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syngo.CT Applications is a set of software applications for advanced visualization, measurement, and evaluation for specific body regions.

This software package is designed to support the radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice e.g. in the:

• · Evaluation of perfusion of organs and tumors and myocardial tissue perfusion
• · Evaluation of bone structures and detection of bone lesions
• · Evaluation of CT images of the heart
• · Evaluation of the coronary lesions
• · Evaluation of the mandible and maxilla
• · Evaluation of dynamic vessels and extended phase handling
• · Evaluation of the liver and its intrahepatic vessel structures to identify the vascular territories of sub-vessel systems in the liver
• · Evaluation of neurovascular structures
• Evaluation of the lung parenchyma
• · Evaluation of non-enhanced Head CT images
• · Evaluation of vascular lesions

The syngo.CT Applications are syngo based post-processing software applications to be used for viewing and evaluating CT images provided by a CT diagnostic device and enabling structured evaluation of CT images.

The syngo.CT Applications is a combination of thirteen (13) former separately cleared medical devices which are now handled as features / functionalities within syngo.CT Applications. These functionalities are combined unchanged compared to their former cleared descriptions; however, some minor enhancements and improvements are made for the application syngo.CT Pulmo 3D only.

The provided document is a 510(k) summary for syngo.CT Applications, which is a consolidation of thirteen previously cleared medical devices. The document explicitly states that "The testing supports that all software specifications have met the acceptance criteria" and "The result of all testing conducted was found acceptable to support the claim of substantial equivalence." However, it does not explicitly define specific acceptance criteria (e.g., target accuracy, sensitivity, specificity values) for the device's performance or detail the specific studies that prove these criteria are met. Instead, it relies on the premise that the functionalities remain unchanged from the previously cleared predicate devices, with only minor enhancements to one application (syngo.CT Pulmo 3D).

Therefore, based on the provided text, I cannot fill in precise quantitative values for acceptance criteria or specific study results for accuracy, sensitivity, or specificity. The information provided heavily emphasizes software verification and validation, risk analysis, and adherence to consensus standards, rather than detailing a comparative effectiveness study or standalone performance metrics against a defined ground truth.

Here's a breakdown of the available information and what is missing:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size for Test Set: Not specified in the document.
• Data Provenance: Not specified in the document.

3. 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):

• Number of Experts: Not specified in the document.
• Qualifications of Experts: Not specified in the document.

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

• Adjudication Method: Not specified in the document.

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:

• MRMC Study Done: No. The document does not mention any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The submission focuses on the consolidation of existing, cleared applications.
• Effect Size of Improvement: Not applicable, as no MRMC study is reported.

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

• Standalone Study Done: Yes, implicitly. The document states, "The testing supports that all software specifications have met the acceptance criteria," suggesting that the software's performance was verified and validated independent of human interpretation to ensure its functionalities (visualization, measurement, evaluation) behave as intended. However, specific metrics (e.g., accuracy of a measurement tool compared to a gold standard) are not provided. The phrase "algorithm only" might not be fully accurate here given the device is a visualization and evaluation tool for human use, not an autonomous diagnostic AI.

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

• Type of Ground Truth: Not explicitly specified. Given the nature of visualization and evaluation tools, it would likely involve comparisons to known values, measurements, or expert-reviewed datasets, but the document does not detail this.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable/Not specified. The document describes the device as a consolidation of existing, cleared software applications with "minor enhancements and improvements" only to syngo.CT Pulmo 3D. It does not indicate that new machine learning models requiring large training sets were developed for this specific submission; rather, it refers to the performance of existing, cleared applications.

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

• How Ground Truth for Training Set was Established: Not applicable/Not specified, for the same reasons as point 8. The document does not describe a new AI model training process for this submission.

Summary of Device Rationale:

The core of this 510(k) submission is the consolidation of thirteen previously cleared syngo.CT applications into a single "syngo.CT Applications" product. The applicant, Siemens Medical Solutions USA, Inc., states that the functionalities within this combined product are "unchanged compared to their former cleared descriptions" with only "minor enhancements and improvements" in syngo.CT Pulmo 3D (specifically regarding color assignments for lobe borders).

The document asserts that "The performance data demonstrates continued conformance with special controls for medical devices containing software." It also states, "The risk analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence."

This implies that the "acceptance criteria" largely revolve around the continued functional performance and adherence to specifications of the already cleared individual applications, plus verification of the minor changes to syngo.CT Pulmo 3D, and the successful integration into a single software package. However, quantitative performance metrics for the device against specific clinical tasks are not provided in this 510(k) summary document, as the submission focuses on the substantial equivalence of the consolidated product to its predicate devices, rather than presenting new clinical efficacy data.

Ask a specific question about this device

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:
The 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 update software version, SOMARIS/10 syngo CT VA30 (Update) for Siemens SOMATOM Computed Tomography (CT) Scanner Systems with mobile workflow and 3D Camera options.

This update includes support of additional hardware for the go. platform and includes reuse of optional postprocessing applications for Recon&GO for all scanners subject of this submission.

The SOMATOM CT Scanner Systems that support the same software platform update include:

• . SOMATOM go.Up
• . SOMATOM go.Now
• SOMATOM go.Top .
• SOMATOM go.All .
• . SOMATOM ao.Sim
• . SOMATOM go.Open Pro
• SOMATOM X.cite
• Scan&GO Mobile Medical Application (optional mobile workflow component) .

The subject device SOMATOM go. platform and SOMATOM X.cite with SOMARIS/10 syngo CT VA30 (update) are Computed Tomography X-ray Systems which feature one continuously rotating tubedetector system and function according to the fan beam principle. The SOMATOM go. platform and SOMATOM X.cite with software SOMARIS/10 syngo CT VA30 (update) produces CT images in DICOM format. These images can be used by trained staff for post-processing applications commercially distributed by Siemens Healthcare and other vendors. These images 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 and SOMATOM go. platform CT scanners. Scan&GO can be operated on a Siemens provided tablet or personal computer that meets certain minimum technical requirements. It allows users to work in close proximity to the scanner and the patient.

The software version for the SQMATOM go, platform and SOMATOM X.cite, syngo CT VA30 (update) (SOMARIS/10 syngo CT VA30 (update)), is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The software platform SOMARIS/10 syngo CT VA30 (update) is designed to support a software plugin interface to reuse a subset of stand-alone, cleared processing software applications.

The Siemens Medical Solutions USA, Inc. K200524 submission describes an update to the SOMATOM X.cite and SOMATOM Go Platform CT Scanners (software version SOMARIS/10 syngo CT VA30). The submission focuses on demonstrating substantial equivalence to previously cleared devices through non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document primarily discusses verification and validation testing, with acceptance criteria tied to the fulfillment of requirements and comparable performance to predicate devices. Specific quantitative acceptance criteria are not explicitly detailed in a separate table format within the provided text, but rather described in the "Testing Performed" column of Table S5-06.

2. Sample Sizes Used for the Test Set and the Data Provenance:

• FAST Integrated Workflow (3D Camera): "Clinical data based software validation" was conducted. The specific number of cases or patients is not quantified in the provided text. Data provenance is not explicitly stated beyond "clinical data based software validation," implying it's likely from a clinical setting, but country of origin or retrospective/prospective nature is not specified.
• Contrast Media Protocol: The evaluation was based on factory protocols and comparison to approved drug labeling. This does not involve a "test set" in the traditional sense of patient data.
• Scan&GO Supported Hardware: "Bench test." The sample size for this is not specified. Data provenance is a bench test, presumably conducted by the manufacturer.
• Wireless Coexistence Testing: No specific sample size (number of wireless devices or test scenarios) is mentioned.
• Customer Use Testing:
  • Internal Clinical Use Test: "The CT scanner customer environment is simulated in Siemens Test Cabins. For such a test, customers with clinical expertise are typically invited to perform tests." The number of "customers with clinical expertise" or individual test cases is not quantified.
  • External Clinical Use Test: "The CT scanner is tested in the environment of the clinic/hospital. Typically we perform these tests with selected customer before rollout of the CT scanner." The number of "selected customer" sites or test cases is not quantified. Data provenance is clinical environments.

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

• For the FAST Integrated Workflow, the ground truth for "isocenter deviation" and "landmark boundaries" was established presumably by comparison to a reference or manual measurements, but the document does not specify the number or qualifications of experts involved in establishing this ground truth.
• For the Contrast Media Protocol, the ground truth is established by the "approved labeling of Ultravist® or Visipaque®." No external experts were involved in establishing new ground truth for this test.
• For Customer Use Testing, "customers with clinical expertise" were invited for internal tests, and "selected customer" (presumably clinical staff) performed external tests. The exact number and specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.

4. Adjudication Method for the Test Set:

The document does not describe any explicit adjudication method (like 2+1 or 3+1) for any of the described tests. Performance for FAST Integrated Workflow appears to be based on direct measurement comparison. For customer use tests, it's implied that feedback from "customers with clinical expertise" determined meeting acceptance criteria, but no formal adjudication process is detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, the document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study to measure the effect size of how much human readers improve with AI vs. without AI assistance. The study focuses on the technical performance of the device's features.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, the testing described appears to be primarily focused on standalone algorithm/device performance for the modifications. For example:

• FAST Isocentering and FAST Range: The measurement of deviation is a direct assessment of the algorithm's accuracy in proposing an isocenter or landmark, independent of a human reader's interpretation improvement.
• Recon&GO features are noted as "post-processing algorithms" or "inline results methods" that appear to be integrated for improved workflow, implying their standalone function in generating these results.
• Software Specifications and Wireless Coexistence testing inherently evaluate the algorithm and system performance without explicit human-in-the-loop assessment as the primary outcome.

7. The Type of Ground Truth Used:

• FAST Integrated Workflow: The ground truth for isocenter deviation and landmark boundaries seems to be based on a reference standard or manual measurements to which the device's output is compared. This is an implicit form of expert consensus or highly accurate measurement.
• Contrast Media Protocol: The ground truth is the approved labeling of Ultravist® or Visipaque®, which serves as a regulatory and clinical standard.
• Scan&GO Supported Hardware: The ground truth is the information shown on tablets, serving as a reference for comparison of the in-room monitor's display.
• Software Specifications: Ground truth is defined by the software requirements/specifications themselves.
• Wireless Coexistence Testing: Ground truth is adherence to technical standards and successful communication parameters.
• Customer Use Testing: Ground truth seems to be based on expert opinion/feedback from "customers with clinical expertise" or "selected customer" in clinical environments, confirming the safety and effectiveness of the intended use.
• National Lung Screening Trial (NLST): This is referenced as supportive data for lung cancer screening indications. The ground truth for this external study (NLST) would have been clinical outcomes data (e.g., biopsy-confirmed cancer, mortality). However, it's important to note this is not the ground truth created for the current device's primary testing but rather cited clinical evidence supporting an indication for use.

8. The Sample Size for the Training Set:

The document does not specify any sample sizes for training sets. The submission describes updates to existing CT scanner systems and software, and the testing focuses on the verification and validation of these updates against predicate devices and defined requirements. This implies the core algorithms were likely developed and trained prior to this specific update.

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

Since no training set is mentioned, the method for establishing its ground truth is not described in this document.

Ask a specific question about this device

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:

The 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.

The subject device SOMATOM go.Platform with SOMARIS/10 syngo CT VA30 are Computed Tomography Xray Systems which feature one continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM go.Platform 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 go.Platform CT scanners. 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 the scanner and the patient.

The provided text describes acceptance criteria and testing for the Siemens SOMATOM go.Platform CT Scanners with software version SOMARIS/10 syngo CT VA30, and the Scan&GO mobile medical application.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document details various non-clinical tests conducted, with statements of the test results meeting the acceptance criteria. However, it does not present a single consolidated table of specific, quantifiable acceptance criteria alongside reported performance values for those criteria. Instead, it offers narrative summaries of the testing and its outcomes, indicating successful verification and validation.

Below is a table constructed from the provided text, outlining the features tested and the reported performance (which is generally stated as "met acceptance criteria" or "similar/improved performance").

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

• Check&GO Testing:

  • Sample size: 500 CT-series from 100 patients.
  • Data provenance: Not explicitly stated, but clinical datasets were used ("clinical datasets from 100 patients"). It's specified as a "bench test," which implies it was likely retrospective from an existing data archive. Country of origin is not mentioned.

• Other Non-Clinical Testing (Phantom, Integration, Functional): The document frequently refers to "phantom images," "test levels," "development activities," and "bench tests." No specific sample sizes for these tests (e.g., number of phantom scans) or data provenance are provided beyond the general descriptions of the tests themselves, which are stated as having been conducted "during product development."

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

• Check&GO Testing:

  • Ground Truth Establishment: The datasets were "manually annotated with a detailed GT contrast-state (None, Low, InhomogeneousLow, Standard, InhomogeneousHigh, High)."
  • Number & Qualifications of Experts: Not specified.

• Other Tests: For other tests, such as those involving image quality or physical measurements (e.g., Flex 4D Spiral, DirectDensity), the ground truth is typically derived from physical measurements, reference standards (e.g., known phantom properties), or established technical specifications, rather than expert consensus on clinical interpretation. The document does not mention the use of experts to establish ground truth for these tests. The indication for the new "Kidney Stones" feature notes: "Only a well-trained radiologist can make the final diagnosis under consideration of all available information," suggesting the involvement of radiologists in the clinical context, but not for ground truth establishment specifically for the device's technical validation.

4. Adjudication method for the test set

• The document does not explicitly describe an adjudication method (like 2+1, 3+1, etc.) for any of the test sets. For the Check&GO test, ground truth was "manually annotated," implying a single process for ground truth establishment rather than a consensus/adjudication method among multiple experts.

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

• No MRMC comparative effectiveness study involving human readers and AI assistance is reported for this device in the provided text. The device itself is a CT scanner system and its associated software, not explicitly an AI-assisted diagnostic tool for interpretation in collaboration with human readers. The Check&GO feature is described as "aiding the user," but no study on human performance improvement is included.

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

• The non-clinical performance testing, particularly phantom studies and specific feature evaluations like "kV and Filter independent CaScore," "Recon&GO - Spectral Recon," "TwinSpiral Dual Energy," "Flex 4D Spiral," "DirectDensity," "HD FoV," and "InjectorCoupling," can be considered standalone algorithm/device performance evaluations. These tests assess the technical output and accuracy of the device and its software features independent of human interpretation or interaction during the measurement process. The Check&GO feature's "Bench Test" also evaluates the algorithm's performance against annotated ground truth.

7. The type of ground truth used

• Check&GO: Expert annotation of "detailed GT contrast-state" (None, Low, InhomogeneousLow, Standard, InhomogeneousHigh, High) for 500 CT series.
• Other Feature Tests (e.g., CaScore, Spectral Recon, Flex 4D Spiral, DirectDensity, HD FoV, TwinSpiral DE): Primarily derived from physical phantom measurements, comparison to established technical specifications, or reference images/algorithms (e.g., comparing to initial release versions or conventional 120kV images).
• National Lung Screening Trial (NLST): Outcomes data from a large clinical trial (N Engl J Med 2011; 365:395-409) is cited to support the "low dose lung cancer screening" indication for use, not for direct ground truth establishment during this device's specific validation, but rather as supportive clinical literature for the screening concept itself.

8. The sample size for the training set

• The document does not specify any training set sizes. The studies described are primarily for verification and validation, not for training machine learning models. The Check&GO feature describes "500 CT-series from 100 patients were used for the testing of the algorithm," but this is explicitly called "testing," not training.

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

• Since no training set details (size or establishment method) are provided, this information is not available in the document.

Ask a specific question about this device

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:

1. New/Modified Hardware

• . Table S01: Overview of Hardware modifications supported by software SOMARIS/10 syngo CT VA30

2. 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:

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:

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.

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