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The Siemens SOMATOM Definition Flash 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.

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

New software version syngo® VA48 (SOMARIS/7 VA48) is a commandbased program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation that will be available on the SOMATOM Definition Flash CT system. syngo® VA48 (SOMARIS/7 VA48) is a further development to the SOMARIS/7 operating software cleared as part of the predicate devices.

syngo® VA48 is scanner platform software that supports the following device features:

1). New system scanner software version SOMARIS/7 VA48 which includes:

-Respiratory - Analysis of Respiratory Rate & Pitch Adjustment -FAST 3D Reconstruction (FAST 3D Align)

-Multiphase reconstruction with extended Field of View

-FAST DE Results (Dual Energy PACS-ready images) -FAST Contact

-Iterative Reconstruction with extended Field of View

-OEM Varian RGSC Online Mode

-Full 4D Lung Scan

-Applications at CT - syngo.via client

• -Temporal MIP (t-MIP)
• -TrueD 4D Viewer
• 2). ADMIRE Iterative Reconstruction (option)
• 3). iMAR Improved Metal Artifact Reduction (option)
• 4). MARIS (Metal Artifact Reduction in Image Space) Option
• 5). HandCARE Quantitative Dose Reduction Option
• 6). CARE Dose4D Dose Reduction Option

There are no modifications to the hardware of the SOMATMOM Definition Flash.

The provided text is a 510(k) premarket notification for the Siemens SOMATOM Definition Flash CT system. It describes the device, its intended use, and its equivalence to previously cleared predicate devices. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and the study that proves the device meets them.

The document states:

• "The test results show that all of the software specifications have met the acceptance criteria. Verification and validation testing of the device was found acceptable to support the claims of substantial equivalence." (Page 6)
• "Performance tests were conducted to test the functionality of the SOMATOM Definition AS Open configured with software version syngo® VA48. 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. The result of all conducted testing was found acceptable to support the claim of substantial equivalence." (Page 7)

While it confirms that tests were conducted and acceptance criteria were met for software specifications and overall functionality, it does not explicitly list the acceptance criteria themselves, nor does it provide detailed study data, sample sizes, ground truth establishment methods, or specific performance metrics (like sensitivity, specificity, or AUC) that you'd expect from a clinical performance study.

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text. The document focuses on regulatory compliance (510(k) pathway for substantial equivalence) rather than a detailed clinical performance study report.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot provide. The document states that acceptance criteria were met for software specifications and device functionality, but it does not specify what those criteria were (e.g., specific quantitative thresholds for image quality, diagnostic accuracy, or dose reduction) or the numerical 'reported device performance' against them.

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

• Cannot provide. The document mentions "non-clinical tests (integration and functional)" and "Performance tests" but does not detail the nature of these tests in terms of patient data (if any), sample sizes, or data provenance. The focus is on software and system functionality testing.

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):

• Cannot provide. The document does not describe any expert-reviewed test sets or ground truth establishment relevant to clinical performance.

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

• Cannot provide. Not applicable as no expert-reviewed test set is detailed.

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:

• Cannot provide. No mention of MRMC studies or AI assistance for human readers. The device is a CT scanner system with new software features, not an AI-assisted diagnostic tool in the sense of improving human reader performance.

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

• Cannot provide. While there were "Performance tests" and "software verification and validation," the document doesn't provide details to assess if these were purely standalone performance evaluations of an algorithm in a clinical context (e.g., detecting specific pathologies). The tests appear to be primarily functional and integration tests for a CT system's software update.

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

• Cannot provide. No information on ground truth for clinical performance.

8. The sample size for the training set:

• Cannot provide. The document describes software updates for a CT system, not an AI/machine learning model that would typically have a "training set."

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

• Cannot provide. See answer to point 8.

In summary: The provided document is a regulatory submission for a CT system upgrade, demonstrating substantial equivalence through non-clinical and functional testing against recognized standards. It does not contain the detailed clinical performance study information you are seeking.

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The Siemens SOMATOM Definition Flash 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 Definition Flash is able to produce additional image planes and analysis results by executing optional post processing features, which operate on DICOM images.

The images and results delivered by the system 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 Definition Flash is a Computed Tomography X- ray System, which features two continuously rotating tube-detector systems and functions according to the fan beam principle. The SOMATOM Definition Flash produces 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, SOMARIS/7 VA44, allows the reconstruction of images with a slice thickness of 0.5mm for SOMATOM Definition Flash systems equipped with Stellar Detector.

The computer system delivered with the CT scanner is able to run the post processing applications optionally. The Stellar Detector will be offered as an optional upgrade to the cleared SOMATOM Definition Flash CT systems.

The provided text describes a 510(k) submission for the SOMATOM Definition Flash CT System, focusing on modifications introduced with software version SOMARIS/7 VA44. The key modification is the ability to reconstruct 0.5mm slices for systems equipped with Stellar Detector and SAFIRE, providing a z-axis resolution of 0.3mm. The submission details non-clinical testing to support these modifications.

However, the provided text does not contain a table of acceptance criteria or reported device performance metrics in the way typically expected for a detailed study report. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical characteristic comparisons and non-clinical testing.

Here's an attempt to answer the questions based on the available information, highlighting what is missing or not explicitly stated:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria or a table of reported device performance values in the context of a clinical study or a formal validation report against specific performance targets (e.g., sensitivity, specificity for a diagnostic task).

Instead, the "acceptance criteria" appear to be implicit in the non-clinical testing performed, which aimed to confirm the technical capabilities of the new software feature (0.5mm slice reconstruction).

Implicit Acceptance Criteria and Reported Performance (from non-clinical testing):

Study Details

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

   • The document describes "phantom tests" to evaluate the 0.5mm slice width.
   • Test Set Sample Size: Not specified. Phantom studies typically involve multiple acquisitions or varying phantom configurations, but the number of "samples" or "cases" is not quantified.
   • Data Provenance: Phantom data (simulated/controlled environment). No human patient data is mentioned for this specific testing.

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

   • Not applicable/Not mentioned. Phantom studies typically do not involve human experts establishing ground truth in the same way clinical studies do. The "ground truth" for phantom measurements is based on the known physical properties and geometry of the phantom and the expected output based on theoretical understanding or established measurement techniques.

3. Adjudication method for the test set:

   • Not applicable. As this was non-clinical phantom testing, no expert adjudication was involved. The measurements are objective physical assessments.

4. 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. The document explicitly states "Nonclinical Testing" and describes phantom tests. There is no mention of an MRMC study or any assessment of human reader performance or AI assistance. This device is a CT scanner, and the modifications are about image reconstruction capabilities, not an AI-assisted diagnostic tool for human readers.

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

   • Yes, to some extent. The non-clinical testing of the software focuses on the performance of the image reconstruction algorithm itself using phantom data (e.g., measuring MTF, spatial resolution). This can be considered a standalone assessment of the algorithm's capability to produce specific image characteristics.

6. The type of ground truth used:

   • For the non-clinical phantom testing, the ground truth is derived from known physical properties and characteristics of the phantoms used (e.g., precisely manufactured structures for resolution assessment) and established measurement methodologies for CT performance.

7. The sample size for the training set:

   • Not applicable/Not mentioned. This submission does not describe an AI model that requires a training set. The software update is for image reconstruction logic and hardware capabilities, not a machine learning algorithm in the typical sense that would necessitate a trained model.

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

   • Not applicable. As no training set for an AI model is mentioned, there's no ground truth establishment for such a set.

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The Siemens SOMATOM Definition Flash (with Stellar Detector) 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 Definition Flash (with Stellar Detector) is able to produce additional image planes and analysis results by executing optional post processing features, which operate on DICOM images.

The images and results delivered by the system 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 Definition Flash (with Stellar Detector) is a Computed Tomography X- ray System, which features two continuously rotating tube-detector systems 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 Definition Flash (with Stellar Detector) produces CT images in DICOM format, which can be used by post-processing applications commercially distributed by Siemens and other vendors.

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

The provided text is a 510(k) summary for the Siemens SOMATOM Definition Flash (with Stellar Detector) Computed Tomography X-ray system. This document focuses on demonstrating substantial equivalence to a predicate device (Siemens SOMATOM FLASH DS, K082220) rather than presenting a study with specific acceptance criteria and detailed performance data of the new device against those criteria in the context of clinical accuracy or diagnostic efficacy.

Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert qualifications, and detailed study methodologies for assessing the device's diagnostic capabilities is not contained within the provided text.

The document discusses the device's technical specifications, intended use, and general safety and effectiveness concerns related to its design and manufacturing practices, which are typically part of a 510(k) submission for demonstrating substantial equivalence for a medical imaging device. It does not include clinical performance studies with specific metrics like sensitivity, specificity, or reader agreement that would typically be associated with answering the questions you've posed.

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