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The Mirage Release 5.5 system is indicated for the acquisition, processing, review and archiving of scintigraphy camera output data and related diagnostic images. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs.

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The provided text describes a 510(k) premarket notification for the "Mirage Release 5.5" device. However, this document is a regulatory approval letter and an Indications for Use statement. It does not contain details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information from the given text. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its regulatory clearance, but it does not elaborate on the specific performance studies that would typically be conducted to prove this equivalence.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed technical specification that includes the device validation and verification data.

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