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The X-Series System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, transmit, display and store physiological signals from patients ages 6 and older. The X-Series system requires operation by a trained technician. The X-Series System acquires, transmits, displays and stores electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), and accelerometer signals. The X-Series System only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.

The X-Series System is indicated for acquiring, transmitting, displaying and storing physiological data in patients. It can be used with ambulatory patients in the home, health care facility, or clinical research environment. The X-Series system requires operation by a trained technician. The X-Series System.is comprised the X10 and X24 Headsets and accessories, Synapse Cream, X-Series Basic Software and BT receiving unit. The X-Series Basic Software is also compatible with the Models X4-E, and X4-M (K130013) when used in wireless mode. The X-Series System combines hardware, firmware and software to acquire physiological signals. It acquires physiological data through a battery powered headset worn by the patient and provides a flexible platform for applying sensors using synapse cream and acquiring signals from multiple locations on the head or body, transmitting and recording the signals and providing visual indications to ensure high quality data are obtained. Model X24 provides for acquisition of twenty channels of electroencephalography (EEG) and four optional channels connected to two sensors via a dual-lead connector. Model X10 provides for acquisition of nine channels of electroencephalography (EEG) and an optional channel connected to two sensors via a dual-lead connector. Both models measure movement and position measured via a 3-D accelerometer. The device is designed so it can be affixed by a technician and displays the signals via a wireless connection during acquisition. The X-Series Basic software monitors signal quality to ensure that the sensors are properly applied and that high quality signals are being acquired. The X-Series Basic software provides a means to: a) initiate a study and track patient information, b) acquire and wirelessly transmit signals from the device, c) visually inspect the signal quality. The acquired signals are saved in a universal data format (European Data Format Plus, EDF+) that is intended to be analyzed by a Physician using FDA cleared third party software, i.e. Persyst Software (K011397).

This document describes the X-Series System, an electroencephalograph device for acquiring, transmitting, displaying, and storing physiological data. The submission focuses on demonstrating substantial equivalence to a predicate device (K130013 X4 System) through non-clinical and limited clinical testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document leverages comparison to a predicate device and adherence to recognized standards as its primary acceptance criteria. Performance metrics are largely presented as being equivalent to the predicate.

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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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