(71 days)
The EEG NeuroAmp is intended for biofeedback and relaxation purposes. To perform its intended function it must be used in combination with a computer and appropriate software.
For purposes of this training task, information for feedback may be derived from one or two channels of EEG and from as many as three channels of peripheral physiology measures such as are conventionally used in biofeedback.
The EEG NeuroAmp is intended to be used in the office by trained professionals who can ensure sound handling practices.
The EEG NeuroAmp is not intended for diagnostic purposes.
The purpose of the EEG NeuroAmp is to act as user-friendly high-performance interface between client and clinician computer for EEG biofeedback) and/or peripheral biofeedback therapy. The EEG NeuroAmp contains four function blocks:
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- EEG amplifier, two channels, aligned and high-resolution
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- Built-in impedance meter for five electrodes helps achieve good electrode contact and warns if electrodes are worn out
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- Peripheral sensor amplifiers, three channels, allow measurement of peripheral biofeedback signals such as GSR (Galvanic Skin Response) and temperature. The latter may be by means of a contact probe (thermistor) or non-contact infrared thermal sensor (infrared thermometer).
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- An output for audio/visual/tactile feedback
The Corscience GmbH & Co. KG EEG NeuroAmp is a biofeedback device intended for biofeedback and relaxation purposes.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to predicate devices and compliance with relevant standards. It does not explicitly define "acceptance criteria" in terms of specific performance metrics for the overall device's therapeutic effectiveness (e.g., a percentage reduction in a particular symptom). Instead, the acceptance is based on meeting safety and technical standards and demonstrating comparable performance to predicate devices for its intended use.
However, some technical specifications can be viewed as performance characteristics that were likely expected to meet certain thresholds or be comparable to predicate devices.
| Parameter | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (EEG NeuroAmp) |
|---|---|---|
| Intended Use | Biofeedback and relaxation purposes. Must be used with computer and software. Data from 1-2 EEG channels and up to 3 peripheral physiology measures. For use by trained professionals in an office setting. Not for diagnostic purposes. | The EEG NeuroAmp is intended for biofeedback and relaxation purposes. To perform its intended function it must be used in combination with a computer and appropriate software (Cygnet). For purposes of this training task, information for feedback may be derived from one or two channels of EEG and from as many as three channels of peripheral physiology measures such as are conventionally used in biofeedback. The EEG NeuroAmp is intended to be used in the office by trained professionals who can ensure sound handling practices. The EEG NeuroAmp is not intended for diagnostic purposes. |
| Power Supply | Acceptable and safe power source. | Power supply via USB port (galvanic isolation according to IEC 60601-1). |
| Software | Functional and appropriate for biofeedback. | Cygnet |
| No. of Input Channels | Comparable to predicate devices (BrainMaster had 2, ProComp had 8). | 5 |
| No. of Output Channels | Comparable to predicate devices (Predicates had 0). | 1 |
| ADC Resolution | Comparable to predicate devices (BrainMaster 8 bit, ProComp 14 bit). | 13 bit |
| Anti-aliasing Filter | Present for effective signal processing. | 5th order Butterworth |
| DC Gain Accuracy | Comparable to predicate devices (BrainMaster ±5%, ProComp ±0.5%). | ±1% |
| DC Offset | Comparable to predicate devices (BrainMaster +4 LSB, ProComp +3 LSB). | +1 LSB |
| Bandwidth (3dB) & Sample Rate | Appropriate for EEG and peripheral biofeedback. | EEG amplifier (2 channels): 0.08 Hz (1st order roll-off) ...70 (5th order roll-off). Sample rate for 50Hz line: 1000 sps. Sample rate for 60Hz line: 960 sps. Subsample rate = sample rate / 4 (250/240). Peripheral Amplifier (3 channels): DC ... 10Hz. Same sampling rate scheme. |
| Full-scale Input Range, DC | Appropriate for biofeedback signals. | ± 250 mV |
| Overvoltage Warning | Desirable for safety (ProComp/BrainMaster lacked this). | Yes |
| Impedance Measurement | Ability to check electrode contact quality. | Both channels simultaneously; displayed by colored LED bars on device. Needs to be engaged explicitly, disabled during EEG neurofeedback. |
| CMRR - EEG sensor only | High common-mode rejection for signal quality (>100 dB for BrainMaster, >130 dB for ProComp). | >130 dB |
| Temperature Range (pIRx3 accessory) | Suitable for forehead temperature measurement. | 29°C - 43°C or 84°F - 109°F |
| Accuracy (pIRx3 accessory) | Accurate enough for biofeedback (ProComp ±1.0°C). | 130 dB would be the "ground truth" to which the device's measured performance was compared during testing. |
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is a hardware biofeedback system, not an AI/ML algorithm that requires a training set of data.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. As there is no AI/ML algorithm involved, there is no training set or ground truth for such a set.
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.