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The NeuroLink IP is intended to be used as an electroencephalograph: to acquire, digitize and transmit electroencephalographic and other physiological signals) for EEG studies in research and clinical environments.

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This document is a 510(k) clearance letter from the FDA for a device called NeuroLink IP, an electroencephalograph. The document specifies that the device model is PK1117 and is regulated under 21 CFR 882.1400.

The provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. The letter primarily addresses the substantial equivalence determination for the device, regulatory compliance, and general information for manufacturers.

Therefore, I cannot provide the requested information from the given text. A 510(k) clearance typically means the device is substantially equivalent to a previously cleared device, and often relies on demonstrating similar technological characteristics and performance to a predicate device, rather than requiring a detailed new clinical study with specific acceptance criteria outlined in the clearance letter itself.

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