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The Siemens Biograph systems are combined x-ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of physiologic and anatomic information.

The CT component produces cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images.

The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and/or PET diagnostic imaging.

These systems are intended to be utilized by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease, and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders, and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

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 Biograph Vision.X and Biograph Vision.X Edge PET/CT systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. This system is designed for whole body oncology, neurology and cardiology examinations. The Biograph Vision.X and Biograph Vision.X Edge PET/CT systems provide registration and fusion of highresolution metabolic and anatomic information from the two major components of each system (PET and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software.

Biograph Vision.X and Biograph Vision.X Edge software is a command-based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.

The Biograph Vision.X and Biograph Vision.X Edge scanners are based on the Biograph Vision 600 and Biograph Vision 600 Edge scanners. The primary difference between the Bigoraph Vision 600 / Vision 600 Edge and Biograph Vision.X / Vision.X Edge scanners is an update to the PET detector electronics assembly (DEA) to provide for better NEMA Time of Flight Resolution.

The software for the Biograph Vision.X and Biograph Vision.X Edge PET/CT system, which is the subject of this application, is substantially equivalent to the commercially available Biograph Vision 600 / Vision 600 Edge software (K193248). Modifications have been made to the commercially available Biograph Vision software to provide for the additional two Biograph Vision configurations. All features and functionality of the Biograph Vision.X and Biograph Vision.X Edge scanners are the commercially available Biograph Vision 600 and Biograph Vision 600 Edge PET/CT scanners (K193248).

The provided text describes the regulatory submission for the Siemens Biograph Vision.X and Biograph Vision.X Edge PET/CT systems. The primary focus is on demonstrating substantial equivalence to a predicate device and outlining performance testing for the PET subsystem.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. A table of acceptance criteria and the reported device performance:

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

The document states that "PET Testing in accordance with NEMA NU2-2018 was conducted on the Biograph Vision Quadra system." NEMA NU2-2018 is a standard for performance measurements of PET systems, which typically involves phantom studies rather than human patient data. Therefore, there is no sample size of patients mentioned, nor is there any information about data provenance (country of origin, retrospective/prospective) because the testing described is primarily physical performance testing using standardized phantoms.

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

Since the testing is physical performance testing using phantoms (per NEMA NU2-2018), there were no human experts involved in establishing ground truth in the way medical image interpretation would require. The ground truth for these measurements is typically defined by the physical characteristics of the phantom and the known properties of the radioactive source used, measured by precise physical instruments.

4. Adjudication method for the test set:

Not applicable, as the testing involves physical measurements against defined engineering specifications, not expert consensus on medical images.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study was performed or reported in this document. The submission focuses on the technical performance of the PET/CT system itself, not on AI-assisted interpretation or its impact on human readers. The provided text indicates that the device itself is a PET/CT scanner, not an AI interpretation device.

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

The device described is a PET/CT system, which acquires imaging data. It is not an algorithm for image interpretation in the sense of a standalone AI system. The performance testing outlined (NEMA NU2-2018) evaluates the physical characteristics and image quality of the scanner, not the performance of an interpretive algorithm. Therefore, this question is not applicable in the context of the provided information.

7. The type of ground truth used:

The ground truth for the performance testing cited (NEMA NU2-2018) is based on physical phantom measurements and engineering specifications. These are objective, quantitative measurements of the scanner's performance using standardized phantoms.

8. The sample size for the training set:

Not applicable. The document describes a PET/CT imaging device, not a machine learning model that requires a training set of data.

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

Not applicable, as this is not a device based on machine learning that requires a training set with established ground truth.

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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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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.

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The Siemens Biograph Vision Quadra PET/CT systems are combined Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration of high resolution physiologic and anatomic information.

The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images.

The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and /or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

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 Biograph Vision Quadra PET/CT systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. These systems are designed for whole body oncology, neurology and cardiology examinations. The Biograph Vision and systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software.

Biograph Vision Quadra software is a command-based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.

The Biograph Vision Quadra is an extended Field of View scanner based on the Biograph Vision 600 Edge scanner. The system incorporates the same CT on the Biograph Vision 600 Edge but incorporates a 106 cm axial PET FoV. The gantry mechanical frame has been updated to support four (4) times the detectors available on the Biograph Vision 600 systems.

The software for the Biograph Vision Quadra systems, which are the subject of this application, is substantially equivalent to the commercially available Biograph Vision software (K193248). Modifications have been made to the commercially available Biograph Vision software to provide for acquisition and reconstruction of the additional detectors associated with the extended axial FoV of the PET system.

Additionally, modifications have been made to the PET computers to ensure that the system computing can handle the amount of data received from the 1 m scan range system.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The performance testing was conducted according to NEMA NU2-2018 standards, which typically involve testing on phantoms rather than human or animal subjects.

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

The document does not mention the use of experts to establish a ground truth for the test set. The performance testing appears to be based on objective measurements against NEMA NU2-2018 industrial standards, which are defined by physical phantoms and measurement protocols, not expert consensus on pathology or clinical outcomes.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as the testing involves objective physical measurements against established standards (NEMA NU2-2018) rather than subjective assessments by experts.

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

No MRMC comparative effectiveness study is mentioned. The document describes performance testing of the device's physical and technical characteristics, not its performance in a clinical setting with human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The performance testing described is for the "algorithm only" (i.e., the Biograph Vision Quadra PET/CT System's technical performance) without a human reader in the loop. The "Results" column indicating "Pass" for all tested criteria confirms that the system, as a standalone device, met the predetermined acceptance values.

7. Type of Ground Truth Used

The ground truth used for the performance testing is based on the NEMA NU2-2018 standard. This standard specifies phantoms and measurement protocols to objectively evaluate the physical performance characteristics of PET systems. It is not based on expert consensus, pathology, or outcomes data, but rather on direct physical measurements against defined benchmarks.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of the described performance testing. The Biograph Vision Quadra PET/CT System is a medical imaging device (hardware and associated software), and the performance testing focuses on its physical and technical specifications rather than an AI model that undergoes a training phase. While there is software development involved ("Modifications have been made to the commercially available Biograph Vision software"), the document does not detail specific training data for that software in the context of this performance evaluation.

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

As no training set is described in the context of the performance testing for this device's NEMA NU2-2018 criteria, information on how its ground truth was established is not provided.

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The Siemens Biograph Vision and Biograph mCT PET/CT systems are combined X-Ray Computed Tomography (CT) and Position Emission Tomography (PET) scanners that provide registration of high resolution physiologic and anatomic information.

The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images.

The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

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 Biograph Vision and Biograph mCT PET/CT systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. These systems are designed for whole body oncology, neurology and cardiology examinations. The Biograph Vision and Biograph mCT systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software.

Biograph Vision and Biograph mCT software is a command-based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.

The software for the Biograph Vision and Biograph mCT systems which are the subject of this application is substantially equivalent to the commercially available Biograph Vision and Biograph mCT software. Modifications include, corrections to software anomalies and addition of new software features, including:

• OncoFreeze AI (Data Driven Gating)
• FlowMotion Al (PET FAST Planning)
• FAST PET Workflow
• Updates to HD FoV
• . Updates to PET DICOM dose Report
• Whole Body Scatter Correction (for Biograph Vision)

Additionally, minor modifications have been made to the computers due to obsolescence issue. These changes do not affect system performance characteristics and have no impact on safety or effectiveness.

The provided text describes performance testing for the Biograph Vision PET/CT and Biograph mCT PET/CT systems, which are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners. The testing was conducted in accordance with NEMA NU2-2018 for the PET subsystem.

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

1. Table of Acceptance Criteria and Reported Device Performance

For Biograph Vision (6-ring and 8-ring configurations):

For Biograph mCT (3-ring and 4-ring configurations):

Additional Features Performance (Acceptance Criteria implicitly met by "Pass" or comparison):

OncoFreeze AI (Data Driven Gating)

The document states: "An evaluation of change in SUVmax, SUVmean and volume measurement has been performed comparing Anzai based OncoFreeze and OncoFreeze AI." The implication is that OncoFreeze AI's performance is comparable and acceptable.

FlowMotion AI (PET FAST Planning)

The document states: "Successful identification of all ranges in a FlowMotion AI configuration ranged from 87.1% to 100%, dependent on the configuration set." This implies the high accuracy is considered acceptable.

Whole Body Scatter Correction (for Biograph Vision)

The document states: "An evaluation was performed to evaluate ROI's using single bed scatter compared to whole body scatter." This table demonstrates significantly improved accuracy with Whole Body Scatter correction, implying its acceptance.

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

The document indicates that PET testing was carried out on two different configurations of the Biograph Vision systems (a 6-ring and an 8-ring version) and two configurations of the Biograph mCT (a 3-ring and a 4-ring version). These are physical devices/configurations being tested, not patient data sets. The testing for the core PET performance criteria (Resolution, Count Rate, Image Quality, Co-registration Accuracy) was conducted using NEMA NU2-2018 standards. This standard uses phantoms, not human patient data.

For the AI-powered features:

• OncoFreeze AI (Data Driven Gating): An evaluation was performed comparing OncoFreeze AI to Anzai-based OncoFreeze. The data provenance is not specified, nor is the sample size (number of patients or scans). The data is presented as statistical metrics (mean and standard deviation of percentage change) suggesting a dataset with multiple measurements.
• FlowMotion AI (PET FAST Planning): Testing was done to evaluate accuracy in defining bed ranges. The results are presented as a range of percentages (87.1% to 100%) "dependent on the configuration set." The sample size or data provenance (e.g., retrospective/prospective, country of origin) is not specified.
• Whole Body Scatter Correction: An "evaluation was performed to evaluate ROI's using single bed scatter compared to whole body scatter." This was a simulation study of phantom.

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

• For the core PET performance criteria (NEMA NU2-2018), ground truth is established through physical measurements of phantoms according to standardized protocols, not expert consensus.
• For the AI-powered features (OncoFreeze AI, FlowMotion AI, Whole Body Scatter Correction), the document does not mention the involvement of experts for establishing ground truth.
  • For OncoFreeze AI, the ground truth for comparison seems to be "static" measurements and the "Anzai-based OncoFreeze" system.
  • For FlowMotion AI, the "correct" bed ranges are likely determined by system specifications or a reference method, not necessarily human experts.
  • For Whole Body Scatter Correction, the "ground truth" was established in a "simulation study of phantom."

4. Adjudication method for the test set

No adjudication method for expert consensus is described because the primary performance testing relies on standardized phantom measurements (NEMA NU2-2018) or comparisons to existing system outputs/simulated phantom ground truth for the AI features.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study is mentioned. The studies described focus on device performance characteristics (resolution, sensitivity, image quality) and the performance of new AI algorithms in terms of measurement accuracy or task completion. There is no information provided about human reader performance with or without AI assistance.

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

Yes, the studies focusing on the AI-powered features (OncoFreeze AI, FlowMotion AI, Whole Body Scatter Correction) appear to be standalone algorithm performance evaluations. The metrics provided (ΔSUV, ΔVolume, accuracy of bed range definition, difference from ground truth in scatter correction) are direct outputs of the algorithms, without explicit human-in-the-loop evaluation of these outputs as part of the reported performance metrics.

7. The type of ground truth used

• For core PET performance (NEMA NU2-2018): Phantom measurements/specifications.
• For OncoFreeze AI: Comparative measurements against "static" scans and an "Anzai-based OncoFreeze" system. The "ground truth" here is relative rather than an absolute truth from pathology or long-term outcomes.
• For FlowMotion AI: Implicitly, the system's intended or ideal definition of bed ranges. Not explicitly stated where this "ground truth" originated.
• For Whole Body Scatter Correction: "Ground truth" established in a simulation study of phantom.

8. The sample size for the training set

The document does not specify the sample size for the training set for any of the AI-powered features. It only describes the performance evaluation (test set performance).

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 for any of the AI-powered features.

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