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The intended use of the Opti-Amp DC-Powered is as a physiological signal amplifier. It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.

Opti-Amp DC-Powered is a bio-amplifier testing device (made up of a transmitter and receiver) that is capable of acquiring evoked potentials.

The provided text is a 510(k) summary for the Opti-Amp DC-Powered device, which is an evoked potential amplifier. It describes the device, its intended use, and its technological characteristics as compared to a predicate device.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The summary focuses on demonstrating substantial equivalence to a predicate device (Opti-Amp K914876) based on intended use and technological characteristics, specifically noting a change in power supply from batteries to a medical-grade power supply with additional protection. It does not include the type of performance data and studies requested in your prompt.

Therefore, I cannot provide the requested table and study details.

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