(114 days)
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. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.
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.
Scan&GO:
This in-room scan application is a planning and information system designed to perform the necessary functions required for planning and controlling scans of supported SIEMENS CT scanners. It allows users to work in close proximity to the scanner.
The in-room scan application runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using special protocols
Siemens intends to market a new software version, SOMARIS/10 syngo CT VA30 for Siemens SOMATOM X.cite (CT) Scanner System with mobile workflow options.
Single Source CT Sacnner System:
- . SOMATOM X.cite
- Scan&GO Mobile Medical Application (optional mobile workflow component) ●
The subject device SOMATOM X.cite with SOMARIS/10 syngo CT VA30 is a Computed Tomography X-ray System which feature one (single source) continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM X.cite with Software SOMARIS/10 syngo CT VA30 produces CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens Healthcare and other vendors as an aid in diagnosis, treatment preparation and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanner is able to run optional post processing applications.
The Scan&GO mobile workflow is an optional planning and information software designed to perform the necessary functions required for planning and controlling of the SOMATOM X.cite CT scanner. Scan&GO can be operated on a Siemens provided tablet or a commercially available tablet that meets certain minimum technical requirements. It allows users to work in close proximity to the scanner and the patient. Specifically Scan&GO allows control/display of the following software interactions via a wireless tablet that meets certain minimum requirements:
- Selection of patients o
- O Selection of pre-defined protocols
- Scan parameter display O
- Patient table position display and gantry tilt parameter display o
- Tools and instruction message area, O
- o Patient table position planning area
- O Physiological data display
- Patient data display (e.g. date of birth, name) O
- Display of acquired topogram and tomogram images O
- Finalization of exam (close patient) O
- Mobile Organizer, O
- O Patient Instruction Language ("API languages")
- O Interface to support control function for RTP Laser (e.g. LAP Laser)
- Control of moodlight functions o
- predefined workflow associated question/answer dialog o
NOTE: Scan&GO does not support storage of images. Additionally, Scan&GO cannot trigger a scan or radiation release.
The software version for the SOMATOM X.cite, syngo CT VA30 (SOMARIS/10 syngo CT VA30), is a command-based program used for patient management, X-ray scan control, image reconstruction, and image archive/evaluation. The software platform SOMARIS/10 syngo CT VA30 is designed to provide a plugin interface to support the optional Scan&GO mobile workflow as well as integrate potential advanced post processing tasks, tools, or extendable functionalities. Software version syngo CT VA30 (SOMARIS/10 syngo CT VA30) is a new software version based on syngo CT VA20A (SOMARIS/10 syngo CT VA20) which was cleared for the primary predicate devices in K173632), and supports the same plugin interfaces for the optional Scan&GO mobile workflow and integration of post-processing tasks as the predicate devices.
The SOMATOM X.cite will support the following modifications/further developments in comparison to the predicate devices:
- New/Modified Hardware
- . Table S01: Overview of Hardware modifications supported by software SOMARIS/10 syngo CT VA30
- Software version SOMARIS/10 syngo CT VA30
- Table S02: Overview Software modifications of SOMATOM X.cite with syngo CT VA30 ●
The submission show configuration table and comparison table and use the following Terms to describe various technological characteristics in comparison to the predicate device information:
| Term | Definition |
|---|---|
| N/A | The feature is not supported for the subject device |
| New | The feature is newly supported for Siemens CT Scanners and the subject device |
| Modified | This feature is modified from the previously cleared version |
| Unmodified | This feature remains unchanged from the predicate device |
| Enabled | This feature is currently supported by other cleared Siemens CT systems. This feature |
| will be supported for the subject device with software version SOMARIS/10 syngo CT | |
| VA30 and is unmodified from cleared version. |
The provided text describes the acceptance criteria and the study that proves the device meets them for the SOMATOM X.cite CT system and its associated Scan&GO mobile application.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" alongside specific "reported device performance" values in a quantitative format for the entire device. Instead, it describes various tests performed and states that the tests "meet the pre-determined acceptance criteria" and "all of the software specifications have met the acceptance criteria."
However, specific performance aspects are mentioned:
| Acceptance Criterion (Inferred from Testing) | Reported Device Performance (Summary) |
|---|---|
| General | |
| Functionality and Integration | "The general purpose of each tests is to verify and validate the functionality of the subject device modifications." "Testing supports that all software specifications have met the acceptance criteria." |
| Safety and Effectiveness | "The non-clinical data supports the safety of the device and software verification and validation demonstrates that the subject device SOMATOM X.cite should perform as intended in the specified use conditions." "All test performed meet the pre-determined acceptance criteria and demonstrate that Scan&GO is safe and effective for the intended use." |
| Substantial Equivalence | "The data included in this submission demonstrates that the SOMATOM X.cite performs comparably to the predicate devices currently marketed for the same intended use." "Testing and validation is completed. Test results show that the subject device SOMATOM X.cite, is comparable to the predicate devices SOMATOM go.Top (K173632) and SOMATOM Force (K190578) in terms of technological characteristics and safety and effectiveness and therefore are substantially equivalent to the predicate devices." |
| Specific Features (Non-Clinical Bench Tests) | |
| kV and Filter independent CaScore | "The test results show that performance of special kernel variants Artifical120 and eDDensity and mDDensity is similar or improved within the limits of accuracy of the test com-pared to the respective initial release versions." |
| Recon&GO - Spectral Recon | "Deviations between the already cleared image processing algorithms in Inline DE and the new technical realization "Spectral Recon" are extremely small and are not expected to have any impact on the diagnostic performance. Residual deviations are a consequence of rounding differences and slight differences in implementation." |
| TwinSpiral Dual Energy / TwinSpiral DE | "Based on these results it can be stated that the TwinSpiral Dual Energy CT scan mode provides CT-images of diagnostic quality, which are similar to conventional 120kV images in terms of CT-values and image noise at same radiation dose. The mixed images show a slight reduction in the iodine CT-value, but at the same time image noise at same dose is also lower. So in combination the iodine CNR at same radiation dose is comparable between Mixed images and 120kV images." |
| Flex 4D Spiral - Neuro/Body | "Scan ranges with the new Flex4D Spiral feature can be freely selected within the limits mandated by the scan mode and protocol. The scanned volume was found to be in agreement with the planned scan range for a variety of different tested scan modes, scan lengths and scanners... the irradiated range markers displayed by the scanner acquisition software during the planning of the respective F4DS scans were in good agreement with the exposed area on the film." |
| DirectDensity | "The conducted test performed demonstrated the subject device's ability to show relative mass or relative electron density images." |
| HD FoV | "Phantom testing conducted to assess the subject device ability to provide visualization of anatomies outside the standard field of view and that the image quality standards for radiotherapy applications are met." |
| Contrast media protocol | "Selected Factory Contrast Protocols are within the limits as prescribed by the approved labeling of Ultravist®." |
| InjectorCoupling | "Correctness of the contrast injection parameters transferred between the CT device and the supported injection devices has been verified." |
| FAST Integrated Workflow | FAST Isocentering: "Conducted test for the subject device FAST Isocentering demonstrated that there was a lower isocenter deviation for the subject device in comparison to the predicate device." FAST Range: "Conducted test demonstrated that a lower deviation for landmark boundaries for the subject device in comparison to the predicate device." |
| Electrical Safety & EMC | Compliance with standards: 60601-2-44, 60601-1-2, NEMA PS 3.1 - 3.20, NEMA XR-25, NEMA XR-28, ISO 14971, IEC 62304, ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 62366-1, IEC 60825-1, IEC 60601-2-44, IEC 60601-1-3, IEC 60601-1-6, IEC 61223-2-6, IEC 61223-3-5, IEC 60601-2-28, IEC 62563-1. |
| Wireless Coexistence | "Siemens has considered several measures to address wireless coexistence by design... Tested for Co-Channel, Adjacent Channel, RF Interference, and Separation Distance/Location, ensuring wireless communications were actively transmitting in situations where possible interference may exist." "Scan&GO does not support shared medium access to Siemens Wi-Fi network." |
2. Sample Size Used for the Test Set and Data Provenance
The document details various types of testing, but it does not provide specific sample sizes (e.g., number of patients/cases) for the test sets.
-
Test Sets:
- Non-Clinical Testing: Includes "phantom tests" and "bench tests" (Table S07). No specific sample sizes (number of phantoms or tests) are mentioned for these.
- Customer Use Testing:
- Internal Clinical Use Test: "The CT scanner customer environment is simulated in Siemens Test Cabins." Customers with clinical expertise are invited to perform tests. No sample size is provided.
- External Clinical Use Test: "The CT scanner is tested in the environment of the clinic/hospital." Performed with "selected customer before rollout." No sample size is provided.
- NLST (National Lung Screening Trial) Reference: This is cited as supportive data for the lung cancer screening indication, but the device was not tested in this trial. The NLST itself involved over 53,000 subjects.
-
Data Provenance:
- The testing described is primarily prospective system and software verification and validation conducted by Siemens.
- Country of Origin of Data: Not explicitly stated for Siemens' internal testing, but the manufacturing sites are listed as Forchheim, Germany, and Shanghai, China, suggesting the testing would likely occur in association with these locations or corporate R&D facilities.
- The National Lung Screening Trial (NLST) (referenced for lung cancer screening indication) was conducted in the United States and spanned from 2002 to 2010.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- For Siemens Internal/External Clinical Use Tests: The document mentions "customers with clinical expertise" for internal testing and "selected customer" [sic] for external testing. However, it does not specify the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish ground truth for these tests. The nature of these tests appears to be more about workflow and functionality validation rather than diagnostic performance against a definitive ground truth.
- For the NLST (referenced for lung cancer screening): The NLST used a rigorous process for establishing ground truth, typically involving expert radiologists and follow-up pathology for confirmed malignancies. However, this study was performed independently and not specifically to test the SOMATOM X.cite device. The FDA's reference to NLST is for the clinical literature supporting the indication for use, not for the device's performance validation itself.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth within Siemens' own device performance testing. The clinical use tests described seem to focus on user workflow and system integration rather than diagnostic accuracy requiring multi-reader adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size of Human Readers Improve with AI vs. Without AI Assistance
- No, an MRMC comparative effectiveness study was not done or described in this document. The device is a CT scanner, not an AI-assisted diagnostic tool for interpretation.
- The document describes the CT system's ability to generate images for aid in diagnosis, but it does not include a study on how human readers' performance (e.g., diagnostic accuracy, reading time) improves with the SOMATOM X.cite specifically.
- The only reference to an "AI" type feature is "Artificial120" (a kernel for CaScore) and "ADMIRE" (an iterative reconstruction method), but these are features of image processing, not direct AI assistance for human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- The testing described is for a physical medical device (CT scanner) and its associated software, not a standalone algorithm.
- The "non-clinical testing" and "bench tests" evaluate the functional and image quality performance of the CT system's hardware and software components in isolation or simulated environments, which could be considered analogous to "standalone" performance for individual features (e.g., the accuracy of DirectDensity™ or Recon&GO), but not for a diagnostic algorithm in a clinical context.
7. The Type of Ground Truth Used
Based on the descriptions:
- Bench/Phantom Tests: Ground truth is established by physical phantoms with known properties (e.g., known densities, dimensions, material compositions) and comparisons to established measurements or control values.
- Software Verification & Validation: Ground truth is established by software specifications and requirements, and testing verifies that the software functions as designed and meets these predefined criteria.
- Clinical Use Tests: Ground truth appears to be based on successful workflow completion and user feedback rather than a definitive diagnostic truth for patient cases.
- NLST (reference only): For the lung cancer screening claim, the underlying clinical evidence (NLST) established ground truth through longitudinal follow-up and pathology for confirmed lung cancers. This is external literature, not part of the device's direct performance study.
8. The Sample Size for the Training Set
- This document is for a CT scanner system (hardware and software), not specifically for a machine learning or AI model that requires a dedicated "training set."
- Therefore, no information on the sample size for a training set is provided or applicable in the context of this 510(k) submission. Iterative reconstruction methods (like ADMIRE) are often developed using traditional signal processing and physics-based models, and while some may incorporate statistical or adaptive elements, they aren't typically described with "training sets" in the same way as deep learning AI.
9. How the Ground Truth for the Training Set Was Established
- As a "training set" for an AI or machine learning model is not discussed, this question is not applicable based on the provided document.
§ 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.