(26 days)
The Aspect EEG Monitors with BIS are intended to monitor the state of the brain by data acquisition of EEG signals in the intensive care unit, operating room and for clinical research.
The Bispectral Index (BIS), a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents.
The Aspect Medical Systems, Inc. EEG Monitors, Models A-1000 and A-1050 with the processed parameter BIS, (hereafter referred to as the Aspect EBG Monitors with BIS) are microprocessor-based, up to 4 channel EEG monitors designed for use in the OR, ICU and for clinical research.
They acquire and display real-time EEG waveforms, as well as process the real time EEG data using digital signal processing techniques including the Fast Fourier Transform technique, and display the processed EEG data in several different formats. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal in order to provide easier pattern recognition of changes over time during the recording.
The system configuration includes a monitor, digital signal converter (DSC), optional printer, cables and electrodes.
The EEG Monitors with BIS conform to UL 544, CSA 22.2 no. 125 Risk Class 3, IEC 601-1. They also meet electromagnetic interference specifications outlined in IEC 801-2,3,4,5.
The Aspect EEG Monitors with BIS consist of two main components:
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- Monitor
- Digital Signal Converter (DSC) - 4 channel maximum
A-1000 - 2,4 channel DSC A-1050 - up to 2 channel DSC
Monitors
The monitors are microprocessor-based, and provide signal processing and display capabilities, displaying up to 4 channels of real time (i.e. "raw") EEG data as well as computing and displaying processed EEG parameters (examples of some processed parameters are listed below). They also display trend plots of processed EEG parameters in real time.
The front panel is configured with a large display screen, an index display board composed of a numeric index display and an alphanumeric index label display. There are a number of soft and hard keys, such as Set-up, Print, Alarm Limits, Trend, EEG. CSA+. DSA+. Review and Event.
The monitors contain the processors for processing the EEG data, calculating the variables and displaying the waveforms and variables.
The monitors consists of a PC-based CPU, an IPU and an FPU. The latter two are Digital Signal Processing subsystems for EEG processing.
The provided document does not contain information regarding acceptance criteria and a study that proves the device meets the acceptance criteria. The document is a 510(k) summary for the Aspect Medical Systems, Inc. EEG Monitors, Models A-1000 and A-1050, which primarily describes the device, its components, and its intended use. It also includes the FDA's substantial equivalence letter.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers' improvement with AI vs. without AI assistance.
- If standalone performance was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document mentions "Bispectral Index (BIS) Monitoring Allows Faster Emergence and Improved Recovery From Propofol/Alfentanil/N2O Anesthesia. In preparation for Anesthesiology," but this is a reference to a publication in preparation and does not detail a specific study proving acceptance criteria for the device itself within this submission.
§ 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).