(222 days)
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
| Performance Characteristic | Acceptance Criteria | Reported Device Performance & Results |
|---|---|---|
| Burst Suppression Ratio |
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).