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The Galiteo Halley Electroencephalograph is intended for use in acquiring and storing bioelectric signals produced by brain activity for the diagnosis and prognosis of neurological disease.

The GALILEO HALLEY option is an intelligent patient box (fig. 1), able to work both in connection with a GALILEO station or as stand-alone. Therefore it includes the amplification, filtering, sampling, A/D conversion and data transmission functions, which in the other GALILEO stations are performed by the umplified patient box and by the GALILEO ACQ board. In the stand-alone mode HALLEY also memorizes the acquired data in GALILEO standard file format; in the other GALILEO stations the operative system of the PC itself accomplishes this operation.

The ESAOTE Galileo Halley Biosound Essote (K970703) is an electroencephalograph (EEG) device intended for acquiring and storing bioelectric signals produced by brain activity for the diagnosis and prognosis of neurological disease.

This submission is a 510(k) premarket notification, which means the device is seeking clearance based on substantial equivalence to a predicate device, rather than requiring extensive clinical trials for a new device. The provided document does not contain a study explicitly designed to "prove" the device meets acceptance criteria in the way a clinical trial would. Instead, the "study" is a comparison to predicate devices, demonstrating that the Galileo Halley has similar technical specifications and intended use, implying comparable safety and effectiveness.

Here's an breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the technical specifications of the predicate devices, and the reported device performance indicates that the Galileo Halley meets or exceeds these.

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