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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 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, 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 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.

• Somaris Software (cleared in K230421)
  • Upgrade to the latest revision of Somaris Software (Somaris/7 syngo CT VB30) with modified software features:
    • FAST Bolus
    • FAST 4D
    • FAST Applications (FAST Spine, FAST Planning)
    • Automatic Patient Instructions
    • Additional default exam protocols
    • Additional kV setting for Tin Filtration
• PETsyngo software
  • SMART Image Framer (available for Vision 600 and X models only – cleared in K223547)
• Updated computer hardware due to obsolescence issues (cleared in K230421). These changes do not affect system performance characteristics and have no impact on safety or effectiveness.

The Biograph Vision may also use the names Biograph Vision Quantum and Peak for marketing purposes.

Here's an analysis of the provided FDA 510(k) clearance letter for Siemens Biograph Vision and mCT PET/CT Systems, focusing on acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the performance of the updated software (VG85) for the Siemens Biograph Vision and Biograph mCT PET/CT Systems, comparing it to the predicate device (VG80). The "Acceptance Criteria" for the subject device are explicitly stated as "Same" as the predicate device's performance values. This implies that the updated system must perform at least as well as the predicate device across all tested metrics.

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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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The Siemens Biograph Vision Quadra systems are combined X-Ray Computed Tomography (CT) and Position Emission Tomography (PET) scanners that provide registration and fusion 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 system is a combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanner. This system is designed for whole body oncology, neurology and cardiology examinations. The Biograph Vision Quadra system provides 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 PET/CT system, which is the subject of this application, is substantially equivalent to the commercially available Biograph Vision Quadra software (K210262). Modifications have been made to the commercially available Biograph Vision Quadra software to provide for additional features that are already commercially available in the reference device Biograph Vision software (K193248). These include the following features:

• Gated List Mode (HD Chest)
• Simultaneous Mode
• Continuous Bed Motion
• Shuttle Mode PET Acquisition
• . FlowMotion Al (PET FAST Planning)
• FlowMotion MultiParametric PET Al
• OncoFreeze Motion Correction
• OncoFreeze Al
• Quality Guard

Additionally, the following new features have been implemented into the updated Software:

• PET SMART Image Framer (workflow improvement to focus on specific body area) -PET Reconstruction
• . Ultra-High Sensitivity Reconstruction - PET Reconstruction

The provided text describes the Siemens Biograph Vision Quadra PET/CT System (K223547). The acceptance criteria and performance study details are presented in the "Performance Testing / Safety and Effectiveness" section.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides two tables (Table 1 and Table 2) outlining the PET NEMA 2018 Performance Summary for the Biograph Vision Quadra with different Maximum Ring Differences (MRD). Both tables show that the device met all predetermined acceptance values.

Table 1: PET NEMA 2018 Performance Summary Biograph Vision Quadra with a Maximum Ring Difference (MRD) of 85.

Table 2: PET NEMA 2018 Performance Summary Biograph Vision Quadra with a Maximum Ring Difference (MRD) of 322.

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 the performance measurements of PET and PET/CT scanners using standardized phantom measurements. This implies the "test set" consists of phantom-based measurements, not patient data. Therefore, the concept of data provenance (country of origin, retrospective/prospective) and sample size in the traditional clinical trial sense for human data is not directly applicable here. The test is a technical performance validation using a single device and standardized phantom setups.

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

Since the study is based on NEMA NU2-2018 phantom testing, the ground truth is established by the physical and measurable properties of the phantoms and the precise adherence to the NEMA standard protocols. This does not involve human expert interpretation of images for establishing ground truth, as would be the case for AI-based diagnostic devices.

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

Not applicable. As noted above, the study is a technical performance validation using standardized phantom measurements, not a clinical study requiring human adjudication of findings.

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. The description focuses on the technical performance of the PET/CT system itself (image resolution, sensitivity, count rates, etc.) rather than the performance of an AI algorithm or its impact on human reader performance. There is no mention of AI assistance in relation to diagnostic accuracy for human readers. While the device does have "AI" features listed (e.g., FlowMotion AI, OncoFreeze AI), the presented performance testing is for the core PET/CT system metrics, not a human-in-the-loop AI effectiveness study.

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

Not applicable in the context of an AI algorithm's standalone performance. The standalone performance presented is for the PET/CT imaging system itself, demonstrating its ability to meet physical imaging quality and sensitivity metrics as specified by the NEMA standard.

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

The ground truth for this device performance study is based on physical phantom measurements and the defined parameters of the NEMA NU2-2018 standard. The acceptance criteria are quantitative values derived from these physical measurements.

8. The sample size for the training set:

Not applicable. This is a performance validation study of a PET/CT scanner, not a machine learning model that requires a training set.

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

Not applicable. As this is not a study involving a machine learning model, there is no training set or associated ground truth establishment process.

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

The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray wansmission 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 approxiately trained health care professionals to aid in detecting. 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 Lune Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

The Biograph Vision systems are combined multi-slice X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners. These systems are designed for whole body oncology, neurology and cardiology examinations.

The Biograph Vision 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 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 PET/CT, which is the subject of this application, is substantially equivalent to the commercially available Biograph Vision PET/CT (K180811). The key differences between the current Biograph Vision (predicate device) and the Biograph Vision PET/CT that is the subject of this application is the addition of two new models (Biograph Vision 450 and Biograph Vision 450 Edge) with a smaller axial PET Field of View, as well as additional software modifications to daily / weekly Quality Control that is applicable to all models of the Biograph Vision.

The provided text describes the acceptance criteria and performance of the Siemens Biograph Vision PET/CT system, which is a combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanner. This is a 510(k) premarket notification for a medical device; therefore, the "study" proving acceptance is primarily a technical performance evaluation against established industry standards and comparison to a predicate device, rather than a clinical trial with human subjects for AI assistance.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The performance testing for the PET component was conducted in accordance with NEMA NU2:2018.

Device: Biograph Vision PET/CT (specifically models 450/450 Edge and 600/650 Edge are mentioned, performance results are generic for both where ranges are the same, or specific to each model where they differ).

Ask a specific question about this device

The Siemens Biograph Vision PET/CT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion 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 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 systems are combined multi-slice X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners. These systems are designed for whole body oncology, neurology and cardiology examinations.

The Biograph Vision 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 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 PET/CT, which is the subject of this application, is substantially equivalent to the commercially available Biograph mCT (K173578). The key difference between the Biograph mCT (predicate device) and the Biograph Vision PET/CT is the replacement of PhotoMultiplier Tubes (PMT) with Silicon PhotoMultipliers (SiPM). SiPMs are a photon sensitive technology built by combining a solid state photodiode array and a silicon substrate. The SiPMs allow close coupling to the scintillators (crystals) and a higher active area of detectors to scintillators. This combination results in superior performance compared to the photomultiplier tubes design used in previous generation PET block detectors.

The provided text is a 510(k) Summary for the Siemens Biograph Vision PET/CT system. It details the device, its intended use, and performance testing results to demonstrate substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance:

The document primarily focuses on the physical performance characteristics of the PET component of the Biograph Vision system, tested according to NEMA NU2:2012 standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The study described is Performance Testing in accordance with NEMA NU2:2012, conducted on the Biograph Vision 600.

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

• Sample Size: The document does not specify a "sample size" in terms of patient images or clinical cases. The testing appears to involve physical phantoms and measurements as per NEMA NU2:2012 standards, not a clinical test set of patient scans. Therefore, sample size in the context of clinical images is not applicable here.
• Data Provenance: Not applicable as this is performance testing of the device itself using phantom measurements, not clinical data collection. The testing was conducted by Siemens Medical Solutions USA, Inc.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. The ground truth for this type of performance testing is defined by the NEMA NU2:2012 standard itself, which specifies the phantoms, measurement procedures, and calculation methods. It does not involve human expert interpretation for establishing ground truth.

4. Adjudication Method for the Test Set:
Not applicable. As the testing involves objective physical measurements and calculations based on a recognized standard (NEMA NU2:2012), there is no need for human adjudication of results.

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, an MRMC comparative effectiveness study was not done. The document describes a PET/CT scanner and its physical performance, not an AI-powered diagnostic tool requiring human reader studies to demonstrate improved performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, in a sense, the performance testing described is "standalone" for the device's physical capabilities. The NEMA NU2:2012 tests evaluate the intrinsic imaging performance of the PET component (resolution, sensitivity, count rate, image quality based on phantom measurements) without human interpretation in the loop.

7. The Type of Ground Truth Used:
The ground truth used for this performance testing is the physical properties and known measurements of standardized phantoms as defined by the NEMA NU2:2012 standard. This is a technical ground truth, not a medical ground truth (like pathology, expert consensus, or outcomes data).

8. The Sample Size for the Training Set:
Not applicable. This is a hardware device (PET/CT scanner), not a machine learning algorithm that requires a "training set" of data for development.

9. How the Ground Truth for the Training Set was Established:
Not applicable for the same reason as above.

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