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The NeuroPort™ Array System (Neuroport Electrode) is intended for temporary (

The NeuroPort™ Array System (Neuroport Electrode) is comprised of a base approximately 4 mm x 4 mm dimensionally with 100 microelectrodes. Each microelectrode is approximately 1 mm long. The lead connects the microelectrode array to the percutaneous pedestal connector.

The request asks for a description of acceptance criteria and the study proving the device meets those criteria, based on the provided text. However, the provided text is a 510(k) summary and FDA clearance letter for the NeuroPort™ Cortical Microelectrode Array System, largely relying on substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for the new device.

Therefore, many of the requested sections (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, specific performance metrics beyond biocompatibility and recording electrical activity) are not explicitly available in the provided document.

Here's the information that can be extracted or reasonably inferred from the text:

1. A table of acceptance criteria and the reported device performance

Based on the 510(k) summary, the core "acceptance criteria" are implied by the performance data, which aims to demonstrate substantial equivalence to the predicate device.

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