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The SOMATOM Emotion 16 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 translation of the patient. )

The Siemens SOMATOM Emotion 16 system is a 16 slice, whole body X-ray computed tomography systems, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The software is syngo-based Somaris/5 software version VB28, which is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

This document describes a 510(k) submission for the Siemens SOMATOM Project P10G (SOMATOM Emotion 16) Computed Tomography System. The submission details the device, its intended use, and its substantial equivalence to a predicate device.

However, the provided text does not contain any information regarding acceptance criteria, device performance, specific studies with sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

The document is a standard 510(k) summary for a medical imaging device (CT scanner) from 2005, which predates widespread AI/ML applications in medical devices and the specific types of studies and criteria currently expected for such technologies. The "software" mentioned (syngo-based Somaris/5 software version VB28) refers to the control and reconstruction software for the CT scanner itself, not an AI/ML algorithm for image analysis or diagnosis.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance for an AI/ML device based on the provided text. The requested information points to a type of regulatory submission and study design that is not present in this 2005 510(k) summary for a CT hardware system.

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Extended Field of View is part of the software module within the CT operating system and provides the selection and image reconstruction variable up to a fixed limit. As an option the limit has been extended up to 70 cm and the use of this special application requires a license key.

Extended Field of View is software package, which supports the selection and image reconstruction with variable targets. The maximum of visualization has been extended to the length of 70 cm2. Due to the extrapolation of the reconstructed data and the convolution with a suitable Fast Fourier Transformation this software package allows the desired extended Field of View (FoV).

This document is a 510(k) premarket notification for the "Extended Field of View (FoV) Software Package" for CT systems. It does not contain a study that proves the device meets specific acceptance criteria. This type of FDA submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials with detailed performance metrics against predefined criteria.

Therefore, many of the requested details such as a table of acceptance criteria and reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set information are not present in this document.

The core information conveyed is about the device's intended use and its substantial equivalence to previously cleared Siemens CT software packages.

Here's a breakdown of what can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance:

   • This document does not provide a specific table of acceptance criteria or quantitative performance metrics for the Extended Field of View software. The submission focuses on demonstrating substantial equivalence, implying that its performance is acceptable because it is similar to already cleared devices.

2. Sample size used for the test set and the data provenance:

   • Not applicable. This document is a 510(k) submission for software; it does not describe a test set or data provenance for a performance study.

3. 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 is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. No test set or adjudication is described.

5. 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:

   • No MRMC study is mentioned. The device is described as a software package for image reconstruction, not necessarily an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • No standalone performance study is described. The software acts as an option within the CT operating system for image reconstruction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable. No performance study requiring ground truth is described.

8. The sample size for the training set:

   • Not applicable. This document does not describe a machine learning model that would require a training set.

9. How the ground truth for the training set was established:

   • Not applicable. No training set is described.

In summary, this 510(k) document is a declaration of substantial equivalence for a software option (Extended Field of View) for CT systems. It details the device's name, classification, intended use (extending the visualization limit to 70 cm), and identifies predicate devices. It does not include information on specific performance studies, acceptance criteria, or detailed evaluations typically found in a clinical study report.

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