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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.

2. Sample Size Used for the Test Set and the Data Provenance:

• Non-clinical bench tests (EEG, ECG, Actigraph comparison): The sample size is not explicitly stated as 'n=X' but implies a sufficient number of measurements were taken from the X-Series and predicate devices to compare their performance in a jig and with an oscilloscope/signal generator.
• Biocompatibility: The specific number of items/animals per test is mentioned in the results (e.g., "all the animals," "all test animals").
  • Cytotoxicity: Mammalian cell cultures (mouse fibroblast L929).
  • Sensitization: Albino guinea pigs.
  • Irritation: New Zealand White rabbits.
• Clinical tests (for ages 6+):
  • Sample size: Seven children aged 6-8 and seven adults.
  • Data provenance: "A subset of data from a research study was analyzed." This suggests the data was retrospective and likely collected in a clinical research environment (Country of origin not specified, but likely USA given the FDA submission).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• Non-clinical tests: The document implies standard laboratory testing procedures and comparisons to the predicate, overseen by qualified personnel. No specific "experts" for ground truth establishment are mentioned as the tests rely on objective measurements and established standards.
• Clinical tests (for ages 6+): The document states that the acquired EEG recordings "could be further examined in third-party software" by a Physician. While a physician would interpret the EEG, their role in establishing "ground truth" for the device's acquisition capabilities (the focus of this study) is not explicitly detailed. The acceptance criteria here are about the ability to acquire appropriate EEG recordings and data quality equivalence, which are evaluated directly from the device's output. The "ground truth" for this aspect is the objective quality of the signals themselves, compared between subject groups.

4. Adjudication Method for the Test Set:

• No formal adjudication method (like 2+1 or 3+1) is mentioned for any of the studies.
• The non-clinical tests rely on objective measurement against defined specifications or predicate device performance.
• The clinical study for children's EEG acquisition focused on the presence of "appropriate EEG recordings" and data quality equivalence, which would likely be assessed by comparing signal characteristics.

5. 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 was done.
• The X-Series System is a data acquisition device; it explicitly states, "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." It is not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done:

• Not applicable. This device is purely for data acquisition and display, to be interpreted by a physician using separate (third-party) software. There is no algorithm providing diagnostic or analytical output within the X-Series System itself.

7. The Type of Ground Truth Used:

• Non-clinical/Bench tests: Objective measurements (e.g., signal generator output, oscilloscope readings, defined angles for actigraph, standard test methods for biocompatibility and cleaning). The comparison to the predicate device serves as a de facto "ground truth" for performance equivalence where applicable.
• Clinical tests (for ages 6+): The "ground truth" for this specific study was the presence of "appropriate EEG recordings" and subjectively assessed "equivalent data quality" for the acquired signals between age groups. This relies on the qualitative assessment of electrical signal characteristics typically reviewed by trained professionals.

8. The Sample Size for the Training Set:

• Not explicitly stated, nor is a dedicated "training set" relevant for this device. The X-Series System is a data acquisition device, not a machine learning model that requires a training set. The clinical study for ages 6+ was a validation of its acquisition capabilities, not for training an algorithm.

9. How the Ground Truth for the Training Set was Established:

• Not applicable, as no training set was used for a machine learning algorithm.

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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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