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uCT 780 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac and vascular).

uCT 780 is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.

• 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.

uWS-CT-Dual Energy Analysis is a post-processing software package that accepts UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information.

The Computed Tomography X-ray system, uCT 780, is intended to produce cross-sectional images of the patient by computer reconstruction of X-ray transmission data taken at different angles and planes. These images may be obtained either with or without contrast.

This 510(k) is to request modifications for the cleared Computed Tomography X-ray system uCT 780. uCT 780 has been previously cleared by FDA via K241079.The modification performed on the uCT 780 (K241079) in this submission is due to the addition of a new high voltage generator. At the same time, we introduce a mobile configuration which supports installation in vehicles. A summary of the modified hardware is provided below:

• A new model of high voltage generator uXG 100 has been introduced in the mobile configuration, and the predicate model CT140N80X4889 is still used in other non-mobile configurations.
• A tilt lock has been introduced to the gantry and a horizontal movement lock has been introduced to the standard config patient table, and the system software has been updated to include the relevant controls and prompts.
• PSC has been modified, including adding a shock-absorbing base, strengthening the sheet metal structure, and optimizing the fixing method of PSC.

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CT VScore+ is a software application intended for non-invasive evaluation of calcified lesions of the coronary arteries based on ECG-gated, non-contrast cardiac CT images for patients aged 30 years or older. The device automatically generates calcium scores for the coronary arteries (combined LM+LAD, RCA, LCX) and highlights the segmented calcium on the original CT image. The device also offers the option for the user to display the calcium scores in the context of reference data from the MESA and Hoff-Kondos databases.

The segmented arteries include combined LM+LAD, RCA, and LCX. To obtain separate LM and LAD results, the user must perform manual segmentation. The segmentation map of calcifications is intended for informational use only and is not intended for detection or diagnostic purposes. The 3D Calcium View output is provided strictly as an informational and supplementary output and should never be used alone as the method of reviewing the calcium segmentation.

CT VScore+ is a software application intended for non-invasive evaluation of calcified lesions of the coronary arteries based on ECG-gated, non-contrast cardiac CT images for patients aged 30 years or older. The application runs on the Vitrea platform.

The device automatically generates Agatston and volume calcium scores for each of the coronary arteries (combined LM+LAD, RCA, LCX) based on the volume and density of the calcium deposits and highlights the Segmented calcium on the original CT image. The device also offers the option for the user to display the calcium scores in the context of reference data from the MESA and Hoff-Kondos databases.

The software uses deep learning-based segmentation methods. Users can edit the automated segmentation, including manually assigning calcifications to anatomical structures.

The device automatically outputs a combined LM+LAD score as the final automated output. To obtain separate LM and LAD results, the user must perform manual segmentation using the provided editing tools.

The device is Software as a Medical Device (SaMD) that operates on ECG-gated, non-contrast cardiac CT DICOM images.

The device does not interact directly with the patient. The device is a software application that runs on the Vitrea platform and processes ECG-gated non-contrast cardiac CT DICOM images. The device automatically generates Agatston and volume calcium scores for each of the coronary arteries (LAD+LM, RCA, LCX) based on the volume and density of the calcium deposits and highlights the segmented calcium on the original CT image. Results can be exported to image management, archival, or reporting systems that support DICOM standards for further review and interpretation.

Results can also be saved in DICOM Structured Reports (DICOM SR) format.

The CT VScore+ device is a software application for non-invasive evaluation of calcified lesions of the coronary arteries from ECG-gated, non-contrast cardiac CT images. The study presented demonstrates the analytical validity and performance of the device against predefined acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): 236 independent cases.
• Data Provenance: The pivotal validation dataset was sourced from diverse U.S. sites and scanner vendors. The development dataset, from which the test set was independent, included data from four institutions (two US sites and two Japanese sites). The 236 cases for validation were "independent" at both the patient level and the site level from the development dataset. It is retrospective data.

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

• Number of Experts: Three.
• Qualifications of Experts: U.S. board-certified radiologists/cardiologists. (Specific years of experience are not mentioned).

4. Adjudication Method for the Test Set

• Adjudication Method: A "2+1 consensus process" was used. This typically means that if two experts agree, their consensus defines the ground truth. If there's a disagreement between two, the third expert acts as a tie-breaker or adjudicator.

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

• The provided document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study to assess the effect size of human readers improving with AI vs. without AI assistance. The study focuses on the standalone performance of the AI algorithm against a consensus ground truth.

6. Standalone Performance Study (Algorithm Only)

• Yes, a standalone performance study was conducted. The metrics listed in the table (ICC, Kappa, Dice Score) directly assess the performance of the CT VScore+ algorithm in isolation against the established ground truth.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus. Specifically, the reference standard ground truth was established by consensus manual scoring on an FDA-cleared device (Vitrea CT VScore, K243240) and a 2+1 consensus process by three U.S. board-certified radiologists/cardiologists.

8. Sample Size for the Training Set

• Sample Size (Training Set): 94 cases (part of the 210 cases used for development).

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

• The document implies that the ground truth for the training set (part of the development dataset) was established similarly to the validation set's ground truth, i.e., "by consensus manual scoring on an FDA-cleared device (Vitrea CT VScore, K243240)" by experts, given that the development process involved ensuring "robust and unbiased performance." However, the exact details of ground truth establishment specifically for the training set are not explicitly broken out as they are for the pivotal validation dataset. It's reasonable to infer a similar rigorous process if the data was used for deep learning model development.

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syngo.CT Dual Energy is designed to operate with CT images based on two different X-ray spectra.

The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Dual Energy combines images acquired with low and high energy spectra to visualize this information. Depending on the region of interest, contrast agents may be used.

The general functionality of the syngo.CT Dual Energy application is as follows:

• Bone Marrow ²⁾
• Bone Removal ¹⁾
• Brain Hemorrhage ¹⁾
• Gout Evaluation ¹⁾
• Hard Plaques ¹⁾
• Heart PBV
• Kidney Stones ¹⁾ ²⁾ ³⁾
• Liver VNC ¹⁾
• Lung Mono ¹⁾
• Lung Perfusion ¹⁾
• Lung Vessels ¹⁾
• Monoenergetic ¹⁾ ²⁾
• Monoenergetic Plus ¹⁾ ²⁾
• Optimum Contrast ¹⁾ ²⁾
• Rho/Z ¹⁾ ²⁾
• SPP (Spectral Post-Processing Format) ¹⁾ ²⁾
• SPR (Stopping Power Ratio) ¹⁾ ²⁾
• Virtual Non-Calcium (VNCa) ¹⁾ ²⁾
• Virtual Unenhanced ¹⁾

The availability of each feature depends on the Dual Energy scan mode.

¹⁾ This functionality supports data from Siemens Healthineers Photon-Counting CT scanners acquired in QuantumPlus modes.

²⁾ This functionality supports data from Siemens Healthineers Photon-Counting CT scanners acquired in QuantumPeak modes.

³⁾ 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 upon consideration of all available information. The accuracy of identification is decreased in obese patients.

Dual energy offers functions for qualitative and quantitative post-processing evaluations. syngo.CT Dual Energy is a post-processing application consisting of several post-processing application classes that can be used to improve the visualization of the chemical composition of various energy dependent materials in the human body when compared to single energy CT. Depending on the organ of interest, the user can select and modify different application classes or parameters and algorithms.

Different body regions require specific tools that allow the correct evaluation of data sets. syngo.CT Dual Energy provides a range of application classes that meet the requirements of each evaluation type. The different application classes for the subject device can be combined into one workflow.

The product is intended to be used for at least 21-year-old humans.

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