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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.

The Siemens SOMATOM Drive 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 Drive 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 the post processing applications optionally. syngo CT VA62A (SOMARIS/7 VA62A) is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation available on the SOMATOM Drive CT system.

Here's a breakdown of the acceptance criteria and supporting studies for the SOMATOM Drive, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria in a dedicated table for the SOMATOM Drive (the new device being reviewed). Instead, it focuses on demonstrating that the SOMATOM Drive meets software specifications and performs comparably to predicate devices. The "reported device performance" is largely implicitly stated by concluding that "all of the software specifications have met the acceptance criteria" and "the SOMATOM Drive performs as intended."

However, we can infer some "acceptance criteria" through the lens of what was tested and compared to predicate devices:

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

• Test Set Sample Size: Not explicitly stated for specific non-clinical tests. The document mentions "clinical images were evaluated" for Dual Source Dual Power mode, but the number of images/patients is not provided.
• Data Provenance:
  • Non-clinical/Software Testing: Conducted "during product development." This implies controlled, in-house testing, likely in Germany where the manufacturing site is located (Siemens Healthcare GmbH, Forchheim, Germany).
  • Clinical Images: "Clinical images were evaluated" suggests retrospective or newly acquired images for validation. No specific country of origin is mentioned.
  • National Lung Screening Trial (NLST): A multi-center randomized controlled trial conducted in the United States. The study started in August 2002 and completed in October 2010.

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

• For the device's technical performance (non-clinical tests, software evaluation):
  • No information is provided about expert involvement for establishing ground truth for the test set used in non-clinical or software testing. These typically rely on defined engineering specifications and quantitative measurements.
• For the clinical images evaluated for Dual Source Dual Power mode:
  • No information provided on experts or their qualifications for evaluating these images.
• For the NLST reference:
  • The NLST involved multiple radiologists at participating centers. The interpretation task for CT was to detect lung nodules of 4mm diameter or greater. The expertise of these radiologists would be broad, as it was a large-scale clinical trial. The document doesn't detail their specific years of experience or sub-specialties beyond being "trained physicians" in the general indications.

4. Adjudication Method for the Test Set:

• No specific adjudication method (e.g., 2+1, 3+1) is mentioned for any of the tests conducted for the SOMATOM Drive itself.
• The NLST, as a large clinical trial, would have had its own established protocols for interpretation, consensus, and potentially adjudication to establish ground truth for its primary endpoints, but this is not detailed in the 510(k) summary regarding the device's performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC comparative effectiveness study was done regarding human readers improving with AI vs. without AI assistance.
• The SOMATOM Drive is a CT scanner, not an AI-assisted diagnostic tool. The document focuses on the hardware and reconstruction software performance, not on AI for interpretation.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop):

• Yes, a standalone performance assessment was conducted for the device's capabilities. The document states:
  • "Nonclinical tests, including dosimetry and image performance, were conducted for the SOMATOM Drive during product development."
  • "The test results show that all of the software specifications have met the acceptance criteria."
  • "Non-clinical tests (integration and functional), including phantom test were conducted during the SOMATOM Drive product development."
  • These tests assess the system's output (images, dose measurements) directly against specified criteria, effectively evaluating its "standalone" algorithmic and hardware performance.

7. Type of Ground Truth Used:

• For non-clinical/software performance:
  • Ground truth was based on engineering specifications and phantom measurements. These are objective, quantifiable standards for image quality, dose, and system functionality.
• For clinical images for Dual Source Dual Power mode:
  • Not explicitly defined, but implied to be based on clinical evaluation of the images by unstated evaluators.
• For the NLST reference (supporting the Indication for Use for lung cancer screening):
  • The NLST's ground truth for lung cancer detection and mortality reduction would have been based on pathology results for confirmed cancers and long-term outcomes data (mortality).

8. Sample Size for the Training Set:

• Not applicable / Not provided. The SOMATOM Drive is a CT imaging system. While it uses complex algorithms for image reconstruction (e.g., ADMIRE, iMAR), these are typically engineered using physics-based models and iterative refinement, not "trained" on large datasets in the way modern deep learning AI models are. Therefore, there isn't a "training set" in the context of machine learning. The algorithms are part of the system's core functionality.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As above, the system uses algorithms that are largely model-based and optimized through engineering principles, rather than being trained on a labeled dataset with a "ground truth" in the AI sense.

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The Siemens syngo. CT Myocardial Perfusion software package has been designed to evaluate perfusion of the myocardium.

The software can calculate blood flow, blood volume, and other hemodynamic parameters from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media.

It supports evaluation of regions of interest and the visual inspection of time attenuation curves.

syngo.CT Myocardial Perfusion is post-processing image analysis software that offers the quantitative analysis of dynamic CT data of the myocardium following the injection of contrast media. By providing information about myocardial blood flow and myocardial blood volume, syngo.CT Myocardial Perfusion allows the evaluation of potential perfusion disturbances in the myocardium due to coronary artery disease. This might aid in the assessment of the hemodynamic relevance of coronary stenosis

syngo.CT Myocardial Perfusion provides a fast simultaneous multi-slice calculation of the following perfusion parameter images:

• Myocardial blood flow (MBF) image .
• Myocardial blood volume (MBV) image ●
• Flow Extraction Product (FE) image ●
• Perfused Capillary Blood Volume (PCBV) image ●
• Extravascular Extracellular Volume (EEV) image
• Time to Peak (TTP) image ●
• Time to Start (TTS) image ●
• Tissue Transit Time (TTT) image ●
• Myocardial Blood Flow Corrected (MBFC) image; this parameter . map is a copy of the Myocardial blood flow (MBF) image

This premarket notification (K150713) for syngo.CT Myocardial Perfusion states that it is a post-processing image analysis software that offers quantitative analysis of dynamic CT data of the myocardium following contrast media injection. It calculates myocardial blood flow (MBF), myocardial blood volume (MBV), and other hemodynamic parameters to evaluate perfusion disturbances caused by coronary artery disease.

The device is considered substantially equivalent to the predicate device, syngo® Volume Perfusion CT Body (K092013). The modifications made to the predicate include:

• Separation of the Myocardial Perfusion algorithm into a stand-alone software application.
• Migration to the syngo.via client-server software platform.
• Updated Graphical User Interface (GUI).
• Additional option to store image results as Enhanced CT.
• Parallel display of several time attenuation curves (TAC).
• A modified Indication for Use specific to Myocardial Perfusion.

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that "the test results show that all of the software specifications have met the acceptance criteria." However, it does not provide a quantitative table of specific acceptance criteria values and corresponding device performance metrics. Instead, it relies on general statements about verification and validation testing.

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

The document mentions "verification and validation testing" and "integration and functional tests." However, it does not specify the sample size (number of cases or images) used for these test sets. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It only mentions that the device uses scans from Siemens SOMATOM Definition Flash and SOMATOM Force scanners and was tested with both normal perfusion data (non-shuttle mode) and shuttle mode data.

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

The document does not provide information on the number of experts used to establish ground truth for any test set or their specific qualifications. The regulatory submission primarily focuses on the technical verification and validation of the software itself rather than clinical validation with expert-derived ground truth.

4. Adjudication Method for the Test Set:

No information regarding an adjudication method (such as 2+1 or 3+1) is provided in the document for any test set. The submission focuses on software testing against its specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

The document does not mention any Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size for human readers improving with or without AI assistance. This type of clinical study is not detailed in this 510(k) submission, which primarily focuses on substantial equivalence based on technical and performance characteristics comparison to a predicate device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The document states, "syngo.CT Myocardial Perfusion is post-processing image analysis software that offers the quantitative analysis of dynamic CT data..." and "As syngo.CT Myocardial Perfusion is a post processing application only..." This suggests that the core functionality of generating perfusion maps and parameters is performed by the algorithm in a standalone manner. The "performance tests were conducted to test the functionality of the subject device, syngo.CT Myocardial Perfusion," which would generally refer to testing the algorithm's output against expected results or specifications. However, specific details of a standalone performance study with quantitative metrics are not provided beyond the general statement of "verification and validation testing."

7. The Type of Ground Truth Used:

The document does not explicitly describe the type of ground truth used for any performance evaluation. Given the nature of a 510(k) for post-processing software, the "ground truth" for the verification and validation (V&V) testing would typically refer to:

• Known input-output relationships: Testing if the software accurately calculates parameters based on defined algorithms and synthetic or well-characterized real data where the expected output is known.
• Comparison to predicate device results: Ensuring the new software produces comparable results to the legally marketed predicate device for similar input data.
• Scientific literature/published models: Conformance to established scientific models for perfusion calculation.

No mention of expert consensus, pathology, or outcomes data being used as ground truth is present in the provided text.

8. The Sample Size for the Training Set:

The document does not provide any information regarding a training set sample size. As a post-processing software application, syngo.CT Myocardial Perfusion is described as utilizing deconvolution and Tofts' models for parameter calculation. This implies that the software is based on established mathematical models and algorithms, rather than a machine learning model that would require a distinct "training set" in the conventional sense. The development likely involved algorithmic optimization and software engineering rather than deep learning model training.

9. How the Ground Truth for the Training Set Was Established:

Since the document does not indicate the use of a "training set" for a machine learning model, it also does not describe how ground truth for such a set was established. The software's underlying algorithms (deconvolution, Tofts' model) are likely validated through theoretical correctness and empirical testing against known physical models or data with pre-calculated expected outputs.

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