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The intended use of our µEEG™ Pro System 5000 is for temporary recording of intractanial neural activity, temporary intracranial stimulation of neurons, and mapping of neural activity and evoked potentials.

uEEG™ Pro System 5000 Is indicated for use during intracranial neurophysiological recording and stimulation during deep brain stimulation, epilepsy surgery, and other procedures where it is appropriate to perform intracranial depth or subdural electrode recordings.

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I am sorry, but the provided text does not contain information about the acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) clearance letter from the FDA for the µEEG™ Pro System 5000, indicating that the device has been found substantially equivalent to a predicate device.

It primarily details:

• The FDA's decision to clear the device for marketing.
• The device's intended use, duration of use, and environment of use.
• The regulatory classification and general controls applicable to the device.
• Contact information for various FDA offices.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them based on the provided text.

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