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The Mobile X-ray Unit Sirius Starmobile tiara is a general radiography system and is composed of the X-ray high voltage generator, X-ray tube, support unit, and digital radiograph device (DR-ID 800) made by Fujifilm Corporation.

This device is designed for pediatric and adult patients.

It is intended for use in general radiography of the head, body, or extremities including pediatric exams. The device output can provide an aid to diagnosis when used by a qualified physician.

The Sirius Starmobile tiara battery powered, mobile x-ray system features a built-in Flat Panel Detector System: DR-ID800 which is a modification of the FDR D-EVO Flat Panel Detector System (DR-ID600), K132509. Because the Flat Panel Detector System is incorporated in the mobile equipment, the images are available to the technologist in a very short time, allowing the technologist to assure the exam has been performed adequately, minimizing return trips. Wireless communication is available, as an option, for updates to the patient worklist from the RIS/HIS.

The Sirius Starmobile tiara provides smooth and quiet motorized travel capability via rear wheels independently driven by dual motors, a versatile radiography range through the pantograph arm, and easy-to-operate positioning of flat detector providing sharp image quality with a short exam completion time.

The provided document is a 510(k) premarket notification letter for the Sirius Starmobile tiara, a mobile x-ray system. It does not contain information about acceptance criteria or a study proving its performance against such criteria for an AI/CAD/software device.

The document focuses on:

• Regulatory clearance: The FDA's determination of substantial equivalence to a predicate device (Carestream DRX-Revolution Mobile X-ray System, K120062).
• Device description and intended use: General radiography for head, body, or extremities for pediatric and adult patients.
• Non-clinical testing: Compliance with various IEC and AAMI ANSI standards related to medical electrical equipment, safety, electromagnetic compatibility, radiation protection, usability, and software life cycle processes.
• Technological characteristics comparison: Discussion of similarities and minor differences (e.g., target angle, anode heat capacity, detector pixel size) between the subject device and the predicate device, concluding overall substantial equivalence.
• Clinical testing snippet: Mentions "sample clinical images in Section 10 Performance" but provides no details on how they were used to define or meet acceptance criteria, study design, or metrics.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) as it is not present in the provided text. This document is a regulatory clearance letter, not a detailed performance study report.

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