Search Results

BE Plus PRO and Neurotravel LIGHT are intended to be used for Electroencephalography (EEG) and Polysomnography (PSG) exams, in combination with the Galileo NT Line software, for human beings to assist the user in diagnosis and monitoring of disorders of the central and peripheral nervous system and muscles.

EEG Family devices (BE plus PRO and Neurotravel LIGHT) are active medical devices composed of various parts necessary to allow the achievement of their intended use. All these parts are intended to be interconnected to achieve the specified medical purpose.

EEG Family devices can be used in patients, diagnostics centers, neurosurgical hospitals and experimental laboratories of research institutions.

EEG Family devices are capable of acquiring the bioelectric signal generated by the electrical potentials of the neurons of the cerebral cortex, by means of suitable signal, stimulus electrodes. This signal, of the order of a first and then, filtered to claim it of noise and offset. It is then digitized by a high-resolution analog-to-digital converter at a certain sampling rate.

The signals acquired and converted into digital format are transferred to a Host PC through a special serial communication with a dedicated protocol and then can be processed by the Galileo NT software to complete the intended use.

The software part allows the implementation of many specific functions of visualization, measurement, processing and storage of brain signals, acquired by the acquisition unit, based on the clinical area of interest.

EEG Family devices are offered in the following two configurations:

• Mobile: All components are mounted on a mobile trolley.
• Portable: All components are mounted on a stationary desktop.

The provided text describes specific details about device performance relative to established standards. However, it does not contain information about a study designed to evaluate acceptance criteria in the context of diagnostic accuracy, human reader performance, or clinical outcomes. The "acceptance criteria" presented are primarily related to safety and electromagnetic compatibility standards, rather than performance metrics like sensitivity, specificity, or reader agreement.

Based on the provided text, here's an analysis:

Acceptance Criteria and Device Performance (Safety and EMC)

Missing Information (Not Available in Provided Text):

The provided text focuses on demonstrating substantial equivalence based on safety and performance standards for an amplifier and software, not on evaluating a diagnostic algorithm's accuracy against a ground truth or its impact on human reader performance. Therefore, the following requested information is not present in the given document:

• Sample size used for the test set and the data provenance: Not applicable to the type of testing described (safety and EMC).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a physiological signal amplifier and analysis software, not an AI-based diagnostic aid that directly improves human reader performance in a comparative study.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The "software" component seems to be for signal processing, visualization, and measurement, not a diagnostic algorithm that would have standalone performance metrics like sensitivity/specificity.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to safety and EMC testing.
• The sample size for the training set: Not applicable. These are hardware (amplifier) and signal processing software, which typically don't have "training sets" in the AI/machine learning sense.
• How the ground truth for the training set was established: Not applicable.

Summary of the Study Performed:

The study performed was a non-clinical performance evaluation focusing on the physical and operational aspects of the BE Plus PRO and Neurotravel LIGHT devices (physiological signal amplifiers and associated software).

• Objective: To verify the electrical/mechanical/thermal safety and electromagnetic compatibility (EMC) of the subject devices, particularly due to enhancements made to electrical components compared to their predicate devices.
• Methodology: The evaluation was conducted using the exact same test methods as those used for the predicate devices, adhering to FDA-recognized external standards:
  • ANSI/AAMI ES60601-1 (Electrical, Mechanical, and Thermal Safety)
  • IEC 60601-2-26 (Specific to EEG equipment, for BE Plus PRO)
  • IEC 60601-1-2 (Electromagnetic Compatibility)
  • IEC 62304 (Medical Device Software)
  • ISO 14971 (Medical Device Risk Management)
• Results: The subject devices "passed all requirements of these standards. No deviations or exceptions were encountered."
• Conclusion: The manufacturer concluded that the subject devices "do not introduce any new safety considerations in comparison to the predicate devices. All identified differences between the two systems are minor and without any known impact on safety or efficacy."

This type of study is typical for demonstrating substantial equivalence for hardware devices and their accompanying software in terms of safety and basic functionality, rather than complex diagnostic AI performance.

Ask a specific question about this device