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The system is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.

The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

The proposed device Revolution Ascend Sliding is a head and whole-body CT system composed of a gantry, transporter, operator console with a host computer, power distribution unit, and interconnection cables. The system also includes image acquisition and reconstruction hardware/software, general system software, accompanying documents, and associated accessories/interconnections.

Revolution Ascend Sliding generates cross-sectional images of the body by computer reconstruction of xray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions modes.

The provided text does NOT include details about acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.

Here's why and what information IS available:

This device is a Computed Tomography (CT) X-ray System, specifically a hardware modification. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Revolution Ascend, K213938) based on engineering design, performance, and image quality specifications. It's not an AI/CADe device that would typically have the kind of performance metrics (sensitivity, specificity, AUROC) and associated study designs you're asking for.

Therefore, most of the requested fields cannot be filled from this document.

Here's what information I can extract and why other fields are not applicable:

• A table of acceptance criteria and the reported device performance: This detail is not provided. The document states that the device "maintains the identical/equivalent performance and image quality specifications" to its predicate and that "Non-clinical bench test results demonstrated the subject device performs equivalently to the predicate device." However, specific numerical acceptance criteria and reported performance values for those criteria are not listed.
• Sample sized used for the test set and the data provenance: Not applicable in the context of this document. This is not a study evaluating diagnostic performance on a dataset of patient cases. The testing mentioned is "engineering design V &V and bench testing."
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment by experts is described for a diagnostic performance study.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable. No training set is mentioned as this isn't an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

What the document does state about testing and compliance:

• Testing Philosophy: The device was tested through "engineering design V &V and bench testing" to demonstrate substantial equivalence to the predicate device.
• Compliance: The device is "in compliance with AAMI/ANSI ES 60601-1 and IEC60601-1 Ed. 3.2 and its associated collateral and particular standards, 21 CFR Subchapter J, and NEMA standards XR 25, XR 26, and XR 28."
• Image Quality Testing: Image quality testing was done "in accordance with IEC 61223-3-5 ed.2 to demonstrate the overall system performance in a standardized and referenceable manner."
• Clinical Testing: "The Revolution Ascend Sliding CT system can be fully tested on the engineering bench thus no additional clinical testing was required." This indicates that the regulatory body agreed that bench testing was sufficient to demonstrate safety and effectiveness for this type of device modification.
• Quality Assurance Measures: Includes "Risk Analysis and Control, Required Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification)."

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