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The Ysio (New RAD -FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio system is not meant for mammography.

The Ysio uses an integrated or portable digital detector for generating diagnostic images by converting x-rays into electronic signals. Ysio is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.

The Ysio Radiography X-ray system is designed as a set of components such as ceiling suspension, bucky wall stand, bucky table, X-ray generator, X-ray tube, a portable wireless and a fixed detector, that may be combined into different configurations to provide specialized customer requirements.

The Ysio Radiography X-ray system is based on the currently available medical devices as listed in section 5.

The provided text is a 510(k) summary for the Siemens Ysio X-ray system. This document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance data for a new AI/CAD device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document, as it is not a study designed to evaluate a novel algorithm's diagnostic performance.

The document states that "all equipment is subject to final performance testing," but does not provide details of specific acceptance criteria or performance results from such testing. It primarily focuses on the device's intended use, description, and substantial equivalence to existing cleared X-ray systems.

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