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The SOMATOM Plus 4 with Sliding Gantry Option is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes* taken at different angles. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous movement of the sliding gantry.)

The SOMATOM Plus 4 with Sliding Gantry Option is a whole body X-ray computed tomography scanner that features a continuously rotating tube-detector system and functions according to the fan beam principle. The Sliding Gantry Option integrates the function of precise scan control driven horizontal movement, which is usually a function of the dedicated CT-table, into the CT gantry itself. This is achieved by mounting the gantry on a dedicated rail system and by having a scan control system that moves the gantry relative to the table instead of moving the table relative to the gantry.

The provided text is a 510(k) summary for the SOMATOM Plus 4 with Sliding Gantry Option, a Computed Tomography (CT) system. It focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through a rigorous evaluation of its imaging capabilities.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size for the test set or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study or its effect size.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is primarily concerned with regulatory approval based on technological equivalence to existing, legally marketed CT systems, rather than a clinical performance study with specific quantitative acceptance criteria for image quality or diagnostic accuracy. It states that:

• The device is substantially equivalent to the Angio-CT MIYABI (K990491) and SOMATOM Project 059 (K941546).
• It operates with SOMARIS/4 software.
• It adheres to recognized and established industry practices to minimize electrical, mechanical, and radiation hazards.
• It is designed to meet ELECTRICAL AND MECHANICAL SAFETY STANDARD IEC 601-1 and UL 187 X-RAY EQUIPMENT STANDARD FOR SAFETY.
• It is certified to meet the Federal Diagnostic Equipment Performance Standard and applicable regulations of 21 CFR § 1020.30 and § 1020.33.

These are regulatory and safety compliance standards, not specific performance criteria related to diagnostic accuracy or image quality that would typically be evaluated in a study with a test set, ground truth, and expert readers.

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