(45 days)
To record the electroencephalogram (EEG) and evoked potentials (EP's) over extended periods of time such as during surgery and intensive care stays in order for trained health care professionals to observe changes.
The intended use of the Neurotrac II-EP is to monitor the electroencephalogram (EEG) and evoked potentials (EP's) over extended periods of time such as during surgery and intensive care stays in order to observe changes. The Neurotrac II-EP acts as a patient monitor as it displays EEG waveforms, performs calculations on the data and triggers alarms when user-defined limits are exceeded. In addition, the Neurotrac II-EP is an evoked potential measuring device designed to record and measure the brain stem and the somatosensory pathways in order to evaluate nervous system function. It stores monitored waveforms for retrospective on-screen review or for hard copy interpretation.
Use of the Neurotrac II-EP is indicated when electroencephalographic (EEG) and/or evoked potential (EP) monitoring is required during surgery or intensive care over extended periods of time.
The Neurotrac II-EP provides continuous monitoring of brain electrical activity (EEG) and monitoring of evoked electrical activity from the central and peripheral nervous system (EP). The system provides for recording of any combination of EEG/EP and displays the results. The system not only displays the raw EEG waveform but processes the EEG in ways which make it easier to detect changes in the amplitude and frequency of the signal. The amplitude and frequency of the signal are the two main characteristics of the EEG. In addition to displaying the EEG, the raw input of the EP waveform as well as it's average are displayed. The system processes the EP waveform which makes it easier to detect changes in the amplitude and latency of the signal. The amplitude and latency of the signal are the two main characteristics of the EP. The Neurotrac II-EP also provides clinicians the capability of reviewing collected data. All raw EEG and EP waveforms and computer processed information may be stored on an internal hard drive or a removable cartridge hard drive for retrieval at a later time. All data can be printed for immediate hard copy interpretation.
The Neurotrac II-EP is an enhanced version of the original Neurotrac II. The Neurotrac II-EP monitors brain function via the electroencephalogram (EEG) and via evoked potentials (EP).
The product will be sold as Neurotrac II-EP configured with hardware and software for both continuous EEG, auditory and somatosensory evoked potential monitoring. The amplifiers, processor unit and evoked potential stimulator of the Neurotrac II-EP system will be manufactured by Moberg Medical. These components are connected to the M1094 Display, manufactured by Hewlett-Packard (HP), to complete the basic Neurotrac II-EP system. The amplifiers are housed in a connecting box (headbox) which accepts one of several patented "Personality Cards (PCARD)". The electrode leadwires connect into the PCARD which shows the user where to connect the patient electrodes on the head and configures user defined monitoring procedures for different clinical applications. The PCARD only accepts electrodes with DIN 42 802 standard touch proof connectors. The evoked potential stimulator includes both auditory and electrical outputs. These are delivered to the patient by industry standard auditory headphones or tubephones and FDA approved electrodes for electrical stimulation. The electrical stimulator provides for six standard current level outputs and two low current level outputs. The low current level outputs are designed to be used with custom electrodes, provided with the Neurotrac II-EP. These custom electrodes provide for additional patient safety by prohibiting their use in standard higher current level outputs. A keyboard and mouse are provided for entry of alpha numeric information and changes with pull-down menus for parameters. Accessories to the product are a computer cart for portability, an audio-output for listening to electrical impulses from selected nerves or muscles, a manual switch box to select electrical outputs, a safety agency approved external storage device (i.e. hard drive, optical) and a PCL5 compatible printer for hard copy printouts.
The HP Display, Model M1094 provides the electrical power for the MMI processor, amplifiers, evoked potential stimulator and audio speaker.
This 510(k) summary (K960170) describes the Neurotrac II-EP, an enhanced version of the Neurotrac II. The Neurotrac II-EP is intended to monitor brain electrical activity (EEG) and evoked electrical activity (EP) from the central and peripheral nervous system over extended periods, particularly during surgery and intensive care.
1. A table of acceptance criteria and the reported device performance:
The provided 510(k) summary does not contain explicit quantitative acceptance criteria or a dedicated performance study with reported metrics for the Neurotrac II-EP. The submission primarily focuses on establishing substantial equivalence to predicate devices based on intended use, technological characteristics, and safety. It states that "There are no major differences that would alter intended use or jeopardize patient safety."
Therefore, a table of acceptance criteria and reported device performance cannot be generated from the provided text. The "acceptance criteria" appear to be implicit in meeting the functional and safety requirements comparable to the predicate devices.
2. Sample size used for the test set and the data provenance:
No specific test set or data provenance (e.g., country of origin, retrospective/prospective) is described in the provided text. The submission relies on a comparison to predicate devices rather than an independent performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
No information regarding experts or the establishment of ground truth for a test set is provided.
4. Adjudication method for the test set:
No information regarding an adjudication method is provided, as no specific test set is described.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
No MRMC comparative effectiveness study is mentioned in the provided text. The focus is on the device's inherent functionality and similarity to predicate devices, not on human reader performance with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The Neurotrac II-EP is a patient monitoring device that displays waveforms and processes signals for clinical interpretation by trained healthcare professionals. While it performs calculations and triggers alarms, it is not described as an autonomous diagnostic algorithm. Therefore, a standalone performance study in the context of an "algorithm only" is not applicable based on the provided information, and no such study is mentioned.
7. The type of ground truth used:
No specific type of ground truth (e.g., expert consensus, pathology, outcomes data) is mentioned as no explicit performance study with a test set is described. The "ground truth" for the device's functionality is implicitly derived from its ability to accurately record and process physiological signals consistent with established medical practice for EEG and EP monitoring, as demonstrated by its similarity to predicate devices.
8. The sample size for the training set:
No information regarding a training set or its sample size is provided. The device's design and functionality appear to be based on established engineering principles for medical devices and comparison to existing technologies, rather than a machine learning training paradigm.
9. How the ground truth for the training set was established:
Not applicable, as no training set is mentioned.
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).