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The Sedline System is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents.

Sedline is an EEG monitor designed for use in the OR, ICU, EEG laboratory and for clinical research. It provides the ability to acquire and display real-time EEG waveforms, process the real time EEG data using digital signal processing techniques, display the processed EEG data in several different formats, and archive the real-time or processed EEG data for future review. The Sedline System consists of five components, the monitor, PSI algorithm, amplifier, patient cable and PSArray2 EEG Electrode Set. The device performs automatic self tests upon power up to ensure that the monitor and its components are functioning properly.

This 510(k) summary for the Physiometrix Sedline with Frontal PSI does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The provided document focuses on describing the device, comparing it to a predicate device, and outlining general testing (software, mechanical, electrical validation testing, and EMC testing) performed.

Therefore, I cannot provide the requested information based only on the input text. The information regarding acceptance criteria, specific device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, or MRMC studies is not present in the provided document.

The document states:

• Test Results: "The following tests have been conducted in order to verify and validate the device: software, mechanical and electrical validation testing and EMC testing." (Page 2)
• Standards: "The PSA4000 [predicate device] has been testing in accordance with the following standards. UL 2601, CSA 22.2 No. 601-1, IEC 601-1, IEC 601-2-26, FDA Reviewer Guidance for Premarket Notification Submissions, Section 7, Electromagnetic Compatibility dated November 1993." (Page 2)

This indicates that the device underwent general validation and verification testing according to relevant safety and performance standards for electroencephalographs and electromagnetic compatibility. However, it does not specify acceptance criteria for the "Patient State Index (PSI)" or provide performance results against such criteria.

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