(477 days)
Indication for use for GE Entropy Sensor (REF M1123614): This GE Entropy Sensor is intended to be used for adults with GE Entropy measurement devices to enable recording of physiological signals (such as EEG). To connect this sensor to the measurement device, use the GE Entropy Cable. Indication for use for GE Entropy Cable (REF M1050784): Use the sensor cable only with GE Entropy measurement devices together with GE Entropy Sensor or Entropy Sensor.
The GE Entropy Sensor is a sensor assembly with three (3) pre-gelled EEG electrodes. The GE Entropy Sensor is applied to the skin of the patient to record electrophysiological (such as EEG and FEMG) signals. It is a low impedance, single patient use, non-sterile disposable electrode sensor that is designed for application to the frontal/temporal area. The GE Entropy Sensor is designed to provide ease of use and electrode placement accuracy. It is used in conjunction with the M-ENTROPY and E-ENTROPY module. The Entropy sensor collects EEG and facial EMG signals from these areas, and the differential signal from the temple to the center of the forehead is used to calculate the Entropy variables. To obtain the lowest possible skin impedance, a preparation pad is used to lightly abrade the skin to remove the insulating outer layer. One preparation pad is included with each sensor. The GE Entropy Sensor is individually packaged inside a moisture tight foil pouch. One preparation pad is included inside the same foil pouch. A selling box for the GE Entropy Sensor contains 25 sensor pouches and an instruction insert. The GE Entropy Cable is a reusable cable that connects the GE Entropy Sensor (REF M1123614) or Entropy Sensor (REF 8002858) to the M-ENTROPY or E-ENTROPY module both mechanically and electrically. The GE Entropy Sensor is connected directly to the sensor-end of the GE Entropy Cable and the device-end of the cable is connected directly to the M-ENTROPY or E-ENTROPY module. The GE Entropy Cable is individually packaged in a plastic bag together with an instruction insert.
This document describes the GE Entropy Sensor and Cable, which are accessories for EEG measurement devices. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel algorithm or performance study in the traditional sense.
Therefore, many of the requested categories (like AI performance, ground truth establishment for training, expert adjudication, MRMC studies) are not applicable to this type of submission. The "acceptance criteria" here refer to compliance with recognized standards and a demonstration of equivalent specifications and safety to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance / Compliance |
|---|---|---|
| Electrical Safety | FDA 21 CFR Part 898, § 898.12 (Performance standard for electrode lead wires and cables) | Assessed against and met. |
| EN 60601-1:2005 (General requirements for safety) | Assessed against and met. | |
| IEC 601-2-26:1994 (Particular requirements for electroencephalographs) | Assessed against and met. | |
| ANSI/AAMI EC12-2000 | Assessed against and met. | |
| ANSI/AAMI ES1:1993 | Assessed against and met. | |
| UL 2601-1 | Assessed against and met. | |
| CAN/CSA C22.2N0601.1 | Assessed against and met. | |
| IEC 664-1 (Insulation coordination) | Assessed against and met. | |
| ANSI/AAMI EC53-1995 (ECG cables and leadwires) | Assessed against and met. | |
| Biocompatibility | ISO 10993-1, -5, -10 (Biological evaluation of medical devices) | Assessed against and met. |
| Risk Management | ISO 14971:2000 (Application of risk management to medical devices) | Assessed against and met. |
| Labeling/Documentation | FDA /ODE Guidance for Content of Premarket Submission for Software Contained in Medical Devices, May 11, 2005 | Assessed against and met. |
| ISO 15223:2000 (Symbols for medical device labeling) | Assessed against and met. | |
| EN 980+A1+A2 (Graphical symbols for medical devices) | Assessed against and met. | |
| Functional Equivalence | 3 wet gel electrodes, conductivity, adhesion on the patient's forehead, plug interface, air clearances (for ESU/defibrillation safety) | Demonstrated similarity to predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
This submission is for medical device accessories (electrodes and cables), not an algorithm or diagnostic tool that uses patient data in a "test set" for performance evaluation in the typical sense. The testing performed involved technical validation and verification against engineering standards. Therefore, concepts like patient data provenance do not directly apply. The testing was conducted internally by GE Healthcare.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The ground truth for this type of submission is defined by compliance with established engineering and safety standards, not by expert interpretation of patient data.
4. Adjudication Method for the Test Set
Not applicable. There was no "test set" of patient data requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is not an AI or diagnostic imaging device that would typically undergo an MRMC study.
6. Standalone (Algorithm Only) Performance Study
No. This device is an accessory (sensor and cable) for existing medical equipment and does not contain a standalone algorithm.
7. Type of Ground Truth Used
The "ground truth" here is compliance with international and national recognized standards for electrical safety, biocompatibility, and functional specifications for medical devices of this type. This is demonstrated through various engineering tests and certifications.
8. Sample Size for the Training Set
Not applicable. This submission is for hardware medical device accessories and does not involve a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This submission does not involve a training set.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).