(81 days)
The Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482 is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.
The Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482 may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
The Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482 (BISx Module 91482) is an easy-to-use, slim, single module in the Spacelabs Medical family of Spacelabs Medical Ultraview System (Ultraview) modules. The BISx Module 91482 is a microprocessor based, two-channel EEG unit designed for use on adult and pediatric patients within a hospital or medical facility. Its system configuration includes the BISx Module 91482 with connectors for external serial data connections, a BISx pod, a patient interface cable, disposable sensors, and printer options. The BISx pod, patient interface cable and disposable sensors are manufactured by Aspect Medical Systems, and distributed by Spacelabs Medical for use with the BISx Module 91482, The Spacelabs Medical Ultraview monitor provides the display capabilities for the care provider.
The provided text describes the Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
The document is a 510(k) Premarket Notification summary focusing on the general safety and effectiveness, device description, and indications for use as part of the FDA approval process. It confirms substantial equivalence to existing devices but does not detail device performance studies or their results.
Therefore, I cannot populate the requested table or answer the specific questions about the study that proves the device meets acceptance criteria based solely on the provided text. The requested information, such as sample sizes, ground truth establishment, expert qualifications, and specific performance metrics, is not present in this document.
§ 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).