(185 days)
The Geodesic EEG Mobile 100 (GEM 100) is intended to measure and record the electrical activity of the patient's brain. It can be used on adults, children, and infants.
The Geodesic EEG Mobile 100 (GEM 100) is a digital electroencephalograph system (EEG). It consists of an amplifier, two adapters, central processing unit, software, electrodes, isolation transformer, and components of a standard personal computer (monitor, keyboard, and mouse). Integral components allow wireless communication.
The GEM 100 has 4 configurations. These are based on the type of EEG electrodes that will be used and the environment for use. The Neurotravel software is used to acquire, record, and archive the data from all 4 configurations. These configurations are:
- Ambulatory EEG only .
- Ambulatory EEG with conventional electrodes and physiological sensors ●
- Stationary (in-clinic) EEG only .
- Stationary (in-clinic) EEG with conventional electrodes and physiological sensors .
The GEM 100 EEG Amplifier is used with all configurations, but the other components vary depending on the requirements of the patient and physician. Accessories that can be used with the GEM 100 include: Sensor Kit for SpO2, LTM Net Support Kit, Video EEG, photic stimulator, TTL patient event switch, laser or inkjet printer, mobile cart, and ambulatory pouch.
The GEM 100 operates like other digital electroencephalographs. It can run on mains power or on battery power. Data can be recorded to a CompactFlash card or to the system computer. Data can be transmitted by USB connection or by Bluetooth or can be transferred from the Compact Flash card to the system computer.
This submission is for a medical device (Geodesic EEG Mobile 100), which measures and records the electrical activity of the brain. The provided text does not contain acceptance criteria for device performance, nor does it detail a study proving the device meets performance criteria. The submission focuses on substantial equivalence to a predicate device and non-clinical safety/electrical testing.
Here's a breakdown of what is and isn't present in the provided document, in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document describes the device, its intended use, and compares its features to a predicate device. It mentions "non-clinical testing" for safety and software verification/validation, but does not provide specific performance metrics or acceptance criteria for those tests.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not available. The document explicitly states: "No clinical testing was submitted." Therefore, there is no test set of patient data, no sample size, and no data provenance information.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable/Not available. As no clinical testing was submitted, there was no need for experts to establish ground truth from patient data.
4. Adjudication Method for the Test Set
Not applicable/Not available. No clinical testing, thus no adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not available. The document states "No clinical testing was submitted," which means no MRMC study was conducted or provided in this submission. Therefore, there is no effect size of human reader improvement with or without AI assistance. (Note: This device is an EEG recording system, not an AI-driven diagnostic tool in the sense of image analysis, so an MRMC study comparing human reader performance on interpretations would likely be outside its scope anyway unless it involved an AI interpretation component, which is not indicated here).
6. Standalone (Algorithm Only) Performance Study
Not available. The device is an EEG recording system. Its primary function is data acquisition. While it contains software, the submission does not describe it as having a standalone "algorithm" for diagnostic interpretation or a study to evaluate its performance independently of human interpretation. "No clinical testing was submitted."
7. Type of Ground Truth Used
Not applicable/Not available. Since no clinical testing was submitted, no ground truth based on patient outcomes, pathology, or expert consensus was established for the purpose of validating the device's diagnostic performance. The device's "performance" in this submission is related to its electrical safety, software functionality, and ability to acquire EEG signals, which are assessed through engineering and non-clinical tests.
8. Sample Size for the Training Set
Not applicable/Not available. As no machine learning or AI algorithm development for diagnostic interpretation is described, there is no concept of a "training set" of patient data.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not available. As there's no training set, there's no ground truth establishment for it.
Summary of what the document does indicate about testing:
The "Non-clinical Testing" section states:
- Extensive testing was conducted.
- The product passed general testing to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-26 (international standards for medical electrical equipment safety, essential performance, and electromagnetic compatibility for electroencephalographs).
- Additional testing verified long-term monitoring capabilities and use of an SpO2 sensor.
- Software verification and validation activities were successfully completed.
These describe safety and functional performance tests against recognized standards, not clinical performance metrics or diagnostic accuracy against a ground truth from patient data.
§ 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).