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The Saturn 9000-750 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000-750 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000-750 is intended to be used in same clinical application as traditional film-screen based general radiography system.

The Saturn 9000-750 is equipped with a digital detector, X-ray generator interface, and image acquisition workstation. The digital detector is a-Se deposited plat panel detector. The input X-ray photons are absorbed in a-Se layer that creates an electrical charge which is representation of the Xray input. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. X-ray exposure is controlled by switch box, which also controls the acquisition timing of the detector. Saturn 9000-750 includes acquisition workstation ("AWB") monitor, keyboard and mouse, computer, electronics, and accessory storage resultant output signal can be transmitted to remote viewing sites, and/or it can be stored electronically for later viewing. The AWS is used for image acquisition, processing, and display. The AWS can also be used for database management and can send images to archive, review or filming.

This 510(k) summary describes a digital X-ray system, the Saturn 9000-750, which is intended for general X-ray imaging (not mammography). However, the provided document does not contain acceptance criteria or study data demonstrating that the device meets such criteria.

The document primarily focuses on:

• Identification of the device and submitter information.
• Comparison to a predicate device (Saturn 9000). This comparison highlights technical specifications, noting that the proposed device (Saturn 9000-750) has a larger imaging area (17" x 17" vs. 14" x 17") and a different detector pixel size (168µm vs. 139µm) but maintains the same a-Se direct technology, Se layer thickness, image bit depth, and software as the predicate.
• Indications for use, stating it generates digital X-ray images for general X-ray systems and is intended for the same clinical applications as traditional film-screen based general radiography systems.
• An FDA letter confirming substantial equivalence to legally marketed predicate devices, implying that the safety and effectiveness are established by its similarity to an already approved device, rather than through new performance studies detailed in this summary.

Therefore, I cannot provide the requested information in the table or answer questions 2-9 because the provided text does not contain any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert adjudication for this specific submission.

The FDA's substantial equivalence determination for this device (K072983) is based on its comparison to the predicate device (K063710). This means that the regulatory pathway relied on demonstrating that the new device is as safe and effective as the predicate, rather than requiring extensive new clinical performance studies with defined acceptance criteria to be submitted within this specific 510(k) summary. The performance of the predicate device would have been previously evaluated.

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