(443 days)
The NeuroFAST Monitoring System, Model NF-201 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 NeuroFAST NF-201 is indicated for use in acquiring electroencephalographic (EEG) signals in the OR, ICU, ER, clinical settings and for clinical research. The NeuroFAST Monitor is to be used under the direction and interpretation of a licensed medical professional. The NeuroFAST Monitoring System, Model NF-201 does not provide any diagnostic conclusion about the patient's condition.
The NeuroFAST Monitoring System, Model NF-201, is an EEG monitor that records and displays electroencephalograms (EEGs) obtained from noninvasive electrodes placed on a patient's head. The acquired EEG waveforms and processed EEG variables are continuously displayed by the system for interpretation by the licensed medical professional. The NeuroFAST Monitoring System, Model NF-201 has three main components: Display Module (DM-201), Patient Module (PM-201), and EasyPrep Sensor Kit (EK-701).
The NeuroFAST Monitoring System, Model NF-201, is an EEG monitor. The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness through specific clinical performance criteria. Therefore, the information regarding acceptance criteria and a study proving device performance as typically understood for new medical devices with specific performance claims (e.g., diagnostic accuracy) is not present in the same way it would be for analytical or clinical performance studies.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this 510(k) is for an EEG monitor, the "acceptance criteria" are primarily related to its technical specifications and compliance with relevant standards, demonstrating that it functions equivalently to existing devices. There aren't specific diagnostic performance metrics (e.g., sensitivity, specificity) listed as acceptance criteria that a study would then "prove" the device meets.
Instead, the acceptance criteria are implicitly met by showing the device's technical specifications and intended use are similar to predicate devices and that it complies with relevant safety and technical standards.
| Feature / Standard | Acceptance Criteria (Implied) | Reported Device Performance (NeuroFAST NF-201) |
|---|---|---|
| Intended Use | Consistent with 21 CFR 882.1400 (Electroencephalograph) | Measuring and recording electrical activity of the brain, acquiring EEG signals in OR, ICU, ER, clinical settings, and for clinical research. No diagnostic conclusion provided. |
| Modalities | EEG | EEG |
| Environment of Use | Hospitals and Clinics | Operating room, intensive care unit, emergency room, and clinical settings where EEG monitoring is used. |
| Sensing Electrodes | Standard EEG electrodes | Silver-silver chloride disposable EEG electrodes (EasyPrep Sensor Kit) |
| Screen Display | Raw EEG waveforms and spectral parameters | Displays: Raw EEG Waveforms, Spectral Parameters (EEG power spectrum and frequency bands, 50% Median Edge Frequency (MEF), and 95% Spectral Edge Frequency (SEF)) |
| Stored EEG data | Yes | Yes - through removable storage |
| EEG Channels | Multiple channels, typically 2 or more for EEG monitoring | 2 bilateral frontal channels viewed concurrently |
| Real Time Display | Yes | Yes |
| Processed Bandwidth | Appropriate for EEG | User Selectable: Low Filter: 0.125 or 0.5 Hz, High Filter: 30 or 70 Hz |
| Automatic Artifacting | Yes | Yes |
| Amplifier CMRR | ≥ 100 dB | ≥100 dB |
| Amplifier Input Impedance | ≥ 50 Meg Ohms (Predicate: ≥ 100 Meg Ohms) | ≥50 Meg Ohm |
| Electrode Impedance Test | Yes | Yes - Continuous and on demand |
| Derived/Processed EEG Measures | Power spectrum parameters common to EEG monitors | Power spectrum parameters derived from FFT: Power spectrum (Density Spectral Array), 95% Spectral Edge Frequency (SEF), Median Edge Frequency (MEF), Spectral Powers in EEG frequency bands (α, β1, β2, δ, θ and γ) |
| Patient Isolation | Electrical isolation for patient safety | Yes - Patient module (analog-to-digital converter) provides 6kV electrical isolation of the patient from the monitor. |
| Safety Standards | Compliance with Medical Electrical Equipment and Electroencephalograph Standards (IEC/UL) | Complies with IEC60601-1, IEC60601-1-4, IEC60601-2-26. Will meet UL medical electrical equipment standards for safety. |
| EMC Standards | Compliance with Electromagnetic Compatibility Standards (IEC) | Complies with IEC60601-1-2, IEC60601-2-26. |
| Functional Requirements | Meets design and functional requirements; performs as expected. | Laboratory testing on identical hardware demonstrated that the NeuroFAST Monitoring System, Model NF-201 meets its design and functional requirements, including IFCN Guidelines for electroencephalographs. Actual device functions and features were evaluated against the device specifications and in all instances the NeuroFAST NF-201 performed as expected and no unexpected behavior was observed. |
Study Proving Device Meets Acceptance Criteria:
The key study mentioned is non-clinical bench testing.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable in the traditional sense for a clinical performance study. The "test set" in this context refers to the device itself and its components undergoing engineering and functional verification. The summary states "Laboratory testing, performed on identical hardware to the NeuroFAST subject of this submission..." This implies testing was done on units of the device, not a sample of patient data.
- Data Provenance: Not applicable. The testing described is hardware and functional verification, not data from patients. There is no mention of country of origin or retrospective/prospective nature as clinical data was not used.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. For hardware and functional testing, "ground truth" is typically established by engineering specifications, international standards, and comparison with predicate device functionalities, not through expert reading of data generated by the device.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. The testing described is objective measurement against specifications and visual verification of expected device behavior, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. The summary explicitly states: "We believe further clinical data is not required to demonstrate performance for the NeuroFAST NF-201 for the indication for use subject to this submission." This indicates that the regulatory pathway relied on demonstrating substantial equivalence through technical specifications and non-clinical testing rather than proving improved human reader performance with or without AI assistance.
- Effect Size: Not applicable as no such study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, a standalone algorithm performance study was not done. The NeuroFAST Monitoring System, Model NF-201 is described as an EEG monitor that records and displays EEGs for interpretation by a licensed medical professional. It "does not provide any diagnostic conclusion about the patient's condition." This means it's a data acquisition and display device, not an AI-powered diagnostic algorithm. Its performance is intrinsically tied to its ability to accurately acquire and present physiological signals, not to generate a standalone interpretation.
7. Type of Ground Truth Used:
- Ground Truth: For the non-clinical testing, the "ground truth" was the device's own design and functional requirements, IFCN Guidelines for electroencephalographs, device specifications, and relevant international safety and EMC standards (IEC60601-1, IEC60601-1-4, IEC60601-2-26, IEC60601-1-2). The performance was evaluated against these predetermined engineering and regulatory benchmarks.
8. Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This device is an EEG monitor, not an AI/ML algorithm that requires a training set in the conventional sense. Its function is to acquire and display biological signals, not to learn patterns from data.
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.
§ 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).