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The NEBA® Compact EEG 2R Mobile Headset) is intended to capture, amplify, and wirelessly transmit electrical brain activity for review by a trained medical professional using the CEEG2R recording software. The NEBA Headset comprises an electrode positioning system for placing single-use disposable electrodes on the head (Vermed® A10005, ANSI/AAMI EC12 compliant silver/silver-chloride (Ag/AgCl) electrodes). Contained within the headset is a wireless EEG amplifier module. The NEBA Headset and its associated software do not provide any diagnostic conclusion or automated alerts of any clinical event about a patient's condition. The NEBA Headset transmits electrophysiological signals from the electrodes to a CEEG 2R IEC/UL 60950-1 safety compliant computer running the NEBA CEEG 2R recording software. The system supports six electrode locations (CZ, left ocular, right ocular, left ear, right ear, and ground) on four flat flexible leads and one plastic tab (the latter to support the CZ electrode). The CEEG2 Headset is intended for use in clinical settings in individuals six years of age and older. (Rx only).

The NEBA® Compact EEG2R Mobile Headset is a battery powered (3.7v Lithium-lon battery wirelessly charged using a Qi-compliant receiver) wireless (Bluetooth LE) EEG headset which facilitates the placement of EEG electrodes. The NEBA® Compact EEG2R Mobile Headset (CEG2R) has both hardware and software components. Hardware comprises an EEG electrode system that serves to conduct EEG potentials from the human scalp for transfer to a built-in wireless EEG amplifier. The software provides EEG amplifier hardware control, recording, storage, and user interfaces for waveform monitoring, patient information entry and storage, and accessing stored EEG data. The CEEG2R Headset has two primary purposes: To aid in EEG electrode positioning on the head such that electrodes are positioned in intended locations accurately and reliably per the standard 10-20 International Electrode Placement System. The default leads configuration includes CZ, left ocular (OC-L), right ocular (OC-R), left ear (E-L), right ear (E-R), and Ground (GND) positions; To transmit electrophysiological signals from positioned electrodes to an EEG recording and monitoring device via an internal EEG amplifier with wireless transfer communication. The CEEG2R Headset is constructed using biocompatible patient contact surfaces, the major components formed of polyurethane and polyester. The headset is held in place using a flexible platform at the top of the head and adjustable arms that terminate at lateral supports at the sides of the head. The headset is designed for use with accessory disposable silver/silver-chloride (Ag/AgCl) electrodes (K781430). An integral, counter posing pressure tab accepts a disposable electrode for placement at the top medial portion of the head (at location CZ of the 10-20 International Electrode Placement System). Connection components facilitate the quick insertion and removal of the electrodes and flexible leads. Electrodes for use on the scalp and hair bearing scalp region use a low-viscosity integrated wet-gel conductive medium embedded in the electrodes along with integrated low-tack adhesive optimized for hair compatibility and system stability. The system is stabilized on the head through use of low tack adhesive-lined electrodes, conformable lateral support linings, spring hinges, and a flexible headband platform. The system interfaces with the CEG2R recording and monitoring software for signal acquisition, signal measurement, and electrode impedance measurement by way of a built-in wireless amplifier. The battery, wireless battery charger, wireless communication transmitter and amplifier printed circuit board (PCB) are located atop a midline-located headband platform of the headset.

The NEBA® Compact EEG2R Mobile Headset is intended to capture, amplify, and wirelessly transmit electrical brain activity for review by a trained medical professional. The device itself does not provide diagnostic conclusions or automated alerts. The FDA letter and K223628 Summary provide information about the device's technical specifications and the testing performed to demonstrate its safety and performance relative to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the primary acceptance criteria revolve around demonstating substantial equivalence to predicate devices, focusing on safety and effectiveness. The document lists performance testing against recognized standards rather than specific acceptance metrics like sensitivity/specificity for a diagnostic claim, as it's not a diagnostic device.

Here's a table summarizing the performance standards the device was tested against and, where available, reported values. Explicit acceptance criteria in terms of performance thresholds (e.g., "noise must be less than X" or "dynamic range must be at least Y") are not detailed as specific numerical targets being met, but rather compliance with the standards' requirements.

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

The provided document does not detail any patient-based test sets or data provenance (country of origin, retrospective/prospective) for clinical performance evaluation. The device is cleared through a 510(k) pathway by demonstrating substantial equivalence to predicate devices primarily through engineering and bench testing, as well as software validation and biocompatibility assessments.

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

Given that "clinical testing was not performed to demonstrate substantial equivalence," there was no ground truth established by experts for a patient test set. The performance evaluations were laboratory-based, adhering to recognized standards.

4. Adjudication Method for the Test Set

As no clinical test set requiring human interpretation or adjudication was conducted for performance claims, there was no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was done. The device emphasizes capturing and transmitting EEG data for review by a trained medical professional; it does not provide diagnostic conclusions or automated alerts, and therefore, its "effectiveness" in improving human reader performance with AI assistance is not applicable to its current stated intended use.

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

The device itself is an EEG headset with an amplifier and software for recording/review. It does not perform automated diagnostic algorithms. Therefore, no standalone algorithm performance study was conducted. The performance assessed relates to the hardware and software functioning correctly to acquire and transmit EEG signals according to engineering standards.

7. The Type of Ground Truth Used

The "ground truth" for the various performance tests was defined by the specifications and requirements of the relevant industry standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, ISO 10993-5) and internal design specifications (e.g., input dynamic range, input noise). For biocompatibility, the chemical composition and biological response of materials according to ISO standards served as the ground truth.

8. The Sample Size for the Training Set

There is no mention of a training set because this device does not utilize machine learning or AI algorithms that would require training data for diagnostic or interpretive functions.

9. How the Ground Truth for the Training Set Was Established

Since no training set was used, there is no information on how its ground truth would have been established.

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