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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 VB20 for the following SOMATOM Computed Tomography (CT) Scanner Systems:

a) Single Source CT Scanner systems (SOMATOM go. Platform):

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

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

b) Dual Source CT Scanner system:

• SOMATOM Pro.Pulse

The above listed subject devices with SOMARIS/10 syngo CT VB20 are Computed Tomography X-ray Systems which feature one (Single Source) or two (Dual Source) continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM go. Platform and the SOMATOM Pro.Pulse with software SOMARIS/10 syngo CT VB20 produce CT images in DICOM format, which can be used by trained staff for software applications, e.g. 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 provided FDA 510(k) Clearance Letter for the SOMATOM CT Systems focuses heavily on establishing substantial equivalence to predicate devices through comparisons of technological characteristics, hardware, and software. It generally asserts that the device has met performance criteria through verification and validation testing, but it does not provide a detailed "Acceptance Criteria Table" with specific quantitative metrics and reported device performance. Similarly, it describes the types of studies performed (e.g., bench testing, retrospective blinded rater study), but it lacks the specific details requested regarding sample sizes, data provenance, expert qualifications, and effect sizes that would typically be found in a detailed study report.

Therefore, I will extract and synthesize the information that is available in the document and explicitly state where the requested information is not provided.

Understanding the Device and its Changes

The devices under review are Siemens SOMATOM CT Systems (SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, and SOMATOM Pro.Pulse) with a new software version, SOMARIS/10 syngo CT VB20. This new software version builds upon the previous VB10 version cleared in K233650 and K232206.

The submission focuses on modifications and new features introduced with VB20, including:

• Eco Power Mode: New feature for reduced energy consumption during idle times (not supported on go.Now and go.Up).
• Oncology Exchange: New feature for transferring prescription information from ARIA Oncology Information System.
• myExam Contrast: New feature for exchanging contrast injection parameters.
• FAST 3D Camera/FAST Integrated Workflow: Modifications including retrained algorithms, collision indication, and Centerline/Grid Overlay.
• FAST Planning: Extended to detect additional body regions.
• myExam Companion (myExam Compass/myExam Cockpit): Clinical decision trees now available for child protocols.
• HD FoV 5.0: New extended field of view reconstruction algorithm (for go.Sim and go.Open Pro only).
• CT guided intervention – myAblation Guide interface: New interface.
• Flex 4D Spiral: Modifications regarding dynamic tube current modulation.
• ZeeFree RT: New stack artifact reduced reconstruction for respiratory-related examinations (for go.Open Pro only).
• DirectDensity: Modified to include stopping-power ratio (Kernel St).
• DirectLaser: Patient Marking workflow improvement.
• Respiratory Motion management - Open Online Interface: New interface for respiratory gating.
• DirectSetup Notes: Enabled for certain SOMATOM go. Platform systems.

The core argument for clearance is substantial equivalence to predicate devices. This means that, despite modifications, the device is as safe and effective as a legally marketed device (the predicates).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a specific table of quantitative acceptance criteria with corresponding reported device performance values. Instead, it describes general acceptance criteria related to verification and validation tests and then provides qualitative statements about the test results demonstrating comparability or improvement over predicate devices.

Here's a summary of the described performance evaluations:

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

The document provides very limited, qualitative information:

• FAST 3D Camera: Optimized using "additional data from adults and adolescence patients." No specific number of patients or images mentioned.
• FAST Planning: Evaluated on "patient data." No specific number of patients or images mentioned.
• HD FoV 5.0: Evaluated with "physical and anthropomorphic phantoms."
• Flex 4D Spiral: No specific sample size or data type mentioned for performance assessment.
• ZeeFree RT: Evaluated with "homogeneous water phantom," "phantom with tissue-equivalent inserts," "static torso phantom," and "dynamic thorax phantom." Also, "retrospective blinded rater studies of respiratory 4D CT examinations performed at two institutions." No specific number of phantoms, images per phantom, or patient cases mentioned.
• DirectDensity: Evaluated on "SOMATOM CT scanner models." No specific sample size or data type mentioned.

Data Provenance:

• Country of Origin: Not specified for the patient data used for algorithm optimization/validation.
• Retrospective or Prospective:
  • FAST 3D Camera: Implied retrospective as it uses "additional data."
  • FAST Planning: Implied retrospective as it uses "patient data."
  • HD FoV 5.0: Retrospective for the blinded rater study.
  • ZeeFree RT: Retrospective for the blinded rater study of clinical cases. The phantom tests are by nature not retrospective/prospective.

3. Number of Experts and Qualifications for Ground Truth

• HD FoV 5.0: "board-approved radio-oncologists and medical physicists." The number of experts is not specified.
• ZeeFree RT: "board-approved radio-oncologists and medical physicists." The number of experts is not specified.

For other tests, ground truth appears to be established by phantom measurements or internal engineering verification, rather than human expert reads validating clinical ground truth.

4. Adjudication Method for the Test Set

The document mentions "retrospective blinded rater study" for HD FoV 5.0 and ZeeFree RT. However, it does not specify the adjudication method used (e.g., 2+1, 3+1, none) for these studies. It only states they were "blinded."

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

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned for HD FoV 5.0 and ZeeFree RT. Both were "retrospective blinded rater studies."
• Effect Size: The document does not report specific effect sizes (e.g., how much human readers improve with AI vs. without AI assistance). It only states that the purpose of the comparison was to "demonstrate that the HD FoV 5.0 algorithm is as safe and effective as the HD FoV 4.0 algorithm" and for ZeeFree RT that it "enables the optional reconstruction of stack artefact corrected images, which reduce the strength of misalignment artefacts." This implies an assessment of non-inferiority or improvement in image quality, but specific quantitative results for reader performance are not provided in this excerpt.

6. Standalone (Algorithm Only) Performance

The document describes tests for several algorithms (FAST 3D Camera, FAST Planning, HD FoV 5.0, Flex 4D Spiral, ZeeFree RT, DirectDensity) using phantoms and "patient data." These evaluations seem to be focused on the algorithm's performance in generating images or calculations, independent of human interpretation in some cases (e.g., accuracy of FAST 3D Camera, correctness percentage of FAST Planning).

However, it does not explicitly use the term "standalone performance" to differentiate these from human-in-the-loop assessments. The mention of "retrospective blinded rater studies" for HD FoV 5.0 and ZeeFree RT indicates a human-in-the-loop component for that specific evaluation, but the phantom testing mentioned alongside them would be considered standalone.

7. Type of Ground Truth Used

• Phantom Data: For HD FoV 5.0, Flex 4D Spiral, ZeeFree RT, and DirectDensity, physical and/or anthropomorphic phantoms were used, implying the ground truth is precisely known physical characteristics or pre-defined phantom configurations.
• Expert Consensus/Reads: For HD FoV 5.0 and ZeeFree RT, board-approved radio-oncologists and medical physicists performed retrospective blinded rater studies, implying their interpretations/ratings served as a form of ground truth or evaluation metric. It's not explicitly stated if this was against a clinical gold standard (e.g., pathology) or if it was a comparative assessment of image quality and clinical utility.
• Internal Verification: For FAST 3D Camera, FAST Planning, accuracy was assessed, likely against internal system metrics or pre-defined ideal outcomes.

8. Sample Size for the Training Set

The document does not provide any specific information about the sample size used for training the algorithms (e.g., for FAST 3D Camera, FAST Planning, HD FoV 5.0, ZeeFree RT). It only states that FAST 3D Camera was "optimized using additional data" and FAST Planning's algorithm had "product development, validation, and verification on patient data."

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

The document does not provide any specific information on how the ground truth for the training set was established. It only mentions the data types used for validation/verification (phantoms, patient data from two institutions, expert raters).

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This computed tomography system is intended to generate and process cross-sectional images by computed reconstruction of x-ray transmission data within a 26 cm field-of-view, for the head and neck.

The images delivered by the system can be used by a trained staff as an aid in diagnosis.

The SOMATOM On.site with software version syngo CT VB10 is a mobile computed tomography (CT) scanner system that will be offered in two variants:

• . SOMATOM On.site for Intensive Care Unit (ICU) Mobile CT scanner affixed to a motorized trolley for use in hospital situations. The scanner can be moved from patient bed to patient bed to perform scanning at the point of care. Although it might be used in other environments like emergency rooms or angiography labs, the main location where this scanner will be used, will be the intensive care unit (ICU).
• . SOMATOM On.site for Mobile Stroke Unit (MSU) Mobile CT Scanner that is mounted to the floor of a diagnostic room or vehicle. The system main place where the scanner will be mounted is in a mobile stroke unit (MSU), which is a specific type of ambulance.

The subject device SOMATOM On.site with SOMARIS/10 syngo CT VB10 is a mobile Computed Tomography X-ray Systems which features a continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM On.site with software SOMARIS/10 syngo CT VB10 produces CT images in DICOM format, which can be used by trained staff for postprocessing applications commercially distributed by Siemens Healthcare and other vendors as an aid in diagnosis and treatment preparation. The computer system integrated with the CT scanner is able to run optional post processing applications.

The Siemens SOMATOM On.site (SOMARIS/10 syngo CT VB10) is a computed tomography (CT) X-ray system. The provided text describes the non-clinical testing performed to demonstrate the device's performance and substantial equivalence to predicate devices. The study focuses on evaluating specific upgraded software features (FAST kV, CARE Dose4D, X-CARE, ADMIRE).

Here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document describes phantom-based measurements for the non-clinical testing. Specific numerical sample sizes (e.g., number of scans, number of phantoms) are not explicitly provided beyond mentioning "a cylindrical 20 cm water phantom" and "PTFE object" for ADMIRE. The data provenance is not explicitly stated as retrospective or prospective, but given it's "bench testing" performed "during product development," it implies a prospective non-clinical study design. The "country of origin of the data" is not specified but is likely internal to Siemens Healthineers.

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

For non-clinical phantom studies, the concept of "experts establishing ground truth" as it would apply to clinical image interpretation is not directly applicable. The "ground truth" for these tests is established by:

• Physical properties of the phantoms: The known composition and dimensions of the water and PTFE phantoms.
• Established quantitative image quality metrics: Such as CNR, MTF, and noise measurements, which are objectively calculated by the system or analysis software based on internationally recognized standards.
• Comparison to predicate device performance: For CARE Dose4D and X-CARE, performance is compared to the established and cleared predicate device, SOMATOM go.Up.

Therefore, no external clinical experts are mentioned for establishing ground truth in these specific non-clinical tests.

4. Adjudication Method for the Test Set

Not applicable for non-clinical phantom studies based on objective quantitative measurements. The assessment is based on direct measurement results against pre-defined acceptance criteria.

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

No. The provided text describes non-clinical bench testing using phantoms, not clinical studies involving human readers or cases. Therefore, no MRMC study was performed, and no effect size for human reader improvement with/without AI assistance is reported.

6. Standalone Performance Study

Yes, the studies reported are standalone (algorithm only) performance evaluations of specific software features (FAST kV, CARE Dose4D, X-CARE, ADMIRE) on the SOMATOM On.site CT scanner, using phantoms. This is a non-human-in-the-loop assessment of the technical performance of the algorithms and hardware.

7. Type of Ground Truth Used

The ground truth used is primarily based on:

• Known physical properties of phantoms: e.g., known dimensions, material composition (water, PTFE), and contrast agent concentrations.
• Objective quantitative measurements: Metrics like Contrast-to-Noise Ratio (CNR), Modulation Transfer Function (MTF) for sharpness, and noise levels.
• Performance of a predicate device: For CARE Dose4D and X-CARE, the performance of the predicate device (SOMATOM go.Up) serves as a benchmark for "comparable performance."

8. Sample Size for the Training Set

The document does not specify a separate "training set" or its size. The features being evaluated (FAST kV, CARE Dose4D, X-CARE, ADMIRE) are algorithmic components of the CT system. While these algorithms might have been developed using various data, the document focuses on the validation testing of their performance on the new device, not their initial development or training. It states that ADMIRE was "originally approved with K133646," indicating it's an existing algorithm that has been integrated.

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

As no training set is explicitly mentioned or detailed in this document, the method for establishing its ground truth is also not provided. The focus is on the verification and validation of the integrated system.

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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.

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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 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.

The subject device SOMATOM Pro.Pulse with software version SOMARIS/10 synqo CT VB10 is a Computed Tomography X-ray system which features two continuously rotating tube-detector system (dual source) and functions according to the fan beam principle. The SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 produces CT images in DICOM format. The images delivered by the system 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, radiation therapy planning, and therapeutic interventions (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 platform software for the SOMATOM Pro.Pulse is SOMARIS/10 syngo CT VB10. It 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 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.

The provided text describes the Siemens SOMATOM Pro.Pulse CT system, its modifications, and its substantial equivalence to predicate devices, but it does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. Instead, it refers to broad categories of non-clinical testing and general statements about meeting pre-determined acceptance criteria.

Here's an attempt to structure the answer based on the available information. Many fields will be marked as "Not Provided" due to the nature of the document being a 510(k) summary, which often focuses on establishing substantial equivalence rather than detailed study results for specific performance metrics.

Acceptance Criteria and Device Performance Study for SOMATOM Pro.Pulse

The K232206 submission for the SOMATOM Pro.Pulse focuses on demonstrating substantial equivalence to its predicate devices (SOMATOM go.Top (K211373) and SOMATOM Drive (K230421)). The document details non-clinical testing performed to verify and validate modifications and ensure the device's functionality, image quality, and safety are comparable to the predicates.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria alongside numerical performance results for the device. Instead, it offers qualitative descriptions of performance objectives and outcomes for various features based on bench testing.

2. No introduction of new artifacts by SAC reconstruction.
3. Equivalent image quality (noise, homogeneity, high-contrast resolution, slice thickness, CNR) in phantom-based measurements compared to standard reconstruction.
4. Equivalent image quality with metal objects compared to standard reconstruction.
5. Successful application of SAC algorithm to phantom data, demonstrating correct technical function and independence from physical detector width. | 1. "If misalignment artefacts are identified in non-corrected standard ECG-gated reconstructed sequence or spiral images, the feature "Cardiac Stack Artefact Correction" (SAC, marketing name: ZeeFree) enables optional stack artefact corrected images, which reduce the number of alignment artefacts."
6. "The SAC reconstruction does not introduce new artefacts, which were previously not present in the non-corrected standard reconstruction."
7. "The SAC reconstruction does realize equivalent image quality in quantitative standard physics phantom-based measurements (ACR, Gammex phantom) in terms of noise, homogeneity, high-contrast resolution, slice thickness and CNR compared to a non-corrected standard reconstruction."
8. "The SAC reconstruction does realize equivalent image quality in quantitative and qualitative phantom-based measurements with respect to metal objects compared to a non-corrected standard reconstruction."
9. "The SAC algorithm can be successfully applied to phantom data if derived from a suitable motion phantom demonstrating its correct technical function on the tested device. The SAC algorithm is independent from the physical detector width of the acquired data." |
   | Dual Source Dual Energy (DSDE) | Successful implementation of DSDE with 80 kV / Sn140 kV and 100 kV / Sn140 kV voltage combinations.
   Image quality and spectral properties (iodine ratio) comparable to the reference device (SOMATOM Drive).
   All applied image quality tests passed. | "The measurements show that the spectral characteristics of the system in terms of iodine ratio are well comparable to the reference device SOMATOM Drive. All applied tests concerning image quality passed." |
   | FAST 3D Camera/FAST Integrated Workflow | Accuracy of FAST Isocentering, FAST Range, and FAST Direction comparable to the predicate device with syngo CT VA40 (old camera hardware, ceiling mount). | "The FAST Isocentering accuracy of the subject device with syngo CT VB10 is comparable to the predicate device with syngo CT VA40, regardless of the camera mounting position."
   "For the FAST Range feature, the detection accuracy of all body region boundaries is comparable between the subject device with syngo CT VB10 and predicate device with syngo CT VA40."
   "The FAST Direction pose detection results are of comparable accuracy for subject and predicate device, regardless of the camera mounting position."
   "Overall, the SOMARIS/10 syngo CT VB10 delivers comparable accuracy to the SOMARIS/10 syngo CT VA40 predicate for the new FAST 3D Camera hardware, also in the new gantry position." |
   | myNeedle Guide (with myNeedle Detection) | 1. High accuracy of automatic needle detection algorithm.
10. Reduction of necessary user interactions for navigating to a needle-oriented view. | 1. "It has been shown that the algorithm was able to consistently detect needle-tips over a wide variety of scans in 90.76% of cases."
11. "Further, the results of this bench test clearly shows that the auto needle detection functionality reduces the number of interactions steps needed to generate a needle-aligned view in the CT Intervention SW. Zero user interactions are required and a needle-aligned view is displayed right away after a new scan, if auto needle detection is switched on in the SW configuration." |
    | CARE kV | Effective mAs settings of low and high kV acquisitions in TwinkV scan adapted by CARE kV to maintain image quality (CNR).
    Consistency of image qualities (CNR values) in certain phantoms under different kV settings in "Manual kV" mode.
    Consistency of contrast, noise, and CNR values in mix images for all voltage combinations. | "Using CARE kV for TwinkV, contrast, noise, and CNR values in the mix images are consistent for all voltage combinations. In all cases, CNR values do not deviate by more than 10% from the average CNR over the available voltage combinations." |
    | Flex 4D Spiral - Neuro/Body | No artifacts should be observed due to missing data, indicating correct trajectory functioning, even with pitch setting changes. | "No artifacts had been observed for any F4DS scan mode due to missing data, indicating that the trajectories work properly in hand. This also accounts for the scenario, where the user may change the pitch setting to get access to another range of scan coverages." |
    | Low-Dose Lung Cancer Screening | Technical parameters specific to Low-Dose Lung Cancer Screening comparable to predicate and subject devices. | "It can be concluded that the subject and predicate devices are substantially equivalent for the task of Low-Dose Lung Cancer Screening since the bench test results showed comparable technical parameters." |

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

The document mentions "phantom studies" and "phantom data" for several tests (ZeeFree, Dual Source Dual Energy, CARE kV, Flex 4D Spiral). For FAST 3D Camera, it tested the subject device against the predicate. For myNeedle Guide, it states the algorithm was able to consistently detect needle-tips in "90.76% of cases" over "a wide variety of scans." However,

• Specific sample sizes (N) for phantom studies or "a wide variety of scans" are not provided.
• Data Provenance (e.g., country of origin, retrospective/prospective) is not explicitly stated for these performance tests. Given they are "bench tests" and "phantom studies," they implicitly suggest a controlled laboratory setting (likely at the manufacturing locations in Germany or China) rather than clinical patient data. The reference to the National Lung Screening Trial (NLST) is supportive literature for the additional lung cancer screening Indications for Use, not a test set for the device's technical performance.

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

• Not Provided. The non-clinical tests described in the document appear to be technical performance evaluations, primarily using phantoms and comparing against known technical specifications or established predicate device performance. There is no mention of experts establishing ground truth for these technical tests.

4. Adjudication Method for the Test Set

• Not Provided. This is typically relevant for studies involving human interpretation or clinical outcomes, which are not detailed for the device's technical performance validation.

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

• No, an MRMC comparative effectiveness study is not described for the SOMATOM Pro.Pulse's performance relative to its predicate devices. The document focuses on demonstrating comparable technical performance through non-clinical bench testing.
• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no MRMC study comparing human readers with and without AI assistance is detailed.

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

• Yes, the described "bench tests" and "phantom studies" are effectively standalone algorithm-only performance evaluations. For example, the ZeeFree reconstruction and myNeedle Detection algorithm evaluations are reported based on their intrinsic technical performance in a controlled setting without human intervention in the loop of image acquisition or primary interpretation for the purpose of the validation described.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests appears to be:

• Known phantom properties and measurements: For image quality metrics (noise, homogeneity, resolution, CNR, slice thickness).
• Known mechanical or digital parameters: For features like FAST 3D Camera (accuracy of Isocentering, Range, Direction) and Flex 4D Spiral (absence of artifacts due to missing data).
• Predicate device performance: Used as a reference for comparison, implying its performance is considered a benchmark or "ground truth" for equivalence.
• Quantifiable algorithm outputs: For myNeedle Detection, the algorithm's ability to consistently detect needle tips (90.76% accuracy).

8. The Sample Size for the Training Set

• Not Provided. The document describes bench testing for verification and validation, but it does not specify details about the training data used for any machine learning components (such as the optimization of the FAST 3D Camera algorithms or myNeedle Detection, if they involve machine learning).

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

• Not Provided. Similar to the training set size, the method for establishing ground truth for any potential training data is not detailed in this submission summary.

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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 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.

The subject device SOMATOM CT Scanner Systems with SOMARIS/7 syngo CT VB30 are Computed Tomography X-ray Systems which feature one (single source) continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM CT Scanner Systems with Software SOMARIS/7 syngo CT VB30 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 platform software for the SOMATOM CT Scanner Systems, SOMARIS/7 syngo CT VB30, is a commandbased program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on functional verification and validation testing rather than explicit, quantifiable acceptance criteria with corresponding performance metrics for each feature in a tabular format. Instead, it describes the objective of each test and then states that the results were found to be acceptable or passed.

However, we can extract the objectives and the documented outcomes for features where some quantifiable or descriptive performance is mentioned:

• Median difference between true and personalized delay 90% of patients.
• Higher overall and more uniform attenuation in individualized cohort vs. fixed.
• Higher contrast-to-noise ratio (CNR) and subjective image quality in individualized cohort.
• Able to adjust scan timing to altered protocols to reach diagnostic image quality despite slower injection rate and reduced iodine dose.
• Images with individualized post-trigger delay provided higher attenuation for all organs.
• Mean vessel enhancement significantly higher in individualized scan timing group. |
  | FAST 3D Camera (Adolescent support) | Achieve comparable or more accurate results than predicate for adults, while supporting adolescent patients (120 cm+) with comparable accuracy as adult patients. | Achieves the objective of the test. (Implies comparable or more accurate results). |
  | FAST Isocentering (Adolescent support) | Lateral isocenter accuracy of subject device comparable to predicate for adult patients, and similar accuracy for adolescent patients. | Comparable to predicate for adult patients; similar accuracy for adolescent patients. |
  | FAST Range (Adolescent support) | Robustness of groin landmark improved; other landmarks detected with comparable accuracy for adults; accuracy of landmark detection for adolescents similar to adults. | Robustness of groin landmark improved; other landmarks with comparable accuracy. For adolescents, similar accuracy to adults. |
  | FAST Direction | Comparable accuracy of pose detection to predicate device. | Comparable accuracy. |
  | FAST Planning | Fraction (percentage) of correct ranges that can be applied without change; calculation time meets interactive requirements. | For >90% of ranges, no editing action was necessary to cover standard ranges. For >95%, the speed of the algorithm was sufficient. |
  | Tin Filtration (New kV combinations) | Successful implementation of new voltage combinations (80/Sn140 kV and 100/Sn140 kV) verified; description of spectral properties given; improved CNR in spectral results (monoenergetic images). | Successful implementation verified via phantom scans and image quality criteria evaluation. All applied tests concerning image quality passed. Different spectral properties with and without Sn filter evident, and Sn filter improves spectral separation considerably. Results support claims related to improved CNR. |
  | General Non-Clinical Testing (Integration & Functional) | Verify and validate functionality of modifications. Ensure safe and effective integration. Conformance with special controls for software medical devices. Risk mitigation. | All software specifications met acceptance criteria. Testing supports claims of substantial equivalence. |

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

• FAST Bolus: The test describes using a "real contrast enhancement curve" determined by measurements with a dynamic scan mode. The subsequent supporting peer-reviewed studies provide more detail:

  • Korporaal et al. (2015): Not explicitly stated, but implies a cohort undergoing bolus tracking.
  • Hinzpeter et al. (2019): 108 patients received patient-specific trigger delay (subject), 108 patients received fixed trigger delay (reference). Prospective CT angiography scans of the aorta.
  • Gutjahr et al. (2019): 3 groups, 20, 20, and 40 patients respectively.
  • Yu et al. (2021): 104 patients (52 per group, implied) in abdominal multiphase CT, comparing individualized vs. fixed post-trigger delay.
  • Yuan et al. (2023): 204 consecutive participants randomly divided into two groups (102 patients each). A prospective study in coronary CT angiography (CCTA).
  • Schwartz et al. (2018): Not explicitly stated, but implied patient-specific data.
  • Data Provenance: The supporting studies imply a mix of retrospective analysis (e.g., Korporaal et al. simulating retrospectively differences) and prospective studies based on the descriptions provided. The locations of these studies are not explicitly mentioned in the excerpt, but given Siemens' global presence, it's likely multi-national.

• FAST 3D Camera, FAST Isocentering, FAST Range, FAST Direction, FAST Planning, Tin Filtration: For these features, the testing is described as "bench testing" using phantoms and internal validation. "Patient data" is mentioned for FAST Planning but without specific numbers.

  • Sample Size: Not specified for these internal bench tests; often involves phantom studies rather than patient-level data for performance metrics. For FAST Planning, it refers to "patient data" for validation, but the sample size is not indicated.
  • Data Provenance: Implied internal testing, likely at Siemens R&D facilities. No external patient data provenance details are given.

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

• For FAST Bolus, the "ground truth" for the internal bench test was defined as an "ideal post bolus delay" determined by measurements with a dynamic scan mode. This suggests an objective, data-driven approach rather than expert consensus on individual cases for the initial ground truth. However, the supporting studies mention:
  • Hinzpeter et al. (2019): Mentions subjective image quality and CNR, which would typically involve expert readers, but the number and qualifications are not provided.
  • Yuan et al. (2023): Mentions "Both readers rated better subjective image quality." suggesting at least two readers, but their qualifications are not provided.
• For other features (FAST 3D Camera, FAST Planning, etc.), the ground truth seems to be established through objective measurement against predefined targets (e.g., "calculated by FAST Planning algorithm that are correct and can be applied without change"). No specific expert involvement for ground truth establishment for these features is detailed.

4. Adjudication Method for the Test Set

• The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the establishment of ground truth or for reader studies. Where multiple readers are mentioned (e.g., Yuan et al. for FAST Bolus), it only states their findings without detailing an adjudication process. This suggests either independent readings or consensus where needed, but not a formal adjudication protocol.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

• Yes, implicitly for FAST Bolus: The supporting publications function as comparative effectiveness studies where human assessment (e.g., subjective image quality, diagnostic confidence) is evaluated with or without the aid of the FAST Bolus prototype.
  • Hinzpeter et al. (2019): "higher overall and more uniform attenuation in the individualized cohort compared to the fixed cohort. No difference between the cohorts for image noise was found, but a higher contrast-to-noise ratio (CNR) and higher subjective image quality in the individualized cohort compared to the fixed cohort." This indicates improvement with the AI-assisted timing.
  • Yu et al. (2021): "In the arterial phase, the images of group A with the individualized post-trigger delay provided higher attenuation for all organs... Furthermore, the contrast-to-noise ratio (CNR) of liver, pancreas and portal vein were significantly higher in the group with the individualized scan timing compared to the fixed scan delay. The overall subjective image quality and diagnostic confidence between the two groups were similar." This indicates improved quantitative metrics, with subjective similar.
  • Yuan et al. (2023): "Both readers rated better subjective image quality for Group B with the individualized scan timing. Also, the mean vessel enhancement was significantly higher in Group B in all coronary vessels. After adjusting for the patient variation, the FAST Bolus prototype was associated with an average of 33.5 HU higher enhancement compared to the fixed PTD." This provides a direct effect size for enhancement.
• For the other features, the description is focused on the device's inherent performance (e.g., accuracy of landmark detection, successful implementation) rather than human reader improvements. So, no MRMC study for those.

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

• Yes, for multiple features. The "Bench Testing" descriptions primarily evaluate the algorithm's performance in a standalone manner against a defined ground truth or objective:
  • FAST Bolus: "the post bolus delay as calculated by FAST Bolus to an ideal post bolus delay... was calculated. The objectives of the test were to investigate the deviation from the post bolus delay as determined by FAST Bolus to an ideal/ground truth delay..." This is standalone.
  • FAST 3D Camera, FAST Isocentering, FAST Range, FAST Direction: The tests "demonstrate that the FAST 3D Camera feature... achieves comparable or more accurate results," "lateral isocenter accuracy... comparable," "robustness of the groin landmark is improved," "comparable accuracy of the pose detection." These are assessments of the algorithm's direct performance.
  • FAST Planning: "assess the fraction (percentage) of ranges calculated by the FAST Planning algorithm that are correct and can be applied without change." This is a direct measurement of the algorithm's output quality.
  • Tin Filtration: Verifies "successful implementation" and investigates "improved contrast-to-noise ratio (CNR) in spectral results." This is standalone performance of the image reconstruction/processing.

7. The Type of Ground Truth Used

• Objective/Measured Data:
  • FAST Bolus: "ideal post bolus delay" determined by "measurements with a dynamic scan mode" and "averaged dynamic scans."
  • FAST 3D Camera, FAST Isocentering, FAST Range, FAST Direction: Implied ground truth based on objective measurements of spatial accuracy relative to predefined targets or phantoms.
  • FAST Planning: "correct" ranges are the ground truth, implying comparison to a predefined standard or ideal plan.
  • Tin Filtration: Objective image quality criteria and spectral property measurements are used as ground truth indicators.
• Expert Consensus/Subjective Assessment (as secondary metric in supporting studies): Some of the supporting publications for FAST Bolus also incorporate subjective image quality ratings by human readers, which would likely involve some form of expert consensus or individual expert assessment.

8. The Sample Size for the Training Set

• The document does not provide information on the sample size used for the training set for any of the AI/algorithm features. This information is typically proprietary and not usually disclosed in a 510(k) summary unless specifically requested or deemed critical for demonstrating substantial equivalence.

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

• The document does not provide information on how the ground truth for the training set was established. Given the nature of these features (automated bolus timing, patient positioning, scan range planning), the training data would likely involve large datasets of CT scans annotated with physiological events, anatomical landmarks, and optimal scan parameters. These annotations would typically be established by highly qualified medical professionals (e.g., radiologists, technologists) or through automated processes validated against gold standards. However, the specific methodology is not detailed in this excerpt.

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The SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) is a portable battery powered vacuum source / waste container intended for the removal of surgical and bodily fluids from a closed wound following plastic surgery and other general surgery forming large flaps for hematoma and seroma prophylaxis. It is intended for use in homecare and healthcare environments.

The SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) is a portable, batterypowered vacuum pump/waste container intended for the removal of surgical and bodily fluids from a closed wound following plastic surgery and other general surgery forming large flaps for hematoma and seroma prophylaxis. It is intended for homecare and healthcare environments. The SOMAVAC® 100 may be used for most instances a surgeon determines a closed suction drain device is applicable. The SOMAVAC® 100 is compatible with drains commonly used after surgeries and is intended to be used by a single patient. The SOMAVAC® 100 is to be installed by trained medical personnel. Post-installation (in patient setting or at home), the SOMAVAC® 100 is intended to be operated by patients or their caregivers.

The provided text is related to the FDA 510(k) clearance for the SOMAVAC® 100 Sustained Vacuum System. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's clinical performance against specific acceptance criteria for a novel AI or diagnostic system.

Therefore, many of the requested categories in your prompt cannot be fully addressed from the provided text. The document describes changes to a previously cleared device (SOMAVAC® 100, K222856) specifically regarding an additional sterilization method (ethylene oxide) for its drain connector accessories. The performance testing section focuses on validating this new sterilization method and its impact on packaging.

Here's an attempt to answer your questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are not presented in a table format for a clinical outcome or diagnostic accuracy in this document. Instead, the "performance testing" focuses on validating the sterilization method and its effects on packaging integrity, referencing existing standards. The acceptance criteria essentially reflect compliance with these standards.

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

The document does not specify a "test set" in the context of patient data or algorithm performance. The testing mentioned relates to the physical and chemical properties associated with the new sterilization method and packaging. Therefore, no information on sample size for a "test set" for device performance (e.g., fluid removal efficiency in patients) or data provenance (country, retrospective/prospective) is available.

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

Not applicable. The document does not describe a test set requiring expert-established ground truth for clinical or diagnostic performance. The validation of sterilization and packaging integrity would typically involve laboratory testing by qualified personnel, but not "experts" in the sense of clinicians establishing ground truth from patient data.

4. Adjudication method for the test set

Not applicable. There is no mention of an adjudication method as the testing concerns physical and chemical properties of the device components/packaging, not clinical or diagnostic outcomes requiring expert consensus.

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

Not applicable. This device is a powered suction pump, not an AI or diagnostic tool that would involve human readers or image interpretation.

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

Not applicable. This device is a physical medical device (suction pump), not an algorithm or AI system.

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

For the performance testing related to the new sterilization method, the "ground truth" is established by adherence to recognized international standards (ISO 11135, ISO 10993-7, ASTM F88/F88M, ASTM 1886). These standards define acceptable parameters for sterilization efficacy, residuals, and packaging integrity.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As above, there is no training set for this device.

Summary of Device Performance (from the document):

The SOMAVAC® 100 Sustained Vacuum System, in this submission (K231063), is essentially the same device as its predicate (K222856). The only change covered by this 510(k) is the addition of Ethylene Oxide (EO) as a sterilization method for the drain connector accessories, alongside the existing gamma radiation method.

The study presented here focuses on validating this new sterilization method and confirming that it does not negatively impact the device's safety or effectiveness. This was achieved by demonstrating compliance with ISO standards for EO sterilization and biological evaluation, and by conducting packaging evaluations (seal strength and integrity) post-sterilization, which all "Passed". The conclusion is that the device remains substantially equivalent to the predicate.

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The SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) is a portable battery powered vacuum source / waste container intended for the removal of surgical and bodily fluids from a closed wound following plastic surgery and other general surgery forming large flaps for hematoma and seroma prophylaxis. It is intended for use in homecare and healthcare environments.

The SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) is a portable battery-powered vacuum pump/waste container intended for the removal of surgical and bodily fluids from a closed wound following plastic surgery and other general surgery forming large flaps for hematoma and seroma prophylaxis. It is intended for homecare and healthcare environments. The SOMAVAC® 100 may be used for most instances a surgeon determines a closed suction drain device is applicable. The SOMAVAC® 100 is compatible with drains commonly used after surgeries and is intended to be used by a single patient. The SOMAVAC® 100 is to be installed by trained medical personnel. Post-installation (in patient setting or at home), the SOMAVAC® 100 is intended to be operated by patients or their caregivers.

This document details a 510(k) premarket notification for the SOMAVAC® 100 Sustained Vacuum System. It establishes substantial equivalence to a predicate device, K180606.

Here’s an breakdown of the acceptance criteria and study information provided:

Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of "acceptance criteria" against which a clinical performance study would be evaluated in terms of sensitivity, specificity, accuracy, or similar metrics. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (SOMAVAC® Device, K180606) through non-clinical performance testing and direct comparison of specifications.

The "performance" described refers to the device's functional characteristics and compliance with standards, rather than diagnostic or treatment efficacy from a clinical study. The table below summarizes the key comparisons made to demonstrate substantial equivalence, which serves as the "acceptance criteria" for this type of regulatory submission in the absence of a new clinical claim.

Study Information

The document describes non-clinical testing rather than a traditional “study” with patient data.

1. Sample size used for the test set and the data provenance: Not applicable. This submission relies on non-clinical performance verification and validation. The "test set" would refer to the physical devices and components tested. The provenance is not explicitly stated in terms of country of origin of "data," but it implicitly comes from the manufacturer's internal testing. The testing is prospective in the sense that the new device was built and then tested.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For non-clinical performance testing of a physical device like this, "ground truth" is established by engineering specifications, validated measurement equipment, and industry standards (e.g., electrical safety, EMC). Expert review would be part of the design and verification processes but not as a formal "ground truth" for a test set in the clinical sense.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This type of adjudication is typically used in clinical studies for interpretation of imaging or clinical outcomes, not for engineering performance testing.

4. 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: Not applicable. This device is a powered suction pump, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or cases in an MRMC study.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a hardware product. While it contains software, the performance listed is for the complete system.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical testing is based on:

   • Engineering specifications: The defined parameters for vacuum, flow, electrical characteristics, and physical properties.
   • Regulatory standards: Compliance with voluntary standards for electrical safety (e.g., IEC 60601-1), electromagnetic compatibility (e.g., IEC 60601-1-2), and powered suction pumps (e.g., ISO 10079-1).
   • Previous device performance: The performance of the predicate device (K180606) served as a benchmark for equivalence.

7. The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires a training set. The software changes were validated in accordance with FDA guidances for software in medical devices, but this is distinct from training an AI model.

8. How the ground truth for the training set was established: Not applicable. (See answer to point 7).

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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 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 by computer reconstruction of x-ray transmission data within a 25 cm field-of-view, primarily for the head and neck.

The images delivered by SOMATOM On.scene can be used by a trained physician as an aid in diagnosis.

The Siemens SOMATOM On scanners are comprised of a Computed Tomography (CT) Scanner System (SOMATOM On.scene) which can be mounted on an optional motorized base (SOMATOM On.site). The CT scanner features one continuously rotating tube-detector system that functions according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

The SOMATOM On scanners produce CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens and other vendors as an aid in diagnosis and treatment preparation. The computer system included in the CT Scanner is able to run optional post processing applications.

The software version for the SOMATOM On scanner system is Somaris/10 syngo CT VA35A, 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 VA35A is designed to provide a plugin interface to integrate potential advanced post processing tasks, tools, or extendable functionalities.

As with the primary predicate device, the SOMATOM On. Scanners will be available in a 32 row, 32 slice configuration.

This FDA 510(k) submission for the SOMATOM On.site and On.scene CT systems does not contain specific acceptance criteria or a study directly aimed at proving algorithm performance against a pre-defined set of metrics. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical testing, phantom studies, and adherence to various industry standards and guidance documents.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for specific quantitative performance metrics of an AI algorithm, nor does it report the device performance against such criteria. The "Performance Data" section discusses:

• Non-Clinical Testing (Integration and Functional): Included phantom tests and volunteer human scans.
• Electrical Safety and EMC Testing: Conformance to IEC 60601-1, 60601-2-44, and 60601-1-2 standards.
• Radiation Safety Testing: "Under published limits," with the protection curtain reducing radiation significantly.
• Usability Testing: Formative and Summative evaluations, identifying "No new use errors, hazards or hazardous situations."
• Imaging Studies: Phantom scans (adult heads, pediatric bodies, pediatric heads) and volunteer scans (brain with/without contrast, ankle, hand). All imaging results were "as expected and were determined by a board-certified radiologist to be of high diagnostic quality." This last point is the closest to a performance statement, but it's qualitative and without specific acceptance thresholds.

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

• Test Set Sample Size: Not explicitly stated. The document mentions "phantom tests and volunteer human scans" for non-clinical testing and "phantom scans... Additionally, volunteer scans" for imaging studies. There is no quantification of the number of volunteers or specific phantom cases used for performance evaluation that could be considered a "test set" for an AI algorithm.
• Data Provenance: Not explicitly stated. The document doesn't specify the country of origin for the volunteer scans or if the data was retrospective or prospective. Given that this is a Siemens product with manufacturing in Germany and sales in the US, the volunteer data could be from either region.

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

• Number of Experts: For the imaging studies, it states: "All imaging results were as expected and were determined by a board-certified radiologist to be of high diagnostic quality." This implies at least one board-certified radiologist provided an opinion.
• Qualifications: "board-certified radiologist." No specific experience level (e.g., "10 years of experience") is mentioned.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth from multiple experts. The statement "determined by a board-certified radiologist" suggests a single expert assessment for the imaging quality.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on how human readers improve with AI vs. without AI assistance was not mentioned or performed. The submission is for the CT system itself, not an AI-powered diagnostic aid that assists human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document describes the CT system as providing images that "can be used by a trained physician as an aid in diagnosis." It also states "The computer system included in the CT Scanner is able to run optional post processing applications." While the software platform (SOMARIS/10 syngo CT VA35A) is designed to "provide a plugin interface to integrate potential advanced post processing tasks, tools, or extendable functionalities," the submission does not describe the performance of any specific standalone AI algorithm (i.e., operating without human-in-the-loop for diagnosis). The focus is on the CT system's ability to produce diagnostically acceptable images.

7. The Type of Ground Truth Used

For the imaging studies described, the ground truth was based on expert consensus/opinion (specifically, a "board-certified radiologist" determining "high diagnostic quality"). There is no mention of pathology or outcomes data being used as ground truth for the device's image quality evaluation.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This is consistent with the submission not detailing the performance of a specific AI algorithm for diagnostic aid, but rather the CT system's foundational image generation capabilities. The software updates mentioned are primarily for mobile workflow adaptation and hardware/reconstruction support, not a defined AI model.

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

Since no training set is discussed, there is no information on how ground truth was established for it.

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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 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.

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