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EOSedge is intended for use in general radiographic exams and applications, excluding the evaluation of lung nodules and exams involving fluoroscopy, angiography, and mammography. EOSedge allows the radiographic acquisition of either one or two orthogonal X-ray images, for diagnostic purposes, in one single body or a reduced area of investigation of a patient, in the upright or seated position.

The Micro Dose feature is indicated for assessing global skeletal deformities in follow-up pediatric exams.

The EOSedge system is a digital radiography system comprised of an acquisition workstation, a gantry including an electrical cabinet housing the system power and communication controls, and an acquisition software to obtain diagnostic images. Two sets of detectors and X-ray tubes are positioned orthogonally to generate frontal and lateral images simultaneously by scanning the patient over the area of interest. If desired, the Micro Dose feature enables image acquisition for assessing global skeletal deformities in follow-up exams. The diagnostic images are stored in a local database and are displayed on a highresolution medical-quality non-diagnostic image can be transmitted through a DICOM compatible digital network for printing and archiving.

The provided text is a 510(k) summary for the EOS imaging's EOSedge System. It describes the device, its intended use, and compares it to a predicate device (EOS System K152788) to demonstrate substantial equivalence.

However, the document does not contain information about acceptance criteria for an AI/algorithm's performance, nor does it describe a study that proves a device meets such criteria. It focuses on the substantial equivalence of an X-ray imaging system to its predecessor, based on design, technical specifications, and general performance testing (bench testing for dosing and image quality).

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving an AI device meets them based on the provided text. The document is about a conventional X-ray imaging system, not an AI-driven device with specific performance metrics like sensitivity, specificity, or AUC established through clinical studies with ground truth.

The "Performance Data" section (page 4) states: "Bench performance testing were conducted based on FDA's Guidance for the Submission of 510/k)'s for Solid-State X-ray Imaging Devices (September 1, 2016), to verify that EOSedge performs according to specifications and is as safe and effective as the predicate device." This refers to engineering and image quality tests common for X-ray hardware, not an AI algorithm evaluation.

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