(175 days)
The I-2000 Monitor is intended to be used for measuring and recording the electrical activity of a patient's brain, obtained by placing electrodes on the head.
The I-2000 Monitor is indicated for use in monitoring the state of the brain by acquisition of electroencephalogram (EEG) signals, in research and clinical environments.
The I-2000 Monitor is a two-channel EEG monitor and consists of a tablet PC, battery powered wireless headbox, headbox charger, and power conditioner integrated into a mobile console. The tablet PC provides processing, display, and storage of EEG signals.
User operation of the Monitor is accomplished using the graphical user interface and touch screen tablet PC. The signal display formats are EEG waveforms, EEG power spectrum, and 95% Spectral Edge Frequency. Various amplitude display scales are available and event marking capability is provided. The screen is adjustable for user comfort.
The power spectrum will be displayed as a line graph for each of the four frequency bands traditionally used to quantify EEG signals [Delta (0-4 Hz), Theta (4-8Hz), Alpha (8-13Hz) and Beta (13-30 Hz)] over time. The 95% spectral edge frequency is the frequency below which 95% of the total EEG power is concentrated. This is also displayed as a line graph over time.
The headbox provides amplification, digitization, and transmission of EEG signals. Wireless Bluetooth communication provides complete electrical isolation of the patient from the monitor. The headbox is recharged in a custom charger within the console when not being used for monitoring.
EEG signal processing includes data checking for artifact and electrode contact impedance. Stored EEG signals may be exported to removable storage.
The integrated console features a stable base with 6 casters and a power conditioner to provide an additional protection barrier for both users and patients.
Please find the requested information regarding the acceptance criteria and study details for the Infinite Biomedical Technologies' I-2000 Monitor below.
Acceptance Criteria and Reported Device Performance
This 510(k) summary does not explicitly list quantitative acceptance criteria with specific threshold values for the I-2000 Monitor's performance. Instead, it uses a qualitative statement that the device meets its design and functional requirements.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device meets design and functional requirements. | "In all instances the I-2000 Monitor performed as expected and no unexpected behavior was observed. The device meets the requirements of UL medical electrical equipment standards for safety and the IEC particular standard for electroencephalographs." |
Study Details
Based on the provided text, the submission relies on internal laboratory testing and compliance with relevant safety standards rather than a comparative clinical study with a defined test set, ground truth experts, or complex adjudication methods.
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not specify a sample size for a "test set" in the context of clinical performance. The "testing" appears to refer to internal laboratory validation against design specifications and compliance with standards.
- Data provenance is not mentioned. The testing described is internal "Laboratory testing."
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The document describes technical performance validation rather than medical ground truth establishment using experts.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable/not provided. The testing was focused on device functionality and safety standards, not on interpreting EEG signals using human readers and adjudication.
-
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 study was done. This device is an EEG monitor, not an AI-assisted interpretation tool. The submission focuses on the monitor's ability to acquire and display EEG signals.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the typical sense of an "algorithm-only" performance for AI. The device itself is the "algorithm only" in that it acquires, processes, and displays EEG signals. The performance data section confirms that "actual device functions and features were evaluated against the device specifications."
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Device specifications and recognized standards (UL medical electrical equipment standards and IEC particular standard for electroencephalographs) appear to serve as the "ground truth" for the device's technical and safety performance. There is no mention of medical ground truth (e.g., diagnosis based on expert consensus or pathology) as would be relevant for a diagnostic interpretation device.
-
The sample size for the training set:
- Not applicable/Not provided. This is not an AI/machine learning device that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable/Not provided. As there is no training set mentioned, there is no ground truth established for it.
§ 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).