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510(k) Data Aggregation
(252 days)
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.
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(282 days)
The Blackrock NeuroMed Cervello Bio-Potential Signal Acquisition Product Family contains the following configurations.
Ambulatory: Up to 64 channels with one Cervello hardware device (Amplifier) using the Cervello software. The device is intended to acquire and store physiological signals for EEG and/or PSG, and to transfer the data to separate polysomnographic analysis software. The devices are intended to be used by physicians, technicians and other medical professions that are trained in EEG and/or PSG. The Cervello Ambulatory system does not make any judgment of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
Basic: Up to 64 channels with one Cervello hardware device (Amplifier) and up to 128 channels by cascading 2 Cervello devices using the Cervello software. The device is intended to acquire and store physiological signals for EEG and/or PSG, and to transfer the data to separate polysomnographic analysis software. The devices are intended to be used by physicians, technicians and other medical professions that are trained in EEG and/or PSG. The Cervello Basic system does not make any judgment of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
Elite: Up to 128 with one Neuroport Bio-Potential Recording Systems and up to 256 by cascading two Neuroport systems using the Central and/or Cervello software. The system supports recording, processing and display of biopotential signals from user-supplied electrodes. Bio-potential signals include: Electrocorticography (ECGG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP). Intended users include Physicians, clinicians or other medical professionals that are trained in bio-potential and/or EEG recording. The Cervello Elite system does not make any judgment of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
Multi-Channel, Multi-Modal Physiological Monitoring System
Cervello Ambulatory - This system uses the Cervello Amplifier in the ambulatory environment and provides up to 64 input channels for EEG and PSG studies. The Amplifier is battery powered during recording; the internal microcontroller stores the data in a RAM buffer and memory card where it can be downloaded later for review by a physician.
Cervello Basic - This is a PC-based clinician-oriented EEG and/or PSG monitoring system that provides between up to 128 channels for EEG recording using the Cervello Amplifier. Data is displayed on a monitor using the Cervello Basic software program and video capabilities are available.
Cervello Elite -- This is a PC-based clinician-oriented monitoring system that provides up to 256 channels for recording bio-potentials such as electroencephalography (EEG), electromyography (EMG), electroencephalography (ECG), electrooculography (EOG), electrocorticography (ECoG) and evoked potential (EP) using the NeuroPort Bio-Potential System Hardware and operates both the Cervello (Basic) and the Central Software. Video capabilities are available.
In all cases, and as with the predicate devices, the Cervello Basic, Ambulatory and Elite Systems are not monitoring systems. No physiologic alarms are provided. The acquisition and display of bio-potential signals is for the interpretation and use of the clinician. The devices do not make any judgment of normality or abnormality of the displayed signals and the software is not intended to do automatic analysis of the recorded signals
The Blackrock NeuroMed Cervello Bio-Potential Signal Acquisition System is a multi-channel, multi-modal physiological monitoring system with three configurations: Cervello Ambulatory, Cervello Basic, and Cervello Elite. The submission for this device is a consolidation/modification of existing devices, and its acceptance criteria and the study proving it meets these criteria are based on its substantial equivalence to predicate devices. The device is not intended to make any judgment of normality or abnormality of the displayed signals, nor is it a monitoring system with physiological alarms. Its purpose is to acquire, display, store, and archive bio-potential signals for interpretation and use by clinicians.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Cervello Bio-Potential Signal Acquisition System are generally aligned with the performance characteristics of its predicate devices, as the submission aims to demonstrate "substantial equivalence." The performance is deemed acceptable if it matches or is comparable to the predicate devices.
| Feature | Acceptance Criteria (from Predicate Devices) | Reported Device Performance (Blackrock NeuroMed Cervello) | Justification for Equivalence |
|---|---|---|---|
| Intended Use Environment | Clinics, hospitals, operating rooms, epilepsy evaluation unit environments, sleep laboratories, medical facility, physician's office, laboratory, clinic or nursing home. | Same/equivalent clinical environments. | Same/equivalent clinical environments. Therefore, Substantially Equivalent. |
| Target Patient Population | All patient populations (or not stated, implying general applicability). | Adults and pediatrics / The device will be available on all patient populations as determined by a trained professional. | Same/equivalent patient populations. Therefore, Substantially Equivalent. |
| Use Limitations | Not a monitoring system, no physiologic alarms, no judgment of normality/abnormality, acquisition and display for clinician interpretation. | Same limitations. | Same/equivalent use limitations. Therefore, Substantially Equivalent. |
| Bio-Potential Signals Recorded | EEG, ECoG, ECG, EMG, EOG, EP, Video EEG, Respiration, Heart rate, SPO₂. | All listed signals, plus Respiration, Heart rate, SPO₂ for some configurations. | Same/equivalent bio-potential recordings. Therefore, Substantially Equivalent. |
| Clinical Applications | Bio-potential signal amplification, recording, display, digitization, retrieval and display. Acquisition of bioelectric signals for neurophysiological exams. | Same applications. | Same/equivalent clinical applications. Therefore, Substantially Equivalent. |
| Number of Signal Recording Channels | Up to 128 (one device) / Up to 256 (cascading). | Up to 128 (one device) / Up to 256 (cascading) (Elite); 64 or 128 (Basic); 64 (Ambulatory). | Equivalent number of channels obtained via daisy-chaining. Therefore, Substantially Equivalent. |
| Analog Input Channels (per unit) | 16 or 24. | 16 (Elite); 24 (Basic/Ambulatory). | Same/equivalent number of analog channels per unit. Therefore, Substantially Equivalent. |
| Amplifier Input Impedance | 1000 Megohm or >10⁸ Ω (diff); >5*10⁸ Ω (CMII). | 1000 Megohm or >10⁸ Ω (diff); >5*10⁸ Ω (CMII). | Collectively, identical to predicates; therefore, Substantially Equivalent. |
| Amplifier DC Signal Range | ± 500 mV or 1V (15µV/digit). | ± 500 mV or 1V (15µV/digit). | Collectively, identical to predicates; therefore, Substantially Equivalent. |
| Amplifier Frequency Response | 0.3 to 7.5 kHz or 0.15 - 220 Hz. | 0.3 to 7.5 kHz or 0.15 - 220 Hz. | Collectively, identical to predicates; therefore, Substantially Equivalent. |
| A/D Conversion | 16 bit. | 16 bit. | Collectively identical to predicates; therefore, Substantially Equivalent. |
| Sampling Rate | Up to 30,000 Hz or 8192 Hz per channel. | Up to 30,000 Hz or 8192 Hz per channel. | Collectively, identical to predicates; therefore, Substantially Equivalent. |
| CMRR | > 90 dB or >100dB@20Hz. | > 90 dB or >100dB@20Hz. | Collectively, identical to predicates; therefore, Substantially Equivalent. |
| Noise | < 3 µVrms or < 0.5µV r.m.s.@256Hz sampling rate. | < 3 µVrms or < 0.5µV r.m.s.@256Hz sampling rate. | Collectively, identical to predicates; therefore, Substantially Equivalent. |
| Power Source | 120 VAC or 2x 1.5V DC AA alkaline batteries. | 120 VAC or 2x 1.5V DC AA alkaline batteries. | Collectively, identical to predicates; therefore, Substantially Equivalent. |
| Software | Central, Cervello, or equivalent. | Cervello and Central. | Uses same software as the predicate devices; therefore substantially equivalent. |
| Video Camera | Available (or not stated). | Available. | Uses same video camera running through the Cervello software; therefore substantially equivalent. |
| Alarms | No. | No. | Collectively, identical to predicates; therefore, Substantially Equivalent. |
| Operating System | Windows XP, 7, Server 2008 R2, 150 MHz or 2 GHz processor. | Windows XP, 7, Server 2008 R2, Dual Core 2 GHz Processor. | PC Environment updated per new standard operating systems; therefore, Substantially Equivalent. |
| Safety Standards Compliance | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26. | IEC 60601-1:1998, IEC 60601-1-2:2007, IEC 60601-2-26: 2002. | Same/equivalent safety standards. Therefore, Substantially Equivalent. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not detail specific sample sizes for test sets in clinical studies. The performance testing primarily focused on demonstrating substantial equivalence to predicate devices through technical specifications and compliance with standards.
- Sample Size for Test Set: Not explicitly mentioned in terms of patient data. The evaluation appears to be based on engineering and performance testing against established standards and comparison to predicate devices, rather than a clinical trial with a specific patient test set.
- Data Provenance: The document does not mention data provenance in terms of country of origin or whether studies were retrospective or prospective, as the device's approval is based on substantial equivalence and technical performance, not new clinical data generation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
No information regarding experts establishing ground truth for a test set is provided. The submission relies on technical comparisons to predicate devices and adherence to regulatory standards (e.g., IEC 60601) to support its claims of safety and effectiveness.
4. Adjudication Method for the Test Set
Not applicable, as no dedicated test set requiring clinical adjudication is described in the provided information.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a bio-potential signal acquisition system, not an AI-assisted diagnostic tool that would typically be evaluated with an MRMC study for human reader performance improvement. It does not provide automatic analysis or diagnostic judgments.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a hardware and software system for acquiring and displaying bio-potential signals; it does not contain an AI algorithm that operates standalone for diagnostic purposes. The software is explicitly stated "not intended to do automatic analysis of the recorded signals" and "not intended for use as an automated apnea monitor."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by its adherence to internationally recognized electrical safety and performance standards (e.g., IEC 60601 series) and by demonstrating that its technical specifications and intended use are equivalent to existing, legally marketed predicate devices. This is a regulatory "ground truth" rather than a clinical one derived from patient outcomes or expert consensus on a specific diagnostic task.
8. The sample size for the training set
Not applicable. The device is not a machine learning or AI model, so there is no "training set" in the conventional sense. Its design and validation are based on engineering principles and regulatory compliance.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model. The evaluation of this device is based on comparing its specified performance characteristics and safety profiles to those of legally marketed predicate devices.
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