(124 days)
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.
| Acceptance Criterion (Inferred from 510(k) Process) | Reported Device Performance (Summary of Functionality) |
|---|---|
| Device functions as intended for specified applications | Combined CT images from two kV levels to visualize and analyze anatomical and pathological structures. |
| Safe and effective for its intended use | Device labeling contains instructions for use, cautions, and warnings. Risk management (hazard analysis) and software V&V are implemented. Adheres to recognized industry practice and standards. |
| Substantially equivalent to predicate devices | Demonstrated equivalence to syngo Dual Energy (K073003), syngo Oncology (K071310), and SOMATOM DR I (K837107). |
| Enables analysis for specific clinical applications | Supported applications include: Lung Nodules, Xenon (Lung Ventilation), Monoenergetic, Brain Hemorrhage, Gout Evaluation, Lung Vessels, Heart PBV, Dual Energy Bone Removal, Cartilage/Tendon/Ligament, Lung Perfusion, Liver, Hard Plaques in Vessels, Kidney Stones. |
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.