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The Oasis system is indicated for the processing and review of scintigraphy data and other related diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations. Oasis is capable of processing and displaying the medical image data 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. The Oasis system displays the processed images using an integrated computer. Oasis provides manual and automatic report creation plus the ability to view these reports remotely. Oasis also provides patient scheduling tools. This device is not used in the primary diagnosis of Mammography images.

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This document is a 510(k) clearance letter for the Oasis, Release 1.0 device, which is a Picture Archiving and Communication System (PACS). This type of document typically provides regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.

The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is typically found in the 510(k) submission summary or in the actual performance studies conducted by the manufacturer, which are not directly part of this FDA clearance letter.

Therefore, based solely on the provided text, I cannot extract the detailed information requested regarding acceptance criteria and the study that proves the device meets them. The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance is considered acceptable relative to those devices, but it does not specify performance metrics or the studies used to establish this equivalence in detail.

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