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syngo® Dual Energy is designed to operate with Siemens Dual Source CT scanners. CT images taken at the same time, using two different kV levels, of the same anatomical region of a patient are used. Depending on the region of interest, contrast agents may be used. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. The images are combined to visualize and analyze information about anatomical and pathological structures.

The functionality of the syngo® Dual Energy applications are as follows:

• Lung Nodules
• Xenon (Lung Ventilation)
• Monoenergetic
• Brain Haemorrhage
• Gout Evaluation
• Lung Vessels
• Heart PBV
• Dual Energy Bone Removal
• Cartilage, Tendon, Ligament
• Lung Perfusion
• Liver
• Hard Plaques in Vessels
• Kidney Stones

Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid and non-uric acid stones. For full identification of the kidney stone additional clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis under consideration of all available information. The accuracy of identification is decreased in obese patients.

syngo® Dual Energy Software Package is a post processing application package consisting of the following applications that can be used to improve visualization of various energy dependent materials in the human body:

• . Lung Nodules
• Lung Nodules
  Xenon (Lung Ventilation) .
• Monoenergetic .
• Brain Haemorrhage .
• Gout Evaluation .
• Luna Vessels .
• Heart PBV .
• . Dual Energy Bone Removal
• Cartilage, Tendon, Ligament .
• Lung Perfusion .
• Liver ●
• Hard Plaques in Vessels .
• Kidney Stones .

The output of the syngo® Dual Energy Software Package applications are shown within three orthogonal slices (sagittal, coronal, and axial) as overlay to anatomical grayscale information. Typically the anatomical information is built from a combination of the original dual energy scans (for example 80kV and 140kV or 100 kV and 140kV and/or by using different filters).

Window values, color look-up tables (LUTs) and masking operations for both datasets (anatomical and the material decomposition information) can be interactively defined and user modified. An additional side-by-side display of Dual Energy results is also supported, and navigation and rotation of datasets are provided.

After two series of dual energy images have been loaded from the patient browser (80kV and 140kV or 100 kV and 140kV), three orthogonal slices (sagittal, coronal, and axial) of both spectra are shown within the respective segments on the monitor in grayscale mode. The middle axial, sagittal and coronal view is used for the initial display.

The Kidney Stones application class is a post processing application that uses dual energy information to visualize the chemical composition in kidney stones. The basis for this approach is a material decomposition into tissue, uric acid, and oxalate stones. The result of material decomposition is shown as a color overlay to anatomical gray scale information.

Here's a breakdown of the acceptance criteria and the study details for the syngo® Dual Energy Software Package, specifically concerning the Kidney Stones application class, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the syngo® Dual Energy Software Package as a post-processing application for CT images, with a specific application for Kidney Stones designed to visualize the chemical composition and differentiate between uric acid and non-uric acid stones.

Acceptance Criteria:

The document states that "The testing results supports that all the software specifications have met the acceptance criteria." However, it does not explicitly list quantitative acceptance criteria for the Kidney Stones application's performance (e.g., specific accuracy, sensitivity, or specificity thresholds). Instead, it describes the type of testing performed and the expected outcomes of the software.

Reported Device Performance:

No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity) for the Kidney Stones application are reported in the provided text. The document focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed performance data for the subject device.

Table of Acceptance Criteria and Reported Device Performance:

Study Details

The provided text describes non-clinical testing for the Kidney Stones application class during product development.

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

   • Sample Size: Not explicitly stated as a number of phantoms or stones. It mentions "kidney stones of various chemical composition and sizes" were used.
   • Data Provenance: Retrospective or Prospective is not specified. The data was generated through "Phantom based test" which were "conducted during product development." This implies a controlled, likely prospective, experimental setup using phantoms. No country of origin for data generation is specified beyond the general manufacturing site in Germany for Siemens AG Medical Solutions.

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

   • Not applicable for this phantom-based test. The ground truth was inherent in the known chemical composition and size of the kidney stones placed in the phantoms.

3. Adjudication method for the test set:

   • Not applicable. Ground truth was established by the known composition of the phantom stones, not by expert adjudication.

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 MRMC study was mentioned. The study described is a non-clinical, phantom-based validation of the software's ability to classify stone composition. It does not involve human readers or assess improvement with AI assistance.

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

   • Yes, the described "Phantom based test" appears to be a standalone test of the algorithm's performance in classifying stone composition given known samples. "Classification performance was measured as a function of CTDIval."

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

   • Known chemical composition and size of kidney stones within phantoms. This is a highly controlled, synthetic ground truth, not derived from clinical expert consensus, pathology, or outcomes data from patients.

7. The sample size for the training set:

   • Not specified. The document only covers validation testing, not the specifics of the training data.

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

   • Not specified. The document does not describe the training process or the ground truth establishment for any training data.

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Syngo Dual Energy is designed to operate with Siemens Dual Source CT scanners. CT images taken at the same time, using two different kV levels, of the same anatomical region of a patient are used. Depending on the region of interest, contrast agents may be used. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. The images are combined to visualize and analyze information about anatomical and pathological structures.

The functionality of the syngo® Dual Energy applications are as follows:

• Lung Nodules
• Xenon (Lung Ventilation)
• Monoenergetic
• Brain Haemorrhage
• Gout Evaluation
• Lung Vessels
• Heart PBV
• Dual Energy Bone Removal
• Cartilage, Tendon, Ligament
• Lung Perfusion
• Liver
• Hard Plaques in Vessels
• Kidney Stones

Syngo Dual Energy is designed to operate with Siemens Dual Source CT scanners. CT images taken at the same time, using two different kV levels, of the same anatomical region or a pattern a le penting our trist egion of minterest contrast agentis may be useum int differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. The Images are combined to visualize and analyze information about anatomical and pathological structures.

The functionality of the syngo® Dual Energy applications are as follows:

• Lung Nodules .
• Xenon (Lung Ventilation) .
• · Monoenergetic · · · ·
• Brain Haemorrhage ●
• Gout Evaluation .
• . Lung Vessels
• Heart PBV .
• Dual Energv Bone Removal
• Cartilage, Tendon, Ligament
• Lung Perfusion .
• Liver ●
• Hard Plaques in Vessels
• Kidney Stones

Here's an analysis of the provided text regarding the syngo Dual Energy with extended functionality device:

Important Note: The provided document is a 510(k) summary for a medical device. These summaries are primarily focused on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive clinical study reports that detail acceptance criteria and their fulfillment through rigorous testing. Therefore, much of the requested information (especially quantitative details about specific studies, sample sizes, and expert qualifications) is not present in the provided text. The document focuses on regulatory compliance and the device's intended use and features.

Acceptance Criteria and Device Performance (Based on Available Information)

The 510(k) summary does not explicitly list quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy thresholds). Instead, "acceptance" for a 510(k) comes from demonstrating substantial equivalence to predicate devices and ensuring the device is safe and effective for its intended use through standard engineering practices and risk management.

The "reported device performance" in this context refers to the functionality and intended use as described, implying that these functions are performed safely and effectively, as confirmed through internal verification and validation testing, which is a regulatory requirement.

Study Details (Information Not Explicitly Provided in the 510(k) Summary)

The 510(k) summary does not include the type of detailed study information typically found in clinical trial reports or performance validation studies. This document serves as a regulatory submission for substantial equivalence. Therefore, the following points will indicate what is not present and what can be inferred.

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

   • Not provided. The 510(k) summary does not detail specific test sets, their sample sizes, or data provenance for performance validation. This information would typically be part of internal verification and validation documents or clinical studies, which are not included in this public summary.

2. 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 provided. Ground truth establishment, expert numbers, and qualifications are not disclosed in this summary.

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

   • Not provided. Details on adjudication methods for any test data are not mentioned.

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:

   • Not explicitly mentioned as a formal MRMC study for this device's performance. The document describes "syngo Dual Energy with extended functionality" as software operating with CT scanners. It focuses on the capabilities of the software to process dual-energy CT data for various applications. It does not present evidence of a comparative effectiveness study showing human reader improvement with or without this specific AI-like functionality. While the software provides "analysis information," the summary does not quantify an "AI assistance" effect size on human reader performance.

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

   • Not explicitly detailed as a standalone performance study with metrics. The device is described as "designed to operate with Siemens Dual Source CT scanners" and as an aid to "visualize and analyze information." This implies its role is to generate processed images and data for human interpretation rather than making definitive diagnoses in a standalone capacity. Performance validation would likely involve ensuring the accuracy of the processed information it generates.

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

   • Not provided. The type of ground truth used for any internal validation is not specified.

7. The sample size for the training set:

   • Not applicable / Not provided. The term "training set" is typically associated with machine learning or AI models. While "syngo Dual Energy" processes data, the summary does not describe it as an AI model in the modern sense that would require a distinct "training set" for model learning in the same way. It's a software package that applies algorithms to CT data. If any component did involve machine learning (unlikely for a 2009 submission for this type of software), the training set size is not mentioned.

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

   • Not applicable / Not provided. As above, a specific "training set" and its ground truth establishment are not discussed.

Summary of What the Document Provides:

The provided 510(k) summary focuses on demonstrating:

• The device's intended use and functionality (specific applications like Lung Nodules, Gout Evaluation, etc.).
• Its classification and regulatory pathway (Class II medical device, product code JAK).
• Its substantial equivalence to several predicate devices.
• The manufacturer's adherence to basic safety and effectiveness principles (risk management, V&V, industry standards).

It does not contain the detailed performance study results, acceptance criteria, sample sizes, expert qualifications, or ground truth methodologies that would typically be found in a comprehensive clinical validation report. For a 510(k) submission, the emphasis is on showing that the new device is as safe and effective as a legally marketed predecessor, primarily through technical comparison and established risk management, rather than novel clinical performance studies unless significant new indications or technology are introduced.

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Syngo® Dual Energy is designed to operate with Siemens Dual Source CT scanners. CT images taken at the same time, using two different kV levels, of the same anatomical region of a patient are used. Depending on the region of interest, contrast agents may be used. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. The images are combined to visualize and analyze information about anatomical and pathological structures. The functionality of the syngo® Dual Energy has been extended with additional applications.

Syngo® Dual Energy is designed to operate with Siemens Dual Source CT scanners. CT images taken at the same time, using two different kV levels, of the same anatomical region of a patient are used. Depending on the region of interest, contrast agents may be used. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. The images are combined to visualize and analyze information about anatomical and pathological structures. The functionality of the syngo® Dual Energy has been extended with additional applications.

The provided text is a 510(k) summary for a medical device called "syngo® Dual Energy with extended functionality". It contains details about the device's classification, contact information, and intended use. However, it does not contain any information regarding acceptance criteria, study design, or performance metrics.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets them based on the given text.

The document discusses general safety and effectiveness concerns and states that "Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing." However, it does not elaborate on specific acceptance criteria or the results of these verification and validation tests.

The listed predicate devices suggest this is a substantial equivalence submission, which typically focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than performing a full clinical trial with defined acceptance criteria and performance studies for a novel device.

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With the post-processing application syngo® Dual Energy it is possible to obtain additional information about the chemical composition of body materials. CT images taken at the same time with two different kV levels from the same patient and the same anatomical region are used and the differences in the energy dependence of the attenuation coefficients of different materials are exploited. These images will be combined and analyzed to visualize information about anatomical and pathological structures.

Syngo Dual Energy is designed to operate with Siemens Dual Source CT scanners. CT images taken at the same time, using two different kV levels, of the same anatomical region of a patient are used. Depending on the region of interest, contrast agents may be used. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. The images are combined to visualize and analyze information about anatomical and pathological structures.

Dual Energy CT can be used to obtain intensity measurements with two different spectra and thus provides additional information when compared to single energy. The postprocessing application Syngo Dual Energy uses this additional information to improve the visualization of various energy dependent materials in the human body.

This 510(k) summary for Syngo® Dual Energy does not contain enough information to complete the requested table and study details. Minimal information about validation or verification testing is provided. Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission focuses on device description, indications for use, and substantial equivalence, not performance metrics or acceptance criteria.

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

This information is not provided.

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

This information is not provided.

4. Adjudication method

This information is not provided.

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

This information is not provided. The document describes a post-processing application, not specifically an "AI" device as might be understood today. It does not mention any human reader studies.

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

This information is not explicitly provided. The document states that "Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing." This vague statement could imply standalone testing, but no details are given about the nature or results of such testing.

7. The type of ground truth used

This information is not provided.

8. The sample size for the training set

This information is not provided.

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

This information is not provided.

Summary of Available Information:

The document primarily serves as a 510(k) submission for substantial equivalence, focusing on:

• Device Name: Syngo® Dual Energy
• Classification: Accessory to Computed Tomography System, Class II, Product Code 90 JAK
• Indications for Use: To obtain additional information about the chemical composition of body materials by analyzing CT images taken at two different kV levels, to visualize information about anatomical and pathological structures.
• Predicate Devices: Several Siemens products including Leonardo (syngo Fused Vision 3D), InSpace 4D, Body Perfusion, and SOMATOM DR I.
• General Safety and Effectiveness: Stated to be ensured via risk management, hazard analysis, software development, verification, and validation testing, adhering to industry practice and standards. However, no specific results or methods of these tests are detailed.

In conclusion, this regulatory submission focuses on justifying the device's substantial equivalence to existing products rather than providing detailed performance data from a specific study that meets the acceptance criteria directly.

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