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The SOMATOM P45 is intended to produce cross-sectional images of the body by The SOMA TOM 145 13 medical vary ... at different angels or spiral planes* taken at different angles.

(*spiral planes: the axial planes resulting from the continuous rotation of detectors and xray tube, and the simultaneous translation of the patient.)

The Siemens SOMATOM P45 is a whole body X-ray computed tomography system, which I he Slement SOMATON 1-19-15 a wills and functions and functions according to the fan assisted teatures two continuously routing is a command-based program used for paint management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

The provided document is a 510(k) summary for the Siemens SOMATOM Project P45, a computed tomography (CT) system. The document focuses on establishing substantial equivalence to predicate devices and outlines general safety and effectiveness concerns.

Crucially, this document does NOT contain information about specific acceptance criteria or a study that proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or reader improvement with AI.

The information provided describes the device's classification, general indications for use (producing cross-sectional images), and adherence to safety standards and risk management. It confirms FDA clearance based on substantial equivalence to existing CT systems.

Therefore, I cannot extract the requested information from the provided text. To answer your questions, I would need a different type of document, such as a clinical study report, a performance validation study, or a more detailed technical specification.

Here's a breakdown of why each requested point cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on substantial equivalence to predicate devices for its classification as a CT system, not on specific performance metrics.
2. Sample size used for the test set and the data provenance: Not present. No specific test set for performance evaluation is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No performance study is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present. No performance study 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: Not present. This device is a CT scanner, not an AI-assisted diagnostic tool. An AI component is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This device is a CT scanner, not an algorithm, and no standalone performance testing for diagnostic capabilities is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present. No performance study is described.
8. The sample size for the training set: Not present. This device is a CT scanner, not an AI model requiring a training set in the conventional sense.
9. How the ground truth for the training set was established: Not present. This device is a CT scanner, not an AI model, and no training set is relevant in this context.

In summary, the provided 510(k) document for the SOMATOM Project P45 focuses on regulatory clearance for a general-purpose CT system based on substantial equivalence, and does not contain the detailed performance study information you are seeking.

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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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