(55 days)
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.
§ 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.