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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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