(128 days)
The Vigilant EEG Monitor (Vigilant 2.0) is an electroencephalograph that works in conjunction with Vigilant bedside monitoring and remote review software. It is intended for measuring and recording the electrical activity of a patient's brain by applying 8 electrodes on the head.
The Vigilant EEG Monitor (Vigilant 2.0) requires competent user input, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information.
The Vigilant EEG Monitor (Model Vigilant 2.0) is a multi-channel EEG monitor. It is intended for monitoring the state of the brain by applying electrodes to a patient's head. It also includes software to enable remote monitoring by a neurologist or other trained personnel. Both acquisition and review of patient data can be performed at the bedside.
The Vigilant EEG Monitor does not include a computer monitor or video camera, but these are required for system use.
The Vigilant EEG Monitor consists of an EEG acquisition console with junction box and a software CD (bedside EEG monitoring software, server software for remote telecommunications and software for remote monitoring of EEG data). The principal component of the Vigilant EEG monitor is a Porti amplifier and power supply provided by TMS International (Oldenzaal, The Netherlands). The software is designed to be loaded onto an off the shelf computer monitor that may be supplied by the user. It is also designed to interface with a video camera for real-time video monitoring concurrently with EEG monitoring. Neither the computer nor the camera is considered part of the medical device.
The EEG signal display can be configured in a reduced mode (up to 4 EEG channels plus quantitative EEG metrics for each channel) or a full mode (up to 8 EEG channels). The display modes and channel display are configurable by the user.
In the reduced mode display, the user may select to display either the spectral edge frequency (SEF 95) as a line graph, or the power spectrum (POWER) displayed as four colored line graphs, each representing the standard EEG frequency bands (delta: 0-4Hz, RED: theta: 4-8Hz, YELLOW; alpha: 8-13Hz, GREEN; beta: 13-30Hz, BLUE).
Real-time video of the patient from the system camera is displayed in a separate window from the EEG signals. This window may be hidden or resized by the user. The video is recorded in synchronization with the EEG even when it is not displayed and may be replayed during review mode.
The provided 510(k) summary for the Vigilant 2.0 EEG Monitor indicates that the device's performance was evaluated through laboratory testing, demonstrating it met its design and functional requirements. However, it does not include a detailed study with specific acceptance criteria and reported device performance as requested. The document primarily focuses on establishing substantial equivalence to predicate devices based on intended use, technological characteristics, and principles of operation, rather than providing a performance study with quantitative metrics.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's a breakdown of what can and cannot be answered based on the input:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific quantitative acceptance criteria are not provided in the document. | "Actual device functions and features were evaluated against the device specifications and in all instances the Vigilant Monitor performed as expected and no unexpected behavior was observed. The device meets the requirements for safety of medical electrical equipment, electromagnetic compatibility, and the particular standard for electroencephalographs." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified, but the testing was described as "Laboratory testing," suggesting it was conducted internally by the manufacturer or a contracted lab. The country of origin of the data is not mentioned.
- Retrospective/Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as no "ground truth" was established in the context of a clinical performance study. The evaluation focused on meeting design and functional specifications. The device's output "must be reviewed and interpreted by trained medical professionals who will exercise professional judgment."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no adjudication method for a test set is described.
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 or mentioned. The device is an electroencephalograph, intended for measuring and recording, with output reviewed by trained medical professionals. It is not an AI-assisted diagnostic tool in the sense of providing automated interpretations that would be compared to human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document describes "Laboratory testing" where the device's functions and features were evaluated against specifications. This can be interpreted as a form of standalone performance evaluation for the hardware and software components, but it's not a clinical standalone performance study comparing its diagnostic accuracy to a ground truth. The device is explicitly stated to "require competent user input" and its output "must be reviewed and interpreted by trained medical professionals."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of a clinical performance study measuring accuracy against a "ground truth." The evaluation focused on the device's ability to "meet its design and functional requirements" and specifications for safety and electromagnetic compatibility.
8. The sample size for the training set
- Not applicable. This device is an EEG monitor, not a machine learning or AI-driven diagnostic algorithm that would typically have a "training set."
9. How the ground truth for the training set was established
- Not applicable (see point 8).
§ 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).