(241 days)
The eego amplifier is intended to be used by or under the direction for acquisition of EEG signals and to transmit them digitally to a computer. The device is intended for use on humans. The device is intended for use in a clinical environment (e.g., hospital, physician's office, etc). The device is not intended for use in life support systems.
The eego amplifier is a multi-channel, plastic enclosed EEG amplifier. There are two ranges for the variations of amplifiers (models):
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- EE-2xx, and
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- EE-4xx.
In total, there are 8 models. The EE-411 and EE-430 amplifiers are built using identical components and share identical internal structure, functionality and performance. The eego amplifier electroencephalography (EEG) input is from commercially available EEG electrodes from the Waveguard™ EEG Cap cleared in K110223. The eego amplifiers support EEG acquisition and storage by:
- EE-4xx.
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- referential DC input channels,
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- parallel trigger input channel.
Electrode Impedance values can be measured for all referential electrodes, reference and patient ground electrode. Signal sampling rate and gain are set through the user interface of the Software Development Kit (SDK). The EE-2XX series of eego amplifier is powered by a built-in, rechargeable battery. The battery provides a minimum of 4 hours of operation time. The amplifier can be applied for data acquisition with the 12 V battery charger source applied. The USB port supports interface to the computer running the SDK. The EE-4XX series of eego amplifier is powered by the USB port connection to a computer.
- parallel trigger input channel.
This document describes the premarket notification for the eego amplifiers, focusing on its substantial equivalence to a predicate device rather than a study proving the device meets specific acceptance criteria for a diagnostic algorithm.
Therefore, many of the requested points regarding diagnostic performance, ground truth, sample sizes for training/test sets, expert adjudication, and comparative effectiveness with AI assistance cannot be extracted Directly from the provided text. The document primarily concerns the safety and performance of a medical device (EEG amplifier) and its compliance with general medical device standards.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific acceptance criteria or quantitative performance metrics for a diagnostic task. Instead, it refers to compliance with international safety and performance standards for medical electrical equipment.
| Acceptance Criteria Category | Reported Device Performance (Compliance) |
|---|---|
| Safety Standards | |
| IEC 60601-1:2005 (DIN EN 60601-1:2007) | Device complies with standards for basic safety and essential performance. |
| IEC 60601-1-2:2007/2014 (EMC) | Device complies with electromagnetic compatibility requirements. |
| IEC 60601-2-26:2012 | Device complies with particular requirements for basic safety and essential performance of electroencephalographs. |
| IEC 62133 Ed. 2.0 2012-12 (Batteries) | Device complies with safety requirements for portable sealed secondary cells and batteries (for EE-2XX series). |
| Functional Equivalence to Predicate | |
| Intended Use | Equivalent to predicate (electrically amplify signals derived from EEG). |
| Indications for Use | Equivalent to predicate (acquisition of EEG signals and digital transmission to computer). |
| Type of Use | Same (Prescription Use). |
| Modes of Operation | Both acquire EEG signals (subject device focuses on EEG, predicate broader). |
| Environment of Use | Same (Clinical environment). |
| Data Storage | Same (Yes). |
| Electrode Impedance Measurement | Same (Yes). |
| Filter | Same (Low pass filtering in amplifier). |
| Patient Contact | Equivalent (No direct patient contact by amplifier, uses external electrodes). |
| Sampling Rate | Equivalent (Subject device: up to 16384 Hz for EE-2XX, up to 2048 Hz for EE-4XX; Predicate: up to 20000 Hz). |
| Video | Option to allow video (subject device) vs. No (predicate) - considered an acceptable difference. |
| Amplifier Active Shielding | Same (Yes). |
| Amplifier CMRR (referential) | >100 dB (subject device) vs. 90 dB (predicate) - subject device performs better, considered equivalent or superior. |
| Amplifier Input Channels | Up to 64 (subject device) vs. Up to 64 (special mode supports 128) (predicate) - considered equivalent. |
| Amplifier Input Impedance (referential) | >10^9 Ohm (subject device) vs. >10^12 Ohm (predicate) - considered equivalent for low impedance physiological signal inputs. |
| Amplifier Power | Subject device: Rechargeable battery (EE-2XX), USB (EE-4XX) vs. Predicate: AC Mains - considered equivalent in function. |
| Amplifier Operating Time on Battery | Up to 4 hours (EE-2XX Series) - N/A for predicate (AC powered). |
| Amplifier Referential DC Input Channels | Yes (8, 16, 32, or 64 channels) vs. Yes (16, 32, 64 or 128 channels) - considered equivalent. |
| Amplifier Trigger Input | Equivalent (Optional TTL, varying bits). |
| Amplifier Trigger Input Channel | Same (Yes, Parallel). |
| Amplifier USB Interface | Same (Yes). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes performance testing for compliance with technical standards, not a diagnostic study involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. Ground truth in the context of diagnostic algorithms is not relevant to this type of device submission, which focuses on hardware performance and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as it is not applicable to the type of device and testing 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, an MRMC comparative effectiveness study was not done. The eego amplifier is a device for signal acquisition, not an AI-powered diagnostic algorithm.
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 device itself is not an algorithm, but hardware for signal acquisition.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the context of diagnostic accuracy. The "ground truth" for the performance testing mentioned would be the established specifications and requirements of the referenced IEC standards.
8. The sample size for the training set
This information is not provided. Training sets are relevant for machine learning algorithms, which is not the primary subject of this submission.
9. How the ground truth for the training set was established
This information is not provided.
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).