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The SURGIVISIO medical device is intended to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical imaging and/or intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures include procedures during which the spine, pelvis or articulation structures are visualized.

The Surgivisio system is a mobile x-ray system which provides 2D imaging and allows the generation of intraoperative 3D information of high contrast objects and anatomical structures.
The system consists of two mobile interconnected units: a mobile C-arm and a mobile viewing Workstation. These units are moved manually and are interconnected by a single cable that provides power and transfer of data and controls.
The mobile C-arm comprises a high voltage generator, foot switches for radiation release, laser target devices, electronics cabinet, collision avoidance system, and a C-shaped structure mounting the X-ray tube assembly and the flat X-ray detector on distal ends of the 'C'.
The mobile viewing workstation comprises a computer, an image detector process unit, the main power supply, radiation indicator, dual viewing monitors and a user interface for patient management and image handling.
The system integrates a Computer Aided Surgery (CAS) feature that supports instruments positioning during surgical procedures.

The provided text describes the performance data for the Surgivisio system in relation to its substantial equivalence to a predicate device, the Arcadis Orbic. However, the document does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the format requested, particularly concerning AI/algorithm performance and human reader improvement.

Instead, the performance data section focuses on:

• Nonclinical tests: Primarily on compliance with various IEC standards for medical electrical equipment safety, radiation protection, and imaging quality assessment using phantoms. This includes 2D image quality assessment, basic CBCT bench testing, distortion phantom studies, 3D reconstruction algorithm characterization, and 3D image quality assessment with breathing simulation.
• Clinical images: Evaluation by a qualified expert to support the intended use of 2D and 3D imaging features.
• Radiation doses: Comparison to literature.
• Software Verification: Testing to ensure software requirements perform as intended.

The document explicitly states: "Clinical tests: No clinical tests were conducted to demonstrate substantial equivalence." This means there was no multi-reader multi-case (MRMC) comparative effectiveness study, nor a standalone algorithm performance study involving human-in-the-loop performance or the improvement of human readers with AI assistance. The "qualified expert" reviewing clinical images is not described in a way that allows for the detailed breakdown of ground truth establishment, sample size for the test set, number and qualifications of experts, or adjudication methods as requested for an AI/algorithm-focused study.

Therefore, I cannot provide the information in the requested format as the provided text does not contain the specific details regarding AI performance, human reader improvement, or the rigorous ground truth establishment methodology that would typically be associated with an AI/ML device approval study. The device, an X-ray imaging system, is cleared based on demonstrating substantial equivalence in its technical characteristics and image quality/safety, not on an AI/ML algorithm's diagnostic performance improving human readers.

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