(133 days)
The R-40 EEG Amplifier is intended to be used as a front-end amplifier to acquire, store and transmit electrophysiological signals (wireless or cabled).
The R-40 EEG Amplifier is a multi-channel electroencephalograph designed for use in routine EEG and lab monitoring applications.
It is a compact USB 40-channel amplifier which incorporates 32 referential channels and 8 polygraphic channels with built-in calibration and electrode impedance measurement. A Nonin pulse oximeter interface is provided, a Patient Event input, 2 Aux DC inputs and an Electrocap connector. Optional wireless communication is available (Bluetooth and WLAN WiFi).
The Amplifier is intended to be connected to a USB port on a PC which is powered from a medically approved power supply.
This equipment is intended only as an adjunct device in patient assessment; it must be used in conjunction with other methods of patient diagnosis. The equipment does not sustain or support life.
The provided text is a 510(k) summary for the Lifelines R-40 EEG Amplifier. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics in the way a clinical trial or algorithm performance study would.
Therefore, the information required to populate the table and answer the study-related questions comprehensively is not available in the provided text.
Here's why and what can be inferred:
1. A table of acceptance criteria and the reported device performance
- Not Available. The document states "The Lifeline R-40 EEG Amplifier meets the functional claims and intended use as described in the product labeling." and "The safety and effectiveness are substantially equivalent to the predicate device, Nicolet Wireless EEG Amplifier." However, it does not explicitly list quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio within a certain range) and corresponding device performance values against those criteria. The approval is based on demonstrating equivalence rather than meeting specific pre-defined performance thresholds for a novel diagnostic claim.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Available. The document explicitly states: "Clinical testing was not performed with this device." This implies there was no "test set" in the context of a clinical performance study. The evaluation was based on engineering and safety testing, and comparison of technical characteristics to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable/Not Available. As no clinical testing was performed, there was no test set requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Available. No test set or clinical data requiring adjudication.
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. This device is an EEG amplifier, not an AI-powered diagnostic algorithm designed to assist human readers. Therefore, an MRMC study related to AI assistance is not relevant or applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is hardware (an EEG amplifier), not an algorithm that would be evaluated for standalone performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. No clinical ground truth was established as no clinical testing was performed. The "ground truth" for this device's evaluation would be its adherence to engineering standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26) and its functional specifications, which are assessed via engineering tests, not clinical ground truth.
8. The sample size for the training set
- Not Applicable. This is hardware, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. (See point 8).
Summary of what is known from the document:
- Device Name: R-40 EEG Amplifier
- Intended Use: To acquire, store and transmit electrophysiological signals (wireless or cabled).
- Performance Evaluation Method: Primarily engineering safety testing (IEC 60601 series standards) and comparison of technical characteristics to a legally marketed predicate device (Nicolet Wireless EEG Amplifier, K103140).
- Clinical Testing: Explicitly stated as "not performed."
- Conclusion: The device meets functional claims and is substantially equivalent to the predicate device in terms of safety and effectiveness.
This type of 510(k) submission relies on demonstrating that a new device is "substantially equivalent" to an already legally marketed device, often through technical comparisons and adherence to recognized safety standards, rather than proving novel clinical performance against strict acceptance criteria in a clinical trial.
§ 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).