(70 days)
The Aspect A-2000 EEG Monitor with BIS is 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 BIS, a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents.
The Aspect A-2000 Monitor dimensions are 7 inches wide x 6.8 inches high x 4 inches deep. The active display area is 3.4 inches high x 4.5 inches wide, and displays Raw EEG waveforms, Density Modulated Spectral Array (DSA) (includes spectral edge frequency), Trend plots of processed EEG parameters in real time, Current BIS number, Signal quality and EMG indicators, and Suppression Ratio. The Aspect A-2000 Monitor performs automatic self tests upon power up to ensure that the monitor and its components are functioning properly. A quick test of the DSC-2 is conducted upon first detection of the DSC-2. In addition, comprehensive self tests can be initiated manually from the service menu. Results are reported on the display, and printed automatically if a printer is connected.
The provided documentation for the Aspect A-2000 EEG Monitor with BIS does not contain a specific table of acceptance criteria or a detailed study report demonstrating the device's performance against such criteria in the format requested.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Aspect Medical Systems EEG Monitor, Model A-1050 with BIS) through a comparison of technological characteristics. It mentions that "The following tests have been conducted: software, environmental, mechanical and electrical testing," and that "The Reviewer Guidance for Premarket Notification Submissions (1993) was followed... and all test results are submitted in Section (1)(I)(II)". However, these test results or a summary of them, including specific acceptance criteria and performance data, are not provided in the text.
The information primarily discusses:
- Device Description and Intended Use: The purpose of the A-2000 EEG Monitor with BIS is to monitor brain state by acquiring EEG signals and to aid in monitoring anesthetic effects using the BIS variable.
- Predicate Device: Aspect Medical Systems EEG Monitor, Model A-1050 with BIS.
- Technological Similarities and Minor Differences: Between the A-2000 and A-1050, covering areas like basic functions, hardware, software designs, signal flow, self-test capabilities, alarms, DSC-2, trended variables, and data sampling rate.
- References to a Clinical Study: A single clinical study is cited (Gan TJ et al., 1997) to support the use of BIS monitoring in anesthesia for faster emergence and improved recovery. However, this study is not presented as the primary study to meet acceptance criteria for the A-2000 device itself, but rather as evidence for the utility of the BIS parameter in general which the A-2000 also measures.
Based on the provided text, I cannot complete the requested information regarding acceptance criteria and performance with specific numerical details. The document states that tests were conducted and results submitted elsewhere, but those details are not included.
However, I can extract the following limited information:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text. The document refers to "The Reviewer Guidance for Premarket Notification Submissions (1993)" being followed, implying adherence to general regulatory guidance for EEG monitors. Specific quantitative criteria for device performance (e.g., accuracy, precision) are not listed.
- Reported Device Performance:
- The document implies that the device met the unstated criteria, as it concludes: "Aspect Medical Systems believes the A-2000 EEG Monitor with BIS is substantially equivalent to the Aspect A-1050 EEG Monitor with BIS, and is safe for its intended use."
- Details on the performance results (e.g., specific accuracy metrics, error rates) from the software, environmental, mechanical, and electrical tests are not provided in the text.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any internal device testing.
- Data Provenance: Not specified for any internal device testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- No information provided regarding experts for establishing ground truth for device performance testing.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- No information provided regarding any adjudication method.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study is mentioned for the device itself. The cited clinical study (Gan TJ et al., 1997) is a clinical trial on the effects of BIS monitoring on patient outcomes, not a comparative effectiveness study of the device's diagnostic performance involving human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device (A-2000 EEG Monitor with BIS) is inherently a standalone device for processing EEG signals and displaying a BIS number. Its "performance" would relate to the accuracy of its signal acquisition, processing, and display, which were presumably assessed during the "software, environmental, mechanical and electrical testing." However, detailed results of this standalone performance are not provided. The device is not an AI or diagnostic algorithm in the modern sense; it's a physiological monitor.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the device's internal performance tests (software, electrical, etc.), the ground truth would likely be established through engineering specifications, known signal inputs, and controlled environmental conditions. However, this is not explicitly detailed.
- For the clinical utility of the BIS parameter itself (as referenced by the Gan TJ et al. study), the ground truth relates to patient outcomes (e.g., emergence time, recovery quality), which is "outcomes data."
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The sample size for the training set
- No information provided. The A-2000 monitor is a physiological monitor, not a machine learning algorithm that typically requires a 'training set' in the conventional sense of AI. Its algorithms (like BIS calculation) would have been developed and validated through scientific research, not a specific training set in the context of this 510(k) submission.
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How the ground truth for the training set was established
- Not applicable as no training set (in the AI/ML sense) is described. The underlying algorithms for BIS would have been developed based on extensive physiological and clinical research correlating EEG patterns with states of consciousness/anesthesia, with ground truth established through clinical observations, expert assessment, and patient responses.
§ 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).