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510(k) Data Aggregation
(411 days)
The EEG NeuroAmp II.5s is intended to acquire, display, store and archive the electroencephalographic (EEG) signals from a patient's brain obtained by placing two or more electrodes on the head. It must be used in combination with appropriate software and computer. The EEG NeuroAmp II.5s is also intended to be used to provide stimulation and recording of visual and auditory evoked response potentials with appropriate software, computer, and accessories.
The EEG NeuroAmp II.5s can also be used for biofeedback and relaxation purposes of this training task, information for feedback may be derived from the electroencephalographic signals and from as many as eight channels of peripheral physiology measures such as are conventionally used in biofeedback.
The EEG NeuroAmp II.5s is intended to be used only by trained professionals who can ensure sound handling practices. The device is intended for use in clinical environments (not surgical or emergency environments) as well as in medical and therapeutic practices. It can be used with patients of all ages but is not designed for fetal use.
The device does not draw any diagnostic conclusion. Recorded data of electroencephalogram (EEG) signals or event related potentials (ERPs) need to be interpreted by a clinical expert. The results of such interpretation must be considered only in conjunction with other clinical findings.
The EEG NeuroAmp II.5s is a user-friendly high-performance interface between client and clinician computer. It can be used in two different functionalities: In an EEG/ERP measurement and in an EEG biofeedback (neurofeedback) and/or peripheral biofeedback setting. The EEG NeuroAmp 11.5s device itself contains three function blocks:
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- EEG amplifier, two channels, interface for 23- or 39-channel EEG recording front-end
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- Impedance meter function
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- peripheral channels for additional sensors, ERP synchronization and biofeedback
Apart from the EEG-biofeedback functionality, together with the x23/x39 accessories, it is possible to utilize the equipment as an EEG/ERP measurement device. A 23- or 39-channel EEG can be measured with conventional EEG caps, which are not part of the device, according to the standard 10-20 system. The device does not draw any diagnostic conclusions and does not invite the clinician to do so. Recorded data of electroencephalogram (EEG) signals need to be interpreted by a clinical expert. The results of such interpretation must be considered in conjunction with other clinical findings to provide context. There is no therapeutic effect of the EEG NeuroAmp II.5s used in this setting.
The NeuroAmp x23/x39 devices are a full 23-/39-channel digital EEG recording front-end with integrated impedance meter. They are an accessory to the EEG NeuroAmp 11.5s and work only in conjunction with it.
The Corscience EEG NeuroAmp II.5s is an electroencephalograph device that functions for EEG/ERP measurement and biofeedback. The device received 510(k) clearance based on substantial equivalence to predicate devices, demonstrating its safety and effectiveness through performance testing against relevant IEC and ISO standards.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the EEG NeuroAmp II.5s are implicitly defined by its performance against the specified technical requirements, which are shown to be equivalent or superior to predicate devices. The "Discussion on safety and effectiveness" column in the comparative table effectively serves as the acceptance criteria and performance review.
| Specification | Acceptance Criteria (from predicate comparison) | Reported Device Performance (EEG NeuroAmp II.5s) |
|---|---|---|
| EEG/ERP Measurement Functionality | ||
| Indications for Use (short version) | Acquire, display, store, and archive electrical activity of a patient's brain (Mitsar EEG and Natus Brain Monitor also allow stimulation and recording of evoked response potentials). | Acquire, display, store and archive the electroencephalographic (EEG) signals from a patient's brain obtained by placing two or more electrodes on the head incl. stimulation and recording of visual and auditory evoked response potentials. |
| Common name, Product code, Regulation number | GWQ, 21 CFR 882.1400 (Mitsar EEG); GWQ & OLV, 21 CFR 882.1400 (Natus Brain Monitor) | EEG/ERP measurement & biofeedback device, GWQ, GWE, GWJ, OLV & HCC, 21 CFR 882.1400, 21 CFR 882.5050, 21 CFR 882.1890 & 21 CFR 882.1900 |
| Power supply | Primarily USB port for power, with galvanic isolation (for EEG NeuroAmp, presumed for Mitsar EEG). | Power supply via USB port (galvanic isolation according to IEC 60601-1) |
| Software | EEG Studio (Mitsar EEG); Natus NeuroWorks™/SleepWorks (Natus Brain Monitor) | ERPrec |
| Windows 10 and 7 compatible | Windows 7, perhaps also Windows 10 (Mitsar EEG); Yes (Natus Brain Monitor) | Yes |
| EEG channels | 21 + 4 active/reference pairs, one auxiliary channel (Mitsar EEG); 40 (Natus Brain Monitor) | up to 41 plus 8 peripheral channels |
| Resolution EEG channels | 16 bit (Mitsar EEG); 24 bit (16 bit stored) (Natus Brain Monitor) | 24 bit, stored loss-free 24bit and full sampling rate |
| Sampling frequency | 500 Hz per channel, multiplexed (Mitsar EEG); 256, 512, 1024, 2048, 4096 (Natus Brain Monitor) | 1Msample/second gross sampling rate, down sampled to 250 or 500 sps. synchronous sampling over all EEG- and peripheral channels |
| Common-Mode Rejection Ratio (CMRR) | at least 100 dB at 10 Hz (Mitsar EEG); >106db@60Hz (Natus Brain Monitor) | >130 dB |
| Notch filter | -30 dB at 50(60) Hz (Mitsar EEG); No data (Natus Brain Monitor) | <-60 dB at 50 or 60 Hz,optional setting in software. Recording always unfiltered raw signal. |
| Input impedance EEG channels | > 200 MΩ (Mitsar EEG); >1000 MOhm (Natus Brain Monitor) | >1000 MOhm |
| Bandwidth (3dB) and sample rate | 0.16 – 70 Hz (Mitsar EEG); 0.1 Hz – 100 Hz (Natus Brain Monitor) | DC ... 100Hz/160Hz |
| Impedance measurement EEG electrodes (electrode contact quality) | Yes, 5kΩ – 40kΩ (Mitsar EEG); Yes, 2.5kΩ, 5kΩ, 10kΩ, 25kΩ (Natus Brain Monitor) | Yes, 0 ... 140kΩ |
| Input Noise | < 1.5 µV peak to peak (Mitsar EEG); ≤ 2 uV pk-to-pk (0.1Hz to 100 Hz) (Natus Brain Monitor) | < 0.01µV/√Hz; < 1.0 µV peak toPeak |
| Overvoltage warning | No data (Mitsar EEG and Natus Brain Monitor) | yes |
| Input signal range | 10 - 5000 µV (Mitsar EEG); 20mV pk-to-pk, +/- 0.3VDC (Natus Brain Monitor) | 1100mVp-p |
| Maximum Operational DC input voltage electrode offset | ±350 mV (Offset tolerance) (Mitsar EEG); ±300mV (Natus Brain Monitor) | ±550mV |
| ERP measurement: synchronization mechanism and precision in ms | Event button, No active synchronization, Accuracy/jitter: ±10ms/<20ms (Mitsar EEG); Integrated 8-bit trigger, Accuracy/jitter: ±10ms/<20ms (Natus Brain Monitor) | Active audio and video synchronization with Sync device; Event button, 24 bit trigger.. Accuracy/jitter: ±1ms/<1ms |
| Visual and auditory stimuli for ERP measurement | Stimulus presentation software incorporated, Audio and video sensors for initial calibration (Mitsar EEG); No data (Natus Brain Monitor) | Stimulus presentation software incorporated in software ERPrec Audio and video sensors for continuous calibration and selftest of the system initial to each recording. |
| Measurement of physiological data | Multi-purpose inputs for peripheral biosignal acquisition (Mitsar EEG); SpO2 Pulse Rate, Plethysmogram, PPG (Natus Brain Monitor) | Combination sensor, applied to the finger, for heart rate and galvanic skin response (GSR). Skin temperature of the finger can be measured, not absolute values, only trends. No therapeutic effect of sensor. |
| Video recording | Possible (Mitsar EEG and Natus Brain Monitor) | Possible |
| EEG-Biofeedback (Neurofeedback) Functionality | ||
| Indications for Use | Biofeedback and relaxation purposes (EEG NeuroAmp) | Biofeedback and relaxation purposes |
| Common name, Product code, Regulation number | Biofeedback device, HCC, 21 CFR 882.5050 (EEG NeuroAmp) | EEG/ERP measurement & biofeedback device, GWQ, GWE, GWJ, OLV & HCC, 21 CFR 882.1400, 21 CFR 882.5050, 21 CFR 882.1890 & 21 CFR 882.1900 |
| Power supply | Power supply via USB port (galvanic isolation according to IEC 60601-1) (EEG NeuroAmp) | Power supply via USB port (galvanic isolation according to IEC 60601-1) |
| Software | Cygnet, BEE Lab (EEG NeuroAmp) | Cygnet, BEE Lab |
| Windows 10 and 7 compatible | Yes (EEG NeuroAmp) | Yes |
| x23/x39 EEG amplifier interface | No (EEG NeuroAmp) | Yes |
| No. peripheral channels inputs | 3 (EEG NeuroAmp) | 8 |
| No. peripheral channels outputs | 1 (EEG NeuroAmp) | 8 |
| EEG resolution | 13 bit (EEG NeuroAmp) | 32 bit |
| Input noise | < 1.5 µVp-p (EEG NeuroAmp) | < 0.01 µV/ √Hz ; < 1.0 µVp-p |
| Overvoltage warning | Yes (EEG NeuroAmp) | yes |
| EEG bandwidth | 0.056 ... 70Hz (EEG NeuroAmp) | DC ... 100/160Hz |
| Peripheral channel resolution | 13 bit (EEG NeuroAmp) | 24 bit |
| Peripheral channel bandwidth | DC ... 70Hz (EEG NeuroAmp) | DC ... 100/160Hz |
2. Sample size used for the test set and data provenance
The document does not describe a clinical study with a "test set" of patient data for the device to be evaluated. The performance testing conducted was:
- Electrical Safety: Bench testing according to IEC 60601-1.
- Electromagnetic Compatibility: Bench testing according to IEC 60601-1-2 and IEC 60601-2-26.
- Performance Testing (Hardware): Bench testing in accordance with internal requirements and applicable clauses of IEC 62366-1, IEC 80601-2-26, and IEC 60601-2-40.
The accessorizes were also tested to ISO 10993-1, IEC 60601-1 and IEC 60601-1-2.
Therefore, there is no mention of sample size or data provenance in terms of patient data.
3. Number of experts used to establish the ground truth for the test set and their qualifications
This information is not applicable as there was no test set of patient data requiring expert ground truth establishment. The device capabilities were verified through technical bench testing against established engineering standards and specifications.
4. Adjudication method for the test set
This information is not applicable as there was no test set of patient data requiring adjudication.
5. Multi-reader multi-case (MRMC) comparative effectiveness study
No MRMC study was performed or described. The study focused on technical equivalence and performance against predicate devices and standards, not on human reader performance with or without AI assistance. The device does not draw any diagnostic conclusion and requires interpretation by a clinical expert.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) study
No standalone performance study of an algorithm was conducted or described. The device is a hardware system for acquiring, displaying, storing, and archiving EEG signals, with capabilities for biofeedback and evoked response potentials. It's explicitly stated that the device "does not draw any diagnostic conclusion" and "Recorded data... need to be interpreted by a clinical expert."
7. Type of ground truth used
The "ground truth" for evaluating the EEG NeuroAmp II.5s was based on:
- Adherence to international electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, ISO 10993-1 for accessories).
- Compliance with device-specific performance standards for electroencephalographs and evoked response equipment (IEC 80601-2-26, IEC 60601-2-40).
- Comparison of technical specifications against legally marketed predicate devices (Mitsar EEG K143233, Natus Brain Monitor K180290, EEG NeuroAmp K073557) to demonstrate substantial equivalence and often superior performance.
8. Sample size for the training set
This information is not applicable as the device is a medical measurement instrument and not an AI/ML algorithm that requires a training set of data.
9. How the ground truth for the training set was established
This information is not applicable as there was no training set of data.
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