Search Results

The Cervello® STIM cortical stimulator is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG).

The stimulation is applied to the brain using third-party stimulation probes (including cortical or intracranial electrodes) and the resulting cortical or deep brain potentials themselves are recorded using third-party cortical or intracranial electrodes.

The Cervello® STIM itself is an accessory to the Cervello® Basic Biopotential Signal Acquisition System. The stimulation parameters, the election and the activation of the stimulation current are all set-up and controlled from it. The Cervello® STIM can operate only when so connected and with the Cervello software; it cannot serve as a stand-alone cortical stimulator.

The Cervello® STIM cortical stimulator is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG). The stimulation is applied to the brain using third-party stimulation probes (including cortical or intracranial electrodes) and the resulting cortical or deep brain potentials themselves are recorded using third-party cortical or intracranial electrodes. The Cervello® STIM itself is an accessory to the Cervello® Basic Biopotential Signal Acquisition System. The stimulation parameters, the election and the activation of the stimulation current are all set-up and controlled from it. The Cervello® STIM can operate only when so connected and with the Cervello software; it cannot serve as a stand-alone cortical stimulator.

I am sorry, but the provided text is a 510(k) summary for the Cervello® STIM cortical stimulator. It focuses on demonstrating substantial equivalence to predicate devices, but does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The document primarily provides a comparison of technological characteristics between the Cervello® STIM and other predicate devices, along with adherence to recognized consensus standards. It does not detail specific clinical or performance studies with acceptance criteria and results.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the information given.

Ask a specific question about this device

The Neuromaster G1 MEE 2000 Neural Function Measuring System is intended to monitor, record, and display the bioelectric signals produced by sensory and motor pathways in the operating room, critical care, and other areas where continuous monitoring is needed. The system measures and displays electric/auditory/visual evoked potential (EP), electroencephalography (EEG), and electromyography (EMG), skin temperature of distal portion of extremities, SpO2, and ETCO2 to provide health care professionals with information to help assess a patient's neurological status. The system is used as a nerve stimulator for surgical procedures and brain mapping during treatment of patients with seizure disorders and used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

· EEG - The device may also measure and record the electrical activities of the patient's brain obtained by placing two or more electrodes on the head (EEG).

· EP-Electrical/ Auditory/ Visual - Continuous and/or periodic measurements of evoked potential activities are displayed and stored. The device applies an electrical stimulus to a patient through commercially available skin electrodes for the purpose of measuring the evoked response. The photic stimulator is used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye and the auditory stimulator produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

· Free Run EMG - The Free Run EMG function identifies spontaneous EMG activity of nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.

· CoMEP - Cortical stimulation techniques for cortical mapping are used at "Low Output" for placement of electrodes during surgical procedures and for brain mapping during treatment of patients with seizure disorders.

· TcMEP - Transcranial electrical stimulation techniques for motor evoked potentials (TcMEP) are used at "TcMEP Output" for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency."

· Nerve conduction study - The device is intended to measure and display nerve conduction time by applying a stimulus to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

• SpO2 - When the SpO2 adapter and finger and toe probe for SpO2 measurement are used. oxygen saturation information is automatically measured and displayed.

· EtCO2 - When the CO2 adapter and sensor for EtCO2 measurement are used, endtidal carbon dioxide of respiratory gas information is automatically measured and displayed.

• Skin temperature - When the skin temperature sensor for skin temperature measurement is used, skin temperature information is automatically measured and displayed.

· Remote reader – The remote reader function provides real time remote access to the system for a monitoring physician outside of the operating room.

The device is intended for use by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional.

The device is available for use on any patient as determined by the medical professional including adults and children of all ages.

The Neuromaster G1 MEE2000 Neural Function Measuring System is a compact and multi-functional system for continuous monitoring of brain and neural pathways intraoperatively and in critical care areas. The system measures and displays electric/auditory/visual evoked potential (EP), electroencephalography (EEG), and electromyography (EMG), skin temperature of distal portion of the extremities, SpO2 and ETCO2. The system also measures and displays nerve conduction time by applying a stimulus to a patient's peripheral nerve. The system includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

The system uses electrical stimulus, visual stimulus, or sound stimulus in evoked responses measurements (EP). Continuous and/or periodic measurements of evoked potential activities are displayed and stored. The system applies an electrical stimulus to a patient through skin electrodes for the purpose of measuring the evoked response. The photic stimulator is used to generate and display a shifting light pattern or to apply a brief light stimulus for use in evoked response measurements or electroencephalogram activation. The system may measure and record the electrical activities of the patient's brain obtained by placing two or more electrodes on the head (EEG).

The system can be used as a nerve stimulator for surgical procedures and brain mapping during treatment of patients with seizure disorders and used for intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

The system can be connected to SpO2 and ETCO2 sensors to display the patient's oxygen saturation values as measured by pulse oximetry and CO2 values respectively throughout the procedure.

The acquired waveforms are displayed in cascaded format and measurement data may be displayed on the trend graph with waveform annotations (events). The acquired waveforms with the measurement data can be saved to a large capacity storage media. The data can be printed directly on paper, printed to portable document format (pdf), and/or archived to other locations.

The Neuromaster G1 MEE2000 System consists of at minimum a main unit (DC-200B), an amp unit (JB-232B), one breakout box (JB-210B), four stimulation pods [JS-201B(A), JS-202B (B), JS-203B (C), JS-204B (D)], and a computer (CC-201BK) with specific software. There are several standard and optional accessories such as cables, connectors, SpO2 probes, ETCO2 sensors, and various types of electrodes and leads.

Here's a breakdown of the acceptance criteria and study information for the Neuromaster G1 MEE2000 Neural Function Measuring System, as derived from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting novel acceptance criteria and explicitly defining the new device's performance against them. Instead, the performance characteristics of the Neuromaster G1 MEE2000 System are presented in comparison to its predicate device (Neuromaster MEE1000 System) and other reference predicates. The "acceptance criteria" here are implicitly the performance specifications of the predicate devices, which the new device aims to meet or exceed where noted.

I will present a selection of key characteristics to illustrate this comparison format. Please note that the document contains a very extensive table (Table 3) outlining numerous characteristics; this is a summary of some of the most relevant ones to demonstrate the device's technical specifications and how they align with or improve upon predicates.

Table: Acceptance Criteria (Predicate Performance) and Reported Device Performance (Neuromaster G1 MEE2000)

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No animal or clinical studies were necessary for Neuromaster G1 MEE2000 Neural Function Measuring System." This indicates that there was no "test set" in the traditional sense of human or animal subjects for performance evaluation for the 510(k) submission. The data provenance is therefore not applicable in this context as no clinical data was generated for this submission. The evaluation was primarily based on engineering verification and validation testing, and comparison to predicate devices' established performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as no clinical studies with human or animal test sets were conducted. The "ground truth" for the device's technical specifications was established through engineering design, calculations, and adherence to relevant industry standards (e.g., IEC 60601-1, IEC 60601-2-40), rather than expert consensus on clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable, as no clinical studies requiring ground truth adjudication from experts were conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance

Not applicable. The Neuromaster G1 MEE2000 is a neural function measuring system, not an AI-assisted diagnostic or interpretation tool that would involve human readers interpreting cases. It monitors, records, and displays bioelectric signals, but does not provide automated diagnoses or interpretations that would be subject to MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is a measurement and monitoring system, designed for use by medical personnel. It is not an "algorithm-only" device that operates without human interaction or interpretation of the displayed data.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is intrinsically linked to its technical specifications and safety standards. This includes:

• Engineering Specifications: Adherence to design parameters for signal amplitude, noise levels, filter characteristics, stimulation intensity, etc.
• International Standards: Compliance with recognized standards such as IEC 60601-1 (electrical safety), IEC 60601-2-40 (electrical medical equipment for electromyographs and evoked response equipment), and 21 CFR Part 898 (Performance Standard for Electrode Lead Wires and Patient Cables).
• Predicate Device Performance: The established operating characteristics and proven safety and effectiveness of the legally marketed predicate devices (primarily Neuromaster MEE1000 System), which the new device demonstrates substantial equivalence to.

8. The Sample Size for the Training Set

Not applicable. As indicated in point 2, no animal or clinical studies were necessary. This device is not an AI/machine learning device that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set for this device.

Ask a specific question about this device