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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 staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.

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.

Siemens intends to market a new software version, SOMARIS/10 syngo CT VB10 for the following SOMATOM Computed Tomography (CT) Scanner Systems:

SOMATOM go. Platform CT scanner systems:

• . SOMATOM go.Up
• . SOMATOM go.Now
• SOMATOM go.All
• SOMATOM go.Top
• . SOMATOM go.Sim
• . SOMATOM go.Open Pro

SOMATOM X. Platform CT scanner systems:

• . SOMATOM X.cite
• . SOMATOM X.ceed

In this submission, the above listed CT scanner systems are jointly referred to as subject devices by "SOMATOM go. Platform" and "SOMATOM X. Platform" CT scanner systems.

The subject devices SOMATOM go. Platform and SOMATOM X. Platform with SOMARIS/10 syngo CT VB10 are Computed Tomography X-ray Systems which feature one continuously rotating tubedetector system and function according to the fan beam principle (single source). The SOMATOM go. Platform and SOMATOM X. Platform with software SOMARIS/10 syngo CT VB10 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.

Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists, or technologists. The user must have the necessary U.S. qualifications in order to diagnose or treat the patient with the use of the images delivered by the system.

The platform software for the SOMATOM go. Platform and SOMATOM X. Platform, SOMARIS/10 synqo CT VB10, is a command-based program used for patient management, data management, Xray scan control, image reconstruction, and image archive/evaluation.

The software platform provides plugin software interfaces that allow for the use of specific commercially available post processing software algorithms in an unmodified form from the cleared stand-alone post processing version.

New software version syngo CT VB10 (SOMARIS/10 syngo CT VB10) is a modified software version based on syngo CT VA40 (SOMARIS/10 syngo CT VA40) which was cleared for the predicate device in K211373.

Software version SOMARIS/10 syngo CT VB10 will be offered ex-factory and as an optional upgrade for the applicable existing SOMATOM go. Platform and SOMATOM X. Platform CT Scanner Systems.

The bundle approach is feasible for this submission since the subject devices have similar technological characteristics, software operating platform, and supported software characteristics. The supporting data are similar, primarily one review division/group will be involved, and the indications for use is the same between the devices. All subject devices will support previously cleared software and hardware features in addition to the applicable modifications as described within this submission. The intended use remains unchanged compared to the predicate devices.

The provided text is a 510(k) summary for a Computed Tomography (CT) system. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through non-clinical testing and comparison of technological characteristics. The document does not contain information about comparative effectiveness studies, multi-reader multi-case (MRMC) studies, or detailed clinical study results with ground truth establishment as one might find for a novel AI/ML-driven diagnostic device.

Therefore, many of the requested items (e.g., sample size for the test set, number of experts, adjudication methods, MRMC study effect size, training set details) are not explicitly mentioned in this type of submission. The focus here is on the CT system itself and its software updates, not on a new AI algorithm for detection or diagnosis where such detailed performance metrics against ground truth would be paramount.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria & Reported Device Performance

The document describes "bench testing" as non-clinical supportive testing for specific features. The acceptance criteria are generally qualitative (e.g., "comparable accuracy," "reduce the number of alignment artefacts," "successfully detect needle-tips") rather than specific numerical thresholds.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for any of the individual feature tests. The tests refer to "phantom tests" and "analysis of phantom images". For "myNeedle Guide," it mentions "a wide variety of scans," but no specific number.
• Data Provenance: The document does not specify the country of origin for the test data (phantoms) or if any retrospective/prospective human data was used. Given the nature of these tests (bench testing on phantoms), human patient data is generally not the primary focus for these types of technical evaluations.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not provided as the testing primarily involves technical and phantom-based evaluations, not clinical reader studies requiring expert ground truth.

4. Adjudication Method for the Test Set

• This information is not applicable/provided as detailed clinical studies with reader adjudication are not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• No, an MRMC comparative effectiveness study is not mentioned in this 510(k) summary. The submission focuses on demonstrating substantial equivalence through technical testing and feature comparison, not on quantifying improvement in human reader performance with or without AI assistance.

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

• For the "myNeedle Guide" feature, the 90.76% detection rate of needle tips might be considered a form of standalone performance for that specific algorithmic component, though it's still being evaluated in the context of aiding a human user. For other features, the tests are primarily system-level or component-level functional checks.

7. The Type of Ground Truth Used

• For the non-clinical tests described, the "ground truth" would be established through phantom specifications and controlled experimental setups with known parameters (e.g., precise needle location in a phantom, known artifact presence/absence in a reconstructed image). This is typical for engineering verification and validation testing for CT systems.
• For the "myNeedle Guide," the "ground truth" for needle tip detection would likely be based on the known, true location of the needle tip within the phantom or experimental setup.

8. The Sample Size for the Training Set

• This information is not provided. The document describes software updates and system features, not the development of a new AI model from a training set. If the "myNeedle Guide" used machine learning, its training set details are not described here.

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

• This information is not provided as no training sets are explicitly described.

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.

Siemens intends to update software version, SOMARIS/10 syngo CT VA40 for Siemens SOMATOM Computed Tomography (CT) Scanner Systems with unmodified mobile workflow options. This update also includes optional hardware for CT guided intervention workflow for the X. platform supporting CT Scanner Systems.

SOMATOM go.Platform is comprised of the following 6 CT scanners and optional mobile workflow:

• . SOMATOM go.Up
• SOMATOM go.Now
• SOMATOM go.Top
• SOMATOM go.All ●
• SOMATOM go.Sim ●
• SOMATOM go.Open Pro
• Scan&GO Software (optional mobile workflow component) ●

SOMATOM X. platform is comprised of the following 2 CT scanners and optional mobile workflow:

• SOMATOM X.cite
• SOMATOM X.ceed (new CT Scanner Model)
• Scan&GO Software (optional mobile workflow component) .

The subject device SOMATOM go. platform and SOMATOM X. platform with SOMARIS/10 syngo CT VA40 are Computed Tomography X-ray Systems which feature one continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM go. platform and SOMATOM X. platform with software SOMARIS/10 syngo CT VA40 produces CT images in DICOM format. These images can be used by trained staff for post-processing applications commercially distributed by Siemens Medical Solutions USA, Inc. 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 workflow of the subject device platform CT scanners. Scan&GO can be operated on a Siemens provided various tablet hardware or personal computer 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 or personal computer with Wi-Fi connection 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
• O Tools and instruction message area,
• Patient table position planning area O
• 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")
• Control function for RTP Laser systems O
• O Control of mood light functions
• 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, syngo CT VA40 (SOMARIS/10 syngo CT VA40), is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

The software platform provides a software plugin interface that allows for the use of specific commercially available post processing software algorithms in an unmodified form from the cleared stand-alone post processing version.

Software version syngo CT VA40 (SOMARIS/10 syngo CT VA40) is an update to software version syngo CT VA30A (SOMARIS/10 syngo CT VA30) which was cleared for the primary predicate devices in K200524 and supports the same plugin interfaces for the optional Scan&GO mobile workflow and integration of post-processing tasks as the predicate devices.

The provided text describes a 510(k) premarket notification for Siemens CT scanner systems (SOMATOM go. Platform and SOMATOM X. Platform) with a software update (SOMARIS/10 syngo CT VA40). The document focuses on demonstrating substantial equivalence to a predicate device (SOMATOM X.cite, K200524) rather than presenting a performance study with detailed acceptance criteria and human reader studies for a diagnostic AI.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, AUC for an AI diagnostic device) and comparative effectiveness studies with human readers is not present in this document. This submission primarily focuses on hardware and software modifications and their impact on safety and technical performance, supported by non-clinical testing and adherence to recognized standards.

However, I can extract information related to the technical acceptance criteria and the non-clinical testing performed to meet them, as implied by the document.

Here's a breakdown of the available information based on your request:

1. Table of acceptance criteria and the reported device performance

The document does not provide a specific table of quantitative clinical acceptance criteria (e.g., specific thresholds for sensitivity, specificity, or AUC) for a diagnostic AI device, nor does it report such performance metrics. This is because the submission is for a CT scanner system with software updates, not a new diagnostic AI algorithm that independently provides a diagnosis.

Instead, the acceptance criteria relate to the technical performance and safety of the CT system and its software. The general statement is: "The test results show that all the software specifications have met the predetermined acceptance criteria."

Here's an inferred table based on the non-clinical testing described:

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

• Sample Size: The document does not specify exact sample sizes (e.g., number of images or patients) for the non-clinical testing. It refers to "phantom tests" and "bench tests." For the lung cancer screening indication, it references the National Lung Screening Trial (NLST), which is a large prospective clinical trial, but the submission itself did not conduct a new clinical trial for this specific device. The NLST is cited as supportive literature for the clinical utility of low-dose CT in lung cancer screening, not data directly generated by this device for its performance.
• Data Provenance:
  • Country of Origin: The non-clinical tests were conducted internally by Siemens, likely at their manufacturing and development sites, which include Germany and China (as per manufacturing site listings).
  • Retrospective or Prospective: The non-clinical tests (phantom and bench testing) are inherently prospective in nature because they are controlled experiments performed during product development and verification. The NLST, referenced for lung cancer screening, was a prospective clinical trial.

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

This information is not applicable and therefore not provided in this document in the context of diagnostic AI acceptance criteria. The tests performed are non-clinical (phantom, bench tests) and mechanical/software verification, not human-in-the-loop diagnostic studies requiring expert ground truth labeling.

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

This information is not applicable as it pertains to establishing ground truth for diagnostic interpretation, which was not the focus of this non-clinical testing.

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

An MRMC study was not conducted for this submission. This is not a submission for a new AI diagnostic algorithm but rather for updates to a CT scanner system and its core operating software. The mention of "Scan&GO Software" refers to a mobile workflow control software, not an AI diagnostic assistant.

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

A standalone performance study for an AI diagnostic algorithm was not done. The "software" being updated is the CT scanner's operating system (SOMARIS/10 syngo CT VA40) and command-based program, along with a mobile workflow control application (Scan&GO). These are not presented as standalone AI tools that provide diagnostic output.

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

For the non-clinical testing described:

• Phantom measurements/simulations: The "ground truth" or reference for these tests would be the known physical properties and configurations of the phantoms, or scientifically established benchmarks for image quality parameters.
• Simulated clinical workflow: For things like "MyNeedle Laser," the "accuracy" is likely judged against pre-defined engineering specifications for precision and workflow efficiency.
• Bench testing: Involves controlled experiments against pre-determined requirements and specifications.
• Reference to NLST: For the lung cancer screening indication for use, the ground truth for the clinical utility of low-dose CT screening itself came from the NLST study, which used clinical outcomes (e.g., reduction in mortality from lung cancer) as its primary endpoint. However, this is for the indication, not performance of this specific device's new features.

8. The sample size for the training set

This document does not refer to a training set in the context of an AI algorithm. The software update is for the CT system's operating and control software, not a machine learning model that requires a training set.

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

This is not applicable as no AI training set is discussed or implied by the nature of the software update described.

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:

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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