(138 days)
The Compumedics Neuvo System is intended for measuring recording of the electrical activity of a patient's brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle/short- latency EP registration in the research environment. The system is intended to be used by qualified/trained EEG technologists and/or physicians. The data acquired must be interpreted by a qualified physician.
The Compumedics Neuvo System is intended for measuring of the electrical activity of a patient's brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle/short-latency EP registration in the research environment. The system is intended to be used by qualified/traincd EEG technologists and/or physicians. The data acquired must be interpreted by a qualified physician.
The Neuvo Amplifier System is an EEG/ERP/EP amplifier and data acquisition system. The amplifier and data acquisition clectronics are housed in a small enclosure (Headbox) placed near the patient, and into which individual clectrodes, collections of electrodes, may be connected. Additionally a high density electrode cap connector is provided on the Headbox. The Headbox also contains a connector for the interconnect cable to the System Unit.
The System Unit is slightly larger than the Headbox and serves as an interface between up to four Headboxes and the host computer.
The system operates under the software control of a host computer over an Ethernet 100BaseT interface. Data flows from the Neuvo amplifier over this interface.
Here's an analysis of the provided text regarding the Neuvo device's acceptance criteria and study, based on the information available in the 510(k) summary:
Unfortunately, the provided 510(k) summary for the Compumedics Neuvo (K081151) does not contain information about acceptance criteria or specific study results demonstrating performance for the device.
This document primarily serves as a submission for substantial equivalence to a predicate device (SynAmps2 510(k) # K023771) and focuses on describing the device, its intended use, and its classification. Performance data with acceptance criteria is typically detailed in separate sections of a 510(k) submission, such as a "Summary of Design Control Documentation" or "Performance Data," which are not present in the given excerpt.
Therefore, I cannot provide the requested information. The document focuses on:
- Administrative details: Contact person, date prepared, proprietary and common names, classification, and predicate device.
- Device description: Explanation of the Neuvo system components (amplifier, headbox, system unit, software control).
- Intended Use/Indications for Use: What the device is designed to do (measure electrical activity of the brain to aid in monitoring and diagnosis for EEG, and for EP registration in research).
- FDA correspondence: The letter confirming substantial equivalence.
Without further documentation from the 510(k) submission, it's impossible to answer the specific questions about acceptance criteria, study design, sample sizes, ground truth, or expert involvement.
§ 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).