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The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient's brain obtained by placing electrodes on the patient scalp.

The ElectroTek is intended to be used for such studies as electroencephelogram (EEG) and video EEG recording to aid in diagnosis. The ElectroTek does not draw any diagnostic conclusions.

The ElectroTek is a portable EEG system designed to improve the overall EEG test experience for the patient, the electroneurodiagnostic technician running the EEG test, and the physician that reads the EEG results. The ElectroTek is optimized for fast setup with easy and intuitive use, resulting in improvements in overall usability at a lower total cost of ownership for an EEG system. The ElectroTek is designed to push data to the MobileMedTek Portal for secure archived data storage and remote viewing over the web by the reading physician. The ElectroTek's is used for routine EEG studies in outpatient clinic and small/medium hospital settings. The ElectroTek is also designed to be used in long term monitoring (LTM) conditions exceeding 24 hours per study.
The ElectroTek EEG System is comprised of the case, device, custom hardware, the computing device, control software, firmware, peripheral devices, cables, and disposables. The peripheral devices include a Photic Stimulator for inducing seizure activity and a manually activated pushbutton Event Marker. Three primary Cables supplied by MobileMedTek as part of the ElectroTek include a Peripheral Cable that connects the Photic Stimulator to the ElectroTek Custom Hardware, the Event Marker cable that includes the handheld pushbutton and connects to the ElectroTek Custom Hardware, and a Patient Cable that includes a plug-in "yoke" box and connects to the ElectroTek Custom Hardware. Consumable Cables that will be supplied by MobileMedTek include four different electrode cables (the Sagittal (aka, "Midline") cable, the Parasagittal cable, the Transverse cable, and Individual cables. These cables are intended for re-use. The only single-use Disposables planned for the ElectroTek are the electrode cups that snap into the four consumable Cables and connect to the patient's head.

The provided document is a 510(k) premarket notification for the ElectroTek electroencephalographic system. It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study with detailed acceptance criteria and results from a clinical trial.

Therefore, the information required to answer your request (acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC study, standalone performance, ground truth establishment) is not present in the provided text. The document is a regulatory submission for premarket clearance based on equivalence, not a summary of a performance validation study against specific acceptance criteria.

The document states:

• "The ElectroTek does not draw any diagnostic conclusions." This indicates it's a data acquisition and display device, not an AI-powered diagnostic tool that would typically undergo rigorous performance validation against clinical ground truth.
• "The MobileMedTek ElectroTek meets the functional claims and intended use as described in the product labeling. The ElectroTek EEG device is substantially equivalent to the predicate devices." This is the ultimate "conclusion" of the submission, demonstrating that it functions similarly to existing, cleared devices.

Without information specific to an AI/ML component or a performance study, it's impossible to fill in the requested table and details. The tables present a comparison of technical characteristics to predicate devices (e.g., number of channels, CMRR, noise, input impedance, filter settings, A/D conversion, sampling rate), not performance metrics against acceptance criteria for diagnostic capability.

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