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SOMATOM Perspective: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis and treatment preparation. However, the images delivered by this system should not be used as an aid in radiation therapy planning. For cardiac imaging, which is an option on the system, a reconstruction algorithm (iTRIM lterative Temporal Resolution Improvement Method) is used. iTRIM improves the temporal resolution of cardiac CT images compared to conventional cardiac CT image reconstruction. Actual results obtained with iTRIM can vary depending on the particular clinical situation. This CT system can be used for low dose lung cancer screening in high risk populations.* *As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

SOMATOM Scope/ Scope Power: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations * *As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

SOMATOM Emotion 16: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis and treatment preparation. However, the images delivered by this system should not be used as an aid in radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations.* *As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

The subject devices SOMATOM CT Scanner Systems with SOMARIS/5 syngo CT VC50 are Computed Tomography X-ray Systems which support continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM CT Scanner Systems with software version SOMARIS/5 syngo CT VC50 produce CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens Healthcare and other vendors as an aid in diagnosis, treatment preparation and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanners is able to run optional post processing applications. The platform software for the SOMATOM CT Scanner Systems, SOMARIS/5 syngo CT VC50, is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

The provided document (K183548) is a 510(k) Summary for Siemens SOMATOM CT Scanner Systems with new software version SOMARIS/5 syngo CT VC50. This submission primarily focuses on software modifications and the substantial equivalence to previously cleared predicate devices.

It is important to note that this document does not contain the detailed acceptance criteria or the specific study results typically found in a clinical trial report or a comprehensive validation study. Instead, it describes the types of testing performed to support substantial equivalence for a software update to an existing CT system.

Therefore, I cannot populate a table of acceptance criteria with reported device performance or describe specific performance metrics from a multi-reader multi-case (MRMC) study or standalone algorithm study, as this information is not present in the provided text. The document refers to "test results show that all of the software specifications have met the acceptance criteria" but does not detail what those criteria or results are.

However, I can extract the available information regarding testing and validation:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide quantitative acceptance criteria (e.g., "sensitivity > 90%") or specific numerical results for device performance (e.g., "sensitivity was 92%"). It states that the tests generally "met the acceptance criteria" or "conformed to standards."

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

The document mentions "phantom tests" and "analysis of phantom images" but does not specify a sample size for these. It does not refer to a test set comprised of patient data from specific countries or indicate whether it was retrospective or prospective. The testing described is primarily non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The described testing is non-clinical (phantom-based, software V&V, electrical safety, EMC, cybersecurity). Ground truth based on expert review of clinical images is not mentioned.

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

Not applicable. This is not a study involving human readers or clinical image interpretation, but rather non-clinical testing of a CT system's software update.

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. This submission is for a software update to a CT system, not an AI-assisted reading device that directly impacts human reader performance in a diagnostic workflow. The "iTRIM" feature is described as improving temporal resolution for cardiac imaging, but not in the context of an MRMC study with human readers.

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

This document describes a CT system and its software, not a standalone algorithm. The device's performance is assessed through non-clinical means (phantom studies, software testing), not by its "standalone" diagnostic performance on clinical images in the way an AI algorithm for disease detection would be.

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

For the non-clinical testing, the "ground truth" would derive from physics principles, established phantom measurements, and engineering specifications used for verification and validation. For instance, for HU accuracy, the "ground truth" would be the known density of materials in a phantom. There is no mention of clinical ground truth (expert consensus, pathology, outcome data) as this is not a study proving clinical diagnostic accuracy.

8. The sample size for the training set

Not applicable. This document describes a software update for a CT system, not an AI/machine learning algorithm that requires a "training set" of data in the common sense.

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

Not applicable, as there is no mention of a training set for an AI/machine learning algorithm.

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