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The Direct Radiography™ device provides a digital image capture capability for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The device has application wherever conventional screen-film systems are currently used.

The Sterling Diagnostic Imaging Direct RadiographyTM device is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a digital network for diagnostic viewing and printing. The device provides digital image capture for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The Direct RadiographyTM device differs from traditional X-ray systems in that instead of exposing a film for subsequent wet chemical processing to create a hardcopy image, a device called a digital array is used to capture the image in electronic form. The digital data are then used to produce hardcopy and softcopy images.

The provided document is a 510(k) summary for the "Sterling Diagnostic Imaging Direct Radiography™" device. This device is described as a system to directly capture and convert conventional projection X-ray images to digital images.

However, the document does not contain information regarding detailed acceptance criteria, specific device performance metrics, or any studies demonstrating that the device meets such criteria.

The document primarily focuses on:

• Device Description: What the device is and how it works (digital image capture instead of film).
• Intended Use: For conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications) wherever screen-film systems are currently used.
• Predicate Device Comparison: It compares the digital nature of the Sterling device to the analog nature and chemical processing of traditional screen-film systems, concluding substantial equivalence for conventional radiographic examinations.
• FDA Clearance Letter: A letter from the FDA stating that the device is substantially equivalent to the predicate and can be marketed.

Since the document is a 510(k) summary, it aims to establish substantial equivalence to a predicate device rather than providing extensive performance studies with detailed acceptance criteria typically found in clinical trial reports or technical specifications for newer, novel devices. The determination of "substantially equivalent" implies that the new device is as safe and effective as a legally marketed predicate device, and thus, extensive de novo performance studies with separate acceptance criteria might not have been required or documented in this specific submission summary.

Therefore, I cannot provide the requested information from the given text.

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