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The C.A.R.E. VISION is intended to be used for instant display of CT images during interventional procedures using CT scanners. Instant image reconstruction of 3-9 images per second allows the physician to watch the placement of an interventional instrument real time.

The C.A.R.E. VISION option is a new scan mode added to the SOMATOM Plus 4 CT scanner. The option can be installed in the SOMATOM Plus 4 CT as an upgrade kit consisting of hardware, software and firmware. Under C.A.R.E. VISION, three to nine images are reconstructed and displayed per second, effectively simulating a real-time display presentation. More than one C.A.R.E. VISION scans can be set-up and performed one after the other. C.A.R.E. VISION can also be mixed with other scan modes. Switch to SEQUENCE scan mode can be initiated any time during C.A.R.E. VISION thus a particular phase of the operation can be displayed in enhanced image quality.

This document does not contain the information required to answer the request regarding acceptance criteria and device performance. The provided text is a 510(k) summary for the C.A.R.E. VISION Option for SOMATOM Plus 4 CT System, primarily focusing on its description, intended use, and substantial equivalence to predicate devices. It does not include:

• A table of acceptance criteria and reported device performance.
• Details about a test set, its sample size, or data provenance.
• Information on experts or ground truth establishment for a test set.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• The type of ground truth used.
• Training set sample size or ground truth establishment for a training set.

The document discusses the device's ability to reconstruct and display 3-9 images per second, effectively simulating real-time, and its use during interventional procedures to guide instrument placement. However, it does not provide quantitative performance metrics or studies to prove acceptance criteria.

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The SOMATOM Plus 4 CT Scanner is intended to produce crosssectional images of the body by computer reconstruction of X-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

• The axial planes resulted from the continuous rotation of detectors and X-ray tube and the simultaneous translation of the patient.

The SOMATOM Plus 4 with Somaris 4/B30 software is a whole body computed tomography X-ray scanner, which features a continuously rotating tube-detector system and functions according to the fan beam principle.

The provided text is a 510(k) Summary for the Siemens SOMATOM Plus 4 Computed Tomography (CT) Scanner with Somaris 4/B30 Software, submitted in 1996. This document describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices.

*However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot populate the table or answer the specific questions about performance studies. The 510(k) summary focuses on demonstrating equivalence to predicate devices based on design and technological characteristics, not on presenting detailed performance data from a specific study and acceptance criteria.

Key takeaway from the document regarding performance:

• Improved Low Contrast Resolution and Reduced Noise: The document states that the addition of an optional solid-state detector, which has a higher conversion efficiency than the previous xenon detector, "improves low contrast resolution and reduces image noise." This is a qualitative statement about performance improvement, but no specific metrics, acceptance criteria, or study data are provided to quantify this improvement.

In summary, based only on the provided text, the requested information about acceptance criteria and detailed study data is not available.

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