CAN/CSA-C22.2 No. 601-M90 + S1:1194 + Amdt 2:1998, UL 60601-1:2003, IEC 60601-2-26:2002, EN 60601-2-26:2002, IEC 60601-1-2:2001 + A1:2004, EN 60601-1-2:2001 + A1:2006, IEC 60601-1-4:1996 + A1:1999, EN 60601-1-4:1996 + A1:1999 | Equivalent (Updated standards used for proposed device, no impact on SE) |
| Patient Monitor Compatibility | Datex-Ohmeda S/5™ Anesthesia Monitor (K092680), Datex-Ohmeda S/5™ Compact Anesthesia Monitor (K061185) | Datex-Ohmeda S/5™ Anesthesia Monitor (K092680), Datex-Ohmeda S/5™ Compact Anesthesia Monitor (K061185), GE Healthcare CARESCAPE™ B850 Patient monitor (K131414), GE Healthcare CARESCAPE™ B650 Patient monitor (K131223), GE Healthcare CARESCAPE™ B450 Patient monitor (K132533), GE Healthcare B40 Patient monitor (K133576) | Equivalent (New monitors added since predicate submission) |
| Number of EEG Channels | 1 channel of raw EEG | 1 channel of raw EEG | Identical |
| EEG Measurement Mode | Referential | Referential | Identical |
| Input Dynamic Range | ±400 uV | ±500 uV | Equivalent (Slightly larger range, no impact on SE) |
| Input Offset | ±300 mV | ±300 mV | Identical |
| Frequency Range | 0.5 to 118 Hz | 0.5 to > 100 Hz | Equivalent (Algorithm uses frequencies within both specifications, no impact on SE) |
| Noise | 1 MΩ at 10 Hz | > 400 KΩ @ 10 Hz | Substantially equivalent (Per IEC 60601-2-26:2012, 400 kΩ is still significantly higher than max skin-electrode impedance for reliable measurement, no impact on SE) |
| Common Mode Rejection Ratio | > 100 dB at 50 Hz | > 90 dB @ 50 Hz | Substantially equivalent (Harmonized with IEC 60601-2-26 3rd ed., no impact on SE) |
| Defibrillation Protection | 3000V | 3000V | Identical |
| Sampling Frequency | 400 Hz (1600 Hz with oversampling) | 400 Hz (1600 Hz with oversampling) | Identical |
| Degree of Protection against Electrical Shock | CF, defibrillation-proof | CF, defibrillation-proof | Identical |
| Impedance Measurement Frequency | 75 Hz | 75 Hz | Identical |
| Impedance Measurement Range | 1 to 30 kΩ | 1 to 20 kΩ | Equivalent (Decision limit for "check sensor" is 7.5 kΩ, well within both specs, no impact on SE) |
| Impedance Measurement Resolution | 0.1 kΩ | 0.1 kΩ | Identical |
| Impedance Measurement Accuracy | ±1 kΩ or ±10% | ±1 kΩ or ±10% | Identical |
| Leads of Detection | Continuous | Continuous | Identical |
| Start of Impedance Measurement | Manual / Automatic | Manual / Automatic | Identical |
| Compatible Patient Cable | GE Entropy Cable M1050784, K062580 | GE Entropy Cable M1050784, K062580 | Identical |
| Compatible Sensors | GE Entropy Sensor M1038681, K082540; Entropy EasyFit Sensor M1174413, K103129 | GE Entropy Sensor M1038681, K082540; Entropy EasyFit Sensor M1174413, K103129 | Identical |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "No additional clinical tests were performed for proposed ENTROPY MODULE, E-ENTROPY."
Therefore, there is no distinct "test set" or data provenance information provided from new clinical studies for this submission, as the device's substantial equivalence relies on its technical specifications matching or being equivalent to the predicate device and compliance with recognized standards. The study that "proves the device meets the acceptance criteria" is primarily the non-clinical testing detailed below, demonstrating the device's adherence to relevant standards and its technical similarity to the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable, as no new clinical or comparative performance studies with human readers and ground truth were conducted for this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable, as no new clinical or comparative performance studies were conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an Electroencephalograph (EEG) module that processes signals to derive "Entropy" values (Response Entropy and State Entropy). It is not an AI-assisted diagnostic tool that human readers would use in a comparative effectiveness study in the typical sense of MRMC. The device provides physiological parameters to aid medical personnel.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The device is an "Entropy Module" which acquires EEG/FEMG signals. The "Entropy algorithm in the host monitor calculates the spectral entropies." While the algorithm itself operates "standalone" in calculating the Entropy values, the overall system is designed for use by "qualified medical personnel" as an adjunct to other physiological parameters. The document doesn't describe an isolated performance study of just the algorithm's output quality against a gold standard without the full device hardware context or human interpretation, beyond validating its technical specifications. The provided document doesn't detail a standalone study of the algorithm's diagnostic accuracy or effectiveness.
7. The Type of Ground Truth Used
For the purpose of this 510(k), the "ground truth" for the algorithm's performance is implicitly established by its equivalence to the predicate device's algorithm, which is published (Viertiö-Oja H et al., Acta Anaesthesiologica Scandinavica 2004). The "ground truth" for the device's safety and effectiveness is its adherence to recognized medical device standards (IEC, EN, UL, CAN/CSA) and its equivalence to a legally marketed predicate device.
8. The Sample Size for the Training Set
Not applicable, as this is primarily a hardware device with an established algorithm (from the predicate). The document does not describe the development or training of a new AI algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no new training set or new AI algorithm development is described in this submission. The algorithm itself is stated to be identical to the predicate: "The Entropy Module, E-ENTROPY-01 uses the identical Entropy algorithm and accessories as the predicate device, S/5TM Entropy Module, E-ENTROPY-00 (K061907)." The algorithm's prior validation and publication (Viertiö-Oja H et al.) serves as its original basis.
Summary of Device Meeting Acceptance Criteria:
The GE Healthcare Entropy Module, E-ENTROPY-01, meets its acceptance criteria primarily through:
- Substantial Equivalence: Demonstrating that it is "as safe, as effective, and performance is substantially equivalent to the predicate device" (Datex-Ohmeda S/5™ Entropy Module, E-ENTROPY-00, K061907) based on technical specification comparison.
- Adherence to Standards: Compliance with numerous national and international medical electrical equipment safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, etc.).
- Non-Clinical Testing: In-house system testing, usability validation, and software testing (DOC1221813 In-House Verification Report, DOC1208044 Usability Validation Plan, DOC1261218 Usability Testing Report, DOC1223430 E-ENTROPY-01 Verification Report) confirmed compliance with defined acceptance criteria in the verification plan (DOC1019758).
§ 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).