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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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The Siemens SOMATOM Perspective system 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 angles or spiral planes* taken at different angles.

In addition the SOMATOM Perspective is able to produce additional image planes and analysis results by executing optional post-processing features, which operate on DICOM images.

For cardiac imaging, which is an option on the system, a new reconstruction algorithm (iTRIM - Iterative 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.

The images and results delivered by the SOMATOM Perspective can be used by a trained physician as an aid in diagnosis. (*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

The Siemens SOMATOM Perspective is a Computed Tomography X- ray System which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The new version of system software, SOMARIS/5 VC30 supports 1) Localized language support of scan protocols. 2) Easy UI Improvement, 3) iMAR, 4) Study Split Improvement, 5) FAST kV, 6) e-Sleep Improvement, 7) syngo. via client, 8) Touch Panel(FAST Positioning), 9) online help based on knowledge gateway, 10) FAST Wizard, 11) new software field update concept. 12) Temporal-MIP. 13) TrueD-4D viewer, 14) Adaptive Signal Boost Improvement, 15) FAST 3D Align, 16) Dual Spiral Dual Energy, 17) FAST DE Results (for Mono-energetic), 18) Tube Protection, 19) Modified Patient Table.

The provided text describes a 510(k) premarket notification for a Computed Tomography X-ray System, the Siemens SOMATOM Perspective, and its updated software version. However, it does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and the study proving the device meets them.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance with specific metrics.
• Sample sizes used for a test set, its data provenance, or the number/qualifications of experts for ground truth establishment.
• Adjudication methods.
• Details of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Details of a standalone algorithm performance study.
• Sample size for the training set or how ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing and adherence to recognized standards.

Here's a summary of the information that is available in the provided text, categorized by your request:

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

• The document states: "Performance tests were conducted to test the functionality of the SOMATOM Perspective configured with software version SOMARIS/5 VC30 syngo® CT VC30-easylQ version. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended."
• It also mentions: "The testing results supports that all the software specifications have met the acceptance criteria."
• However, specific acceptance criteria (e.g., quantitative metrics for image quality, resolution, noise, dose, or specific diagnostic performance benchmarks) and the corresponding reported values are NOT detailed in this document. The document refers to conformance with various IEC and NEMA standards rather than presenting specific performance data for each criterion.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not specified. The document does not describe a clinical test set or its characteristics. The testing mentioned appears to be primarily non-clinical, focusing on engineering verification and validation against standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not specified. As no clinical test set for diagnostic performance is detailed, there's no mention of experts establishing ground truth for such a set.

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

• Not applicable/Not specified. No clinical test set or adjudication method 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, an MRMC study is not mentioned. This document is for a CT scanner and its software updates, not an AI-assisted diagnostic tool in the sense of comparing human reader performance with and without AI. It mentions "iTRIM - Iterative Temporal Resolution Improvement Method" for cardiac imaging, which is a reconstruction algorithm, but its impact is noted as "improves the temporal resolution" rather than a comparative effectiveness study with human readers.

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

• The document implies standalone testing of the software's functionality and adherence to standards: "Performance tests were conducted to test the functionality of the SOMATOM Perspective configured with software version SOMARIS/5 VC30 syngo® CT VC30-easylQ version. These tests have been performed to test the ability of the included features of the subject device." However, concrete performance metrics for such standalone tests are not provided beyond the statement that acceptance criteria were met.

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

• Not specified for a clinical diagnostic context. The "ground truth" implicitly refers to compliance with established engineering and medical device standards (e.g., IEC, NEMA for safety, performance, and software life cycle).

8. The sample size for the training set

• Not applicable/Not specified. This document does not describe a machine learning model that would require a distinct training set in the typical sense of AI development. It refers to software updates and a reconstruction algorithm (iTRIM), but details on their development or "training" are not provided.

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

• Not applicable/Not specified. See point 8.

In summary: This 510(k) submission primarily focuses on demonstrating that the updated SOMATOM Perspective CT system and its software (syngo® CT VC30-easyIQ version) are substantially equivalent to previously cleared predicate devices. The "study" referenced is a series of non-clinical verification and validation tests against established medical device standards and internal specifications, confirming that the device performs as intended and meets its software specifications. It does not provide the kind of detailed clinical performance study data (e.g., sensitivity, specificity, reader studies) that would be expected for a diagnostic AI device.

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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. 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.

Siemens SOMATOM Computed Tomography System family scanners are whole body X-ray computed tomography systems which feature a continuously rotating tube-detector system and functions according to the fan beam principle. The SOMATOM Computed Tomography System family scanners vary in configurations from 6 to 192 slices, and are 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 angles or spiral planes taken at different angles. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The systems described in this submission provide pre-defined low dose scan modes similar to the modes used for The National Lung Screening Trial (NLST), and the features as recommend by the study. This allows use of these systems for screening in the same way the CT systems were used for NLST. The computer system delivered with the CT scanner is able to run post processing applications optionally.

The provided text describes Siemens' application for expanded indications for use for their SOMATOM Computed Tomography (CT) System family scanners to include low-dose lung cancer screening in high-risk populations. The submission asserts that the devices are substantially equivalent to previously cleared versions and that the new indication does not constitute a new intended use.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state specific quantitative acceptance criteria for performance metrics for the low-dose lung cancer screening indication. Instead, it states that the devices perform "comparably or better than" older devices which were used in the NLST study. The performance characteristics compared are standard CT image quality metrics.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Non clinical tests (integration and functional) and phantom testing were conducted for the SOMATOM Computed Tomography System family during product development." It further mentions: "The test results demonstrate that the subject devices perform comparably or better than the older devices. Since the older devices have been identified as suitable for lung cancer screening within the NLST, the respective performance of the subject devices can be regarded as suitable for lung cancer screening as well."

• Sample Size for Test Set: Not specified for new testing. The reliance is on comparability to devices used in the NLST study. The NLST study itself included over 53,000 participants.
• Data Provenance: The new testing focuses on non-clinical phantom testing. The clinical basis for the indication relies on existing clinical literature, specifically referencing the National Lung Screening Trial (NLST) which was a prospective, randomized controlled trial conducted in the United States.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The document does not describe the use of human experts to establish ground truth for the non-clinical phantom testing performed for this submission. The "ground truth" for the acceptance of the lung cancer screening application is implicitly tied to the performance characteristics of the devices used in the NLST study and subsequent literature, as defined by professional medical societies.

4. Adjudication Method for the Test Set

Not applicable, as expert adjudication for performance metrics within this submission is not 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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as part of this submission. The devices are CT scanners, not AI-powered diagnostic aids that directly assist human readers. The submission focuses on the performance of the CT system itself for low-dose lung cancer screening.

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

This is not applicable as the device in question is a CT scanner, not an algorithm, and it requires clinical interpretation by a trained physician.

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

The ground truth for the suitability of the CT systems for low-dose lung cancer screening relies on:

• Clinical Literature: Specifically, the results of the National Lung Screening Trial (NLST) which involved clinical outcomes data (lung cancer incidence, mortality).
• Professional Medical Society Definitions: The indications for use explicitly state "As defined by professional medical societies."
• Technical Guidelines: From organizations like the American College of Radiology (ACR) and National Comprehensive Cancer Network (NCCN).

For the non-clinical performance tests conducted for this submission, the ground truth would be based on physical phantom measurements and known parameters of the phantoms.

8. The Sample Size for the Training Set

The document does not describe a training set in the context of an AI/ML algorithm. The devices are CT scanners, and their development and validation involve engineering, physics, and clinical studies (like NLST, which is referenced as foundational for the indication).

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set for an AI/ML algorithm is described.

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The Siemens SOMATOM Perspective system 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 angles or spiral planes* taken at different angles.

In addition the SOMATOM Perspective is able to produce additional image planes and analysis results by executing optional post-processing features, which operate on DICOM images.

For cardiac imaging, which is an option on the system, a new reconstruction algorithm (iTRIM - Iterative 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.

The images and results delivered by the SOMATOM Perspective can be used by a trained physician as an aid in diagnosis.

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

The SOMATOM Perspective 16 and 32 slice configurations are whole body Xray Computed Tomography Systems. The SOMATOM Perspective 16 and 32 slice configurations produce CT images in DICOM format, which can be used by post-processing applications commercially distributed by Siemens and other vendors.

The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The new version of system software, syngo® CT VC28 (SOMARIS/5 VC28) supports several new features which support more economical and energy efficient scanner operation.

The provided text describes a 510(k) submission for the SOMATOM Perspective CT system, which is a medical device. However, it does not include specific acceptance criteria or an explicit study describing the device's performance against such criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety standards. It mentions "verification and validation testing" and that "all the software specifications have met the acceptance criteria," but it does not detail these criteria or the performance metrics.

Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from the given text, nor can I answer questions about sample size for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not present in the provided submission.

The document states:

• Nonclinical Testing: "Non clinical tests (integration and functional) and phantom testing were conducted for the SOMATOM Perspective 16 and 32 slice configurations during product development. The modifications described in this Premarket Notification were supported with verification and validation testing."
• Acceptance Criteria for Software: "The testing results supports that all the software specifications have met the acceptance criteria."

This indicates that testing was performed and acceptance criteria were met, but the specific details of these are not disclosed in this summary.

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The Siemens SOMATOM Perspective system 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 angles or spiral planes* taken at different angles.

In addition the SOMATOM Perspective is able to produce additional image planes and analysis results by executing optional post-processing features, which operate on DICOM images.

For cardiac imaging, which is an option on the system, a new reconstruction algorithm (iTRIM - Iterative 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.

The images and results delivered by the SOMATOM Perspective can be used by a trained physician as an aid in diagnosis.

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

Similar to the predicate device (Siemens SOMATOM Emotion 16 premarket notification K050297, clearance date 03/01/2005), Siemens SOMATOM Perspective is a Computed Tomography X- ray System, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

The SOMATOM Perspective system produces CT images in DICOM format, which can be used by post processing applications commercially distributed by Siemens and other vendors.

SOMATOM Perspective operates with software version SOMARIS/5 which is a Windows XP®1 based program used for patient management, data management. X-ray scan control, image reconstruction, and image archive/evaluation.

The key software new features for SOMATOM Perspective are iTRIM (Iterative Temporal Resolution Improvement Method) to improve the temporal resolution to a value of about 80% of that of conventionally reconstructed images, and ECO Mode (eMode) to increase the tube life by reducing the tube power.

The computer system delivered with the CT scanner is able to run such post processing applications optionally.

The provided document is a 510(k) summary for the Siemens SOMATOM Perspective CT system. It does not contain acceptance criteria for device performance or the details of a study demonstrating that the device meets such criteria in terms of clinical output or diagnostic accuracy.

The summary focuses on demonstrating substantial equivalence to a predicate device (Siemens SOMATOM Emotion 16) based on technical characteristics and intended use. The "Nonclinical Testing" section mentions verification and validation testing, as well as phantom testing, but it does not provide specific acceptance criteria or detailed results from these tests in relation to clinical performance or diagnostic outcomes.

Therefore, for almost all of the requested information, the answer will be "Not provided in the document."

Here's a breakdown based on the information provided:

Acceptance Criteria and Device Performance Study for SOMATOM Perspective

The 510(k) summary provided does not detail specific acceptance criteria related to clinical performance (e.g., diagnostic accuracy, sensitivity, specificity) for the SOMATOM Perspective, nor does it present a study demonstrating the device meets such criteria for clinical or diagnostic endpoints.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and functionality, particularly for the new features like iTRIM and eMode. It mentions that "The testing results supports that all the software specifications have met the acceptance criteria," but these "software specifications" are not defined in terms of clinical outcomes or performance metrics in a way that would answer the specific questions below.

The "Nonclinical Testing" section refers to phantom testing and verification/validation, which are typical for medical device submissions, but no specific performance statistics are presented.

Therefore, the following information is largely not available from this document:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided. The document states that "all the software specifications have met the acceptance criteria" but does not define these criteria or report specific performance metrics (like diagnostic accuracy, sensitivity, etc.) relevant to a clinical study.

2. Sample Size Used for the Test Set and Data Provenance: Not provided. The document mentions "nonclinical tests" including "phantom testing" but does not describe a test set based on patient data, its size, or provenance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts: Not provided. Since a clinical test set with ground truth is not described, this information is not applicable here.

4. Adjudication Method for the Test Set: Not provided. As no clinical test set for diagnostic performance is described, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC comparative effectiveness study is mentioned in the provided text. The document refers to the iTRIM algorithm improving temporal resolution, stating that "Actual results obtained with iTRIM can vary depending on the particular clinical situation," but it doesn't quantify this improvement in terms of human reader performance or diagnostic effectiveness compared to a standard method.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study: No standalone diagnostic performance study (e.g., sensitivity, specificity, AUC) for the algorithm itself is presented. The document states that the images and results "can be used by a trained physician as an aid in diagnosis," implying human-in-the-loop operation, but no performance metrics for such use are provided.

7. Type of Ground Truth Used: Not provided. Since no clinical performance study is detailed, the type of ground truth is not mentioned.

8. Sample Size for the Training Set: Not provided. The document does not describe the development or training of an AI model with a training set.

9. How the Ground Truth for the Training Set was Established: Not provided. As no training set is described, this information is not applicable.

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