(89 days)
Zenith is an electroneurodiagnostic device that accepts, measures, and stores electrical activity of the brain via scalp and intracranial electroencephalography (EEG) signals, and, utilizing an integrated switch matrix, relays stimulation signals to the patient. It can obtain, display and store electrophysiological data from the central nervous system, generated either spontaneously or elicited by well-defined stimuli. The data is used to perform neurodiagnostic evaluations, including EEG and direct cortical stimulation. Zenith Cadwell acquisition software.
Zenith is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative testing on patients of all ages.
The Cadwell Zenith System is a high channel-count Electroencephalogram (EEG) system capable of cortical stimulation via the optional stimulator and built in switch matrix. The system is capable of acquiring, storing, and reviewing neurophysiological data and report generation. The Cadwell Zenith System can be configured in a portable or fixed room configuration. Carts are available for purchase with the system. The Cadwell Zenith System consists of one (1) or more Zenith amplifiers, an IOMAX Base Module, and an optional IOMAX Cortical Module. Additionally, a Patient Event Button, USB Photic Stimulator, and USB Footswitch can be purchased separately
The provided document is a 510(k) premarket notification summary for the Cadwell Zenith System, an electroencephalograph (EEG) device. It describes the device's technical specifications and how it compares to predicate devices, along with summaries of performance testing related to electrical safety, electromagnetic compatibility, and software validation.
However, the document does not contain information about "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-based diagnostic device. This document describes a traditional medical device (an EEG system) and its substantial equivalence to previously marketed devices. There is no mention of an AI component, an algorithm that generates diagnostic outputs, or any performance metrics like sensitivity, specificity, or AUC that would be associated with such a study.
Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving device performance using the provided text, as the necessary information for AI/algorithm performance validation is absent. The document focuses on hardware performance, safety standards compliance, and software validation for its core functionality as an EEG system, not on intelligent diagnostic performance.
§ 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).