(285 days)
The Geodesic EEG System™ Series 100 products are intended to measure and record The Clectrical activity of the patient's brain. They can be used on adults, children, and infants.
The Geodesic EEG System™ Series 100 products, also known as the GES Series 100, are digital electroencephalography systems (EEG) that can accommodate up to 256 electrodes. The GES Series 100 is computer controlled and capable of acquiring, storing, and displaying data. It includes electrodes, amplifiers, a central processing unit, and software. The GES Series 100 uses some components from the previously submitted and cleared Geodesic EEG System™ Model 200. It blends these with components from another manufacturer. The combined product is new and has not been previously submitted to FDA.
The GES Series 100 products are composed of the following components. The Geodesic Sensor Net® is a dense array of scalp electrodes designed to allow rapid application in an even distribution across the head and is the preferred electrode system. Standard EEG electrodes and cap-type electrodes purchased from other vendors may also be used. The Neurotravel WIDE consists of multiple amplifiers for physiological signals that are fully software controlled. The central processing unit can be either Mac based or PC based. Mac based systems use the proprietary Net Station® software package to control acquisition of data, storage of digital data, and manipulation of data for review. PC based systems use the Neurotravel Win software package to control similar system features. Neither software package performs any diagnosis. Additional components of the system are an articulated arm with extended cable, isolation transformer, rack system, various cables, standard components of personal computer (monitor, keyboard, and mouse), photic stimulator, video EEG, electrolyte solution, and disinfectant.
The provided document describes the Geodesic EEG System™ Series 100 (GES Series 100), an electroencephalography system. It details its components, intended use, and technological characteristics compared to a predicate device. However, it explicitly states that "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This means that the document does not contain information on acceptance criteria or a study that proves the device meets specific performance criteria.
Therefore, I cannot provide the requested table or answer the specific questions regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Geodesic EEG System™ Model 200, K012079) based on technological characteristics and compliance with general safety and electromagnetic compatibility standards, rather than clinical performance outcomes.
§ 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).