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The Pascall Systems, Inc. Wireless EEG System, is intended to be used for measuring the electrical activity of a patient's brain, obtained by placing electrodes on the forehead and wirelessly transmitting the electroencephalographic (EEG) signals for storage and display. The Pascall Systems, Inc. Wireless EEG System, is intended for use in the acquisition of EEG signals, displaying them in real time and storing them for later review and analysis. The Pascall Systems, Inc. Wireless EEG System, is intended for use in a hospital Operating Room, Post Anesthesia Care Unit, Intensive Care Unit, Emergency Department, or in other medical facilities such as inpatient and outpatient (ambulatory) surgery settings.

The Pascall Systems, Inc. Wireless EEG System is indicated for use on patients 18 years of age or older and is to be used by licensed medical professionals that have been adequately trained in the use and interpretation of raw EEG data for determination of brain state during anesthesia. The Pascall Systems, Inc. Wireless EEG System does not provide any diagnostic conclusion about the patient's condition.

The Pascall Systems Wireless EEG system is a brain monitoring or Electroencephalographic (EEG) device. The system is designed to record and display four channels of electroencephalograms (EEGs) obtained from noninvasive electrodes placed on a patient's head. The acquired EEG waveforms (4 channels) and processed EEG variables which include a Spectrogram, Artifact index, electromyography (EMG) index, burstsuppression probability, and phase-amplitude modulogram are continuously displayed by the system. Licensed medical professionals which include anesthesiologists, nurse anesthetists, etc. combine and interpret the data presented by the Pascall Systems Wireless EEG with information provided by other instruments in the operating room. The primary purpose of the Pascall Systems Wireless EEG is in the acquisition of electroencephalographic (EEG) signals, displaying them along with the processed variables in real time and storing them for later review and analysis. The Wireless EEG system is intended for use in a hospital Operating Room, Post Anesthesia Care Unit, Intensive Unit, Emergency Department, or in other medical facilities such as inpatient and outpatient (ambulatory) surgery settings.

The provided text describes the Pascall Systems, Inc. Wireless EEG System and its substantial equivalence to predicate devices, but it does not contain a specific study demonstrating direct acceptance criteria for an AI/algorithm's performance. Instead, it focuses on the device's overall performance as an EEG system against established medical device standards and a comparison to predicate devices, particularly regarding its functional components and display features.

However, the document does mention testing related to the "Burst Suppression Ratio" (BSR) which involves a comparison to "manual review of the raw EEG timeseries." This can be interpreted as a form of algorithm performance evaluation.

Here's an attempt to extract and synthesize the information based on your request, focusing on the BSR "study" as the most relevant part, and acknowledging the limitations in the provided text:

Study and Acceptance Criteria Description (Focused on Burst Suppression Ratio - BSR)

The Pascall Systems, Inc. Wireless EEG System underwent non-clinical bench performance testing, which included a specific test to establish substantial equivalence of its Burst Suppression Ratio (BSR) output.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: 49 segments of EEG signals from 10 patients.
• Data Provenance: Not explicitly stated (e.g., country of origin). The data is implicitly retrospective as it involved "segments of EEG signals from 10 patients."

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified, but the ground truth was "manual review of the raw EEG timeseries," implying review by qualified professionals (likely neurologists or neurophysiologists experienced in EEG interpretation, though not explicitly stated).

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. However, since the ground truth was "manual review," it implies direct human interpretation rather than a multi-reader consensus method like 2+1 or 3+1. It's possible a single expert or an unspecified number of experts performed the "manual review."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was it done?: No. The document does not describe an MRMC study comparing human readers with and without AI assistance. The testing focuses on the device's internal performance against a manual ground truth.

6. Standalone (Algorithm-Only) Performance Study

• Was it done?: Yes, for the Burst Suppression Ratio (BSR) calculation. The device's algorithm for BSR was tested by "repeatedly inputting 49 segments of EEG signals" and comparing its output to "manual review." This represents a standalone performance evaluation of the BSR computation. The validation of the real-time Spectrogram, Phase-Amplitude display, and EMG Index using "known simulated input signals" also constitutes a standalone performance evaluation of these specific algorithms/outputs.

7. Type of Ground Truth Used

• Ground Truth Type: Expert consensus/manual review (specifically, "manual review of the raw EEG timeseries" for BSR). For other outputs like Spectrogram, Phase-Amplitude, and EMG Index, "known simulated input signals" were used, which acts as a defined ground truth.

8. Sample Size for the Training Set

• Training Set Sample Size: Not specified. The document does not provide details about a training set, implying that either the device's algorithms are not machine learning-based in a way that requires explicit training data disclosure in this context, or that information was not deemed necessary for this 510(k) summary.

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

• Ground Truth Establishment for Training Set: Not applicable as a training set is not described.

Summary of Device Performance (General)

Beyond the specific BSR study, the document broadly describes the Pascall Systems, Inc. Wireless EEG System's performance in comparison to predicate devices and relevant standards:

• Non-Clinical Bench Performance Testing: The system was tested in accordance with performance standards for electroencephalographic devices (IEC 60601-1, IEC 60601-1-2, IEC 80601-2-26, ISO 10993 Parts 5 and 10).
• Test Objectives: To verify claimed ranges of measurement, essential performance requirements (amplitude/rate accuracy, dynamic range, noise, frequency response, common mode rejection).
• Test Methods: Bench testing on end-to-end systems with simulated input.
• Pass/Fail Criteria: Compliance with claimed range and precision in labeling.
• Results Summary: The system met all applicable specifications and was found substantially equivalent to the predicate device.
• Biocompatibility: Patient-contacting materials passed ISO 10993 tests for cytotoxicity, skin sensitization, and skin irritation.

Overall Conclusion from the document: The Pascall Systems, Inc. Wireless EEG System is substantially equivalent to the predicate device based on review of test results and comparison of characteristics and specifications.

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