(69 days)
Intended to record and display EEG and EP (evoked potential) data in the clinic and hospital. It is intended to aid in the diagnosis and monitoring of potential disorders of the central and peripheral nervous system.
Cognitrace provides a comprehensive EEG/ERP Data acquisition and analysis System. Cognitrace consists of the following components: 1 EEG/ERP amplifier, Power supply for EEG/ERP amplifier, eemagine EEG (K002631) software with Cognitrace extension modules, Stimulation unit. Cognitrace can perform complete sets of measurements for neurology and psychiatry: EEG, Visual Evoked Potential (VEP), Auditory Evoked Potential (AEP), P300 (Auditory oddball paradigm), Visual P300 (Visual oddball paradigm), CNV (Contingent Negative Variation), Option to add protocols using acoustic or visual stimulation. The software components are: eemagine EEG, a novel, user-friendly and efficient software package for the analysis of EEG data and eego, a novel, user-friendly EEG data acquisition system and allows you to record and review EEG, offering different amplifier configurations, eego is seemlessly integrated with the eemagine EEG software, which offers simplicity and efficiency in the analysis of EEG studies.
The provided text describes a 510(k) submission for the Cognitrace device, which is an electroencephalograph with evoked response stimulation. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way an AI/ML device would.
Therefore, many of the requested elements for an AI/ML device study (like sample size for test/training sets, ground truth establishment details, multi-reader multi-case studies, etc.) are not applicable and not present in this document.
However, I can extract the information that is available and present the "acceptance criteria" as implied by the substantial equivalence comparison to the predicate device.
Acceptance Criteria and Device Performance for Cognitrace (Based on Substantial Equivalence)
The Cognitrace device demonstrates its performance by showing substantial equivalence to a legally marketed predicate device, the Nicolet Bravo Multi Modality System (K991054). The "acceptance criteria" are implicitly defined by meeting or exceeding the specifications and functionalities of the predicate device, with a focus on safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Acceptance Criterion (from Predicate) | Cognitrace Performance (as Reported) | Notes/Comparison |
|---|---|---|
| Indications For Use | ||
| Record and display EEG, EP, EMG, TCD; aid in diagnosis/monitoring of central/peripheral nervous system and muscles. | Record and display EEG and EP (evoked potential) data; aid in diagnosis and monitoring of potential disorders of the central and peripheral nervous system. | Cognitrace has a slightly narrower stated indication (no EMG or TCD mentioned in the table), but it still addresses the core EEG and EP functions. The 510(k) conclusion explicitly states "no new indications for use". |
| Prescription Use | Yes | Same as predicate. |
| Testing Modes | ||
| EEG, EP, EMG | EEG, EP | Cognitrace supports EEG and EP. EMG is not listed as a supported mode for Cognitrace in the table. |
| Head Box | ||
| Uses a headbox; fewer channels (32) | Various headboxes available for up to 128 channels | Cognitrace offers more channels than the predicate. |
| Filters - Low Filter | ||
| First order IIR digital filter | Inside amplifier: Highpass: none | Different processing approach for low-frequency filtering. |
| Filters - High Filter | ||
| Second order IIR digital filter | Inside amplifier: Lowpass digital FIR filter, cutoff frequency = 0.27 * sample frequency | Different processing approach for high-frequency filtering. |
| Sample Frequencies |
§ 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).