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

• OncoFreeze
• OncoFreeze AI (Data Driven Gating)
• CardioFreeze
• FlowMotion Multi-Parametric PET AI ●
• PET FAST Planning (FlowMotion Al)
• FAST PET Workflow
• QualityGuard
• . Updates to HD FoV
• Updates to PET DICOM dose Report
• Whole Body Scatter Correction

Additionally, minor modifications have been made to the computers due to obsolescence issues and to the controllers of the PHS for cost improvement. These changes do not affect system performance characteristics and have no impact on safety or effectiveness.

The Siemens Biograph Horizon PET/CT system (K193178) underwent performance testing against NEMA NU2-2018 standards for its PET subsystem. The device also had specific evaluations for new software features: OncoFreeze AI, OncoFreeze/CardioFreeze, FlowMotion Multi-Parametric PET AI, FlowMotion AI (PET FAST Planning), QualityGuard, and Whole Body Scatter Correction.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• PET Testing (NEMA NU2-2018): The document implies physical phantom testing which is standard for NEMA NU2-2018. The number of samples (scans or measurements) from the phantom is not explicitly stated, but these tests are typically performed on two different configurations: a 3-ring version and a 4-ring version (TrueV). Data provenance is from physical phantom measurements on the device itself.
• OncoFreeze AI (Data Driven Gating): The document mentions "motion-corrected (OncoFreeze) images comparing Anzai based gating and deviceless gating." It does not specify the number of patient images or specific phantom studies. The provenance isn't explicitly stated as retrospective or prospective, nor a country of origin.
• FlowMotion AI (PET FAST Planning): No specific sample size (i.e., number of cases or scans) is given. The study evaluated "configuration set" effectiveness. The provenance is not explicitly stated.
• Whole Body Scatter Correction: This was a "simulation study of phantom." The sample size (number of ROIs or simulation runs) is not specified. Provenance is simulation data based on a phantom.

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

• For the NEMA NU2-2018 PET testing, the ground truth for performance metrics (resolution, sensitivity, scatter fraction, image quality) is established by the known physical properties and activity concentrations of the NEMA phantom according to the standard. No human experts are involved in establishing this ground truth.
• For OncoFreeze AI, the "ground truth" for motion correction comparison is implicitly the static image or the Anzai-based gated images acting as a reference for comparison of SUV and Volume changes. No explicit expert involvement for ground truth is mentioned.
• For FlowMotion Multi-Parametric PET AI, the "ground truth" for improved noise characteristics and delineation is a comparison against the Patlak transformation performed during reconstruction without the automatic feature. This implies qualitative assessment, but no expert details are given.
• For FlowMotion AI (PET FAST Planning), the "ground truth" for correctly defined bed ranges would be based on the known or intended bed ranges. No expert involvement in establishing this ground truth is mentioned.
• For QualityGuard, the "ground truth" for time savings and exposure reduction would be direct measurement or comparison to previous workflows. No expert involvement for ground truth is mentioned.
• For Whole Body Scatter Correction, "ground truth" was established by a "simulation study of phantom," implying that the true values for activity in different regions of interest were known from the simulation setup. No human experts are involved in establishing this ground truth; it's inherent to the simulation.

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

No adjudication method for expert review of images or data is mentioned for any of the tests described. The tests are primarily technical performance evaluations (NEMA standards, quantitative comparisons, simulation studies) or workflow efficiency observations.

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 multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with AI assistance is mentioned in the provided text. The AI features mentioned (OncoFreeze AI, FlowMotion Multi-Parametric PET AI, FlowMotion AI (PET FAST Planning)) are related to image processing and workflow automation rather than direct diagnostic assistance for human readers in a comparative effectiveness setting.

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

The device itself is a diagnostic imaging system (PET/CT), not an AI algorithm that provides a diagnostic output to a human. The AI features described within the device, such as OncoFreeze AI and FlowMotion AI, are designed to improve image quality, correct for motion, or automate planning. The performance metrics focus on the output of these features (e.g., changes in SUV, bed range identification accuracy, scatter correction accuracy) as part of the overall imaging system's functionality. Therefore, these features are evaluated in a standalone manner within the machine's operation, without explicit human-in-the-loop performance studies described here.

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

• NEMA NU2-2018 PET testing: Physical phantom with known activity concentrations and physical dimensions.
• OncoFreeze AI: Comparison to static images and Anzai-based gating, which implicitly serve as a reference or "ground truth" for the motion-corrected measurements.
• FlowMotion Multi-Parametric PET AI: Comparison to non-automated Patlak transformation results.
• FlowMotion AI (PET FAST Planning): Known or intended bed ranges from the configuration setup.
• QualityGuard: Measured time and staff exposure.
• Whole Body Scatter Correction: Known values from a "simulation study of phantom."

In summary, the ground truth types are primarily known physical properties of phantoms (or simulated phantoms), comparative measurements against established methods, or direct measurements of efficiency/safety.

8. The sample size for the training set:

The document does not provide any information about the training set size for the AI features (OncoFreeze AI, FlowMotion AI).

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

Since no information on training sets is provided, there is also no information on how ground truth for any training sets was established.

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The Siemens Biograph Horizon 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 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 Horizon 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 Horizon 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 Horizon 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 Bioqraph Horizon systems which is the subject of this application is substantially equivalent to the commercially available Biograph Horizon software. Modifications include:

• . Corrections to software anomalies and addition of new software features, including:
  • Continuous Bed Motion O
  • o HD·Chest (including Stitched HD Chest)
  • Whole Body Gating O
• HD FoV for Attenuation Correction о
• Phased Matched Gating O
• Low Dose CT Protocols for PET AC O
• SMART Mobile Connect O
• PET Dose Report O
• Enhanced IT Security O
• Scan Protocol Management o
• TeamViewer O
• Dual Topo O
• True Stack O

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

The provided text is a 510(k) Summary for the Siemens Biograph Horizon PET/CT system. It details the device, its intended use, and performance testing results. Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance

All performance testing met the predetermined acceptance values.

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

The document states that "PET Testing in accordance with NEMA NU2:2012 was conducted on two different configurations of the Biograph Horizon systems, a 3 ring version and a 4 ring version (TrueV)." NEMA NU2:2012 is a standard for the performance measurements of PET scanners, typically utilizing phantoms rather than human or clinical data. Therefore, the "test set" in this context refers to measurements taken on the physical systems using standardized phantoms. The document does not specify a separate sample size (e.g., number of patients or data points) beyond testing the two system configurations. The data provenance is derived from these physical system tests, not from a specific country of origin or clinical retrospective/prospective study.

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

Given that the performance testing was conducted according to NEMA NU2:2012, which involves standardized measurements using phantoms, the concept of "experts" establishing ground truth in a clinical sense (e.g., radiologists reviewing images) is not applicable here. The "ground truth" for this type of testing is established by the known physical properties and radioactive concentrations within the phantoms used, as measured against the NEMA standard.

4. Adjudication Method for the Test Set

As the performance testing against NEMA NU2:2012 involves direct physical measurements and calculations based on phantom acquisitions, there is no mention of a human adjudication method (like 2+1 or 3+1 consensus) in the document. The "Pass" results indicate that the measured values fell within the predefined acceptance ranges.

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

The provided document describes performance testing of a PET/CT scanner against technical standards (NEMA NU2:2012). It does not mention any multi-reader multi-case (MRMC) comparative effectiveness studies, nor any AI assistance to human readers. Therefore, no effect size for human reader improvement with/without AI can be determined from this document.

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

The document details the performance characteristics of the PET/CT hardware system. It refers to software modifications but these are for anomaly corrections and new features (e.g., Continuous Bed Motion, HD·Chest), not for an "algorithm only" standalone performance evaluation in a diagnostic context. The core performance testing focuses on the system's physical capabilities as measured by NEMA NU2:2012.

7. The Type of Ground Truth Used

The ground truth used for the performance testing was based on physical phantom measurements in accordance with the NEMA NU2:2012 standard. This standard defines precise methodologies for measuring metrics like resolution, sensitivity, and image quality using phantoms with known characteristics.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI. The testing performed is related to the physical performance of the PET/CT system hardware, not a data-driven model that would require a training set.

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

As no training set is mentioned in the context of the device's performance evaluation in this document, the method for establishing its "ground truth" is not applicable or described.

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The Siemens Biograph Horizon PET/CT systems and Biograph mCT and mCT Flow 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 Horizon PET/CT systems and Biograph mCT and mCT Flow 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 Horizon PET/CT systems and Biograph mCT and mCT Flow PET/CT 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.

The 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 Horizon PET/CT systems and Biograph mCT Flow PET/CT systems that are the subject of this Premarket Notification are identical in design, material, functionality, technology and energy source to the commercially available Biograph Horizon PET/CT systems and Biograph mCT and mCT Flow PET/CT systems.

The provided document describes a 510(k) Premarket Notification for Siemens Biograph Horizon PET/CT and Biograph mCT/mCT Flow PET/CT Systems. The purpose of this submission is not to introduce a new device, but to support an additional indication for use for low dose lung cancer screening in high-risk populations. The key information for this request revolves around demonstrating that the CT component of these combined PET/CT systems is substantially equivalent to standalone SOMATOM CT systems (K142955) that already have this specific indication.

Therefore, the "proof" is based on demonstrating equivalence to an already cleared device, rather than a de novo clinical study proving effectiveness or a multi-reader, multi-case study in the context of AI assistance. The document explicitly states: "No additional performance testing beyond what was cleared in the original Premarket Notifications is required." This means that the original performance tests for the standalone CT systems are being leveraged.

Below is an attempt to structure the information based on your request, noting that some of your specific categories (like AI assistance, ground truth for training sets, number of experts for ground truth, and adjudication methods for a novel device) are not directly applicable to this specific 510(k) submission due to its nature as an "additional indication for use" based on substantial equivalence.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate)

The acceptance criteria for the new indication for use (low dose lung cancer screening) are based on demonstrating that the performance of the CT component within the Biograph Horizon PET/CT and Biograph mCT/mCT Flow PET/CT Systems is identical to that of the previously cleared standalone SOMATOM CT systems (K142955) for this specific application.

1. Table of Acceptance Criteria and Reported Device Performance:

Conclusion from performance testing: "The test results demonstrate that the subject devices perform the same as the standalone SOMATOM CT systems. Since the standalone systems have been identified as suitable for lung cancer screening (K142955), the use of the CT component of the Biograph Horizon PET/CT systems and Biograph mCT and mCT Flow PET/CT systems is likewise suitable for lung cancer screening."

Study Details Proving Device Meets Acceptance Criteria

This submission relies on demonstrating substantial equivalence to existing, legally marketed predicate devices, specifically the standalone SOMATOM CT systems (K142955) that were previously cleared for low dose lung cancer screening. Therefore, the "study" is primarily a comparative analysis of technical parameters and design specifications, rather than a new clinical trial.

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

• Test Set Sample Size: Not applicable in the context of patient data for this specific 510(k). The "test set" here refers to the technical parameters of the devices.
• Data Provenance: The comparison is made between the technical specifications and existing performance validation (from previous 510(k) clearances) of the Biograph Horizon/mCT/mCT Flow PET/CT systems and the SOMATOM CT systems (K142955). This is an engineering and regulatory comparison of device characteristics and previously validated performance, not a new retrospective or prospective clinical data study.

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

• Not directly applicable. The "ground truth" for this submission is whether the technical parameters of the CT component in the PET/CT system are demonstrably identical to those of the predicate standalone CT system. This is established through engineering specifications, previous performance reports, and adherence to recognized standards, rather than expert consensus on a scan dataset for a new device. The original clearance for the predicate CT system would have involved relevant expert input.

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

• Not applicable. This is not a study involving human reader interpretation of images that would require an adjudication method.

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 versus without AI assistance:

• No MRMC study was conducted for this 510(k) submission. The device (PET/CT system) is an imaging equipment; it is neither an AI algorithm nor an AI-assisted diagnostic tool in the sense of the question. The request is to add an indication for a human-interpreted CT scan for screening.

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

• The CT component itself is a standalone imaging modality within the PET/CT system. The "performance" assessment was of these physics/engineering parameters to ensure they are identical to the predicate CT system. There is no AI algorithm being evaluated for standalone performance in this submission.

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

• For this specific submission, the "ground truth" is the proven performance and technical specifications of the predicate device (SOMATOM CT systems K142955) regarding its suitability for low dose lung cancer screening. The comparison aims to establish that the subject device's CT component matches these established characteristics.
• The basis for the predicate device's clearance for lung cancer screening likely involved referencing clinical literature, such as the National Lung Screening Trial (NLST), and guidelines from professional medical societies, which would implicitly rely on outcomes data and expert consensus for defining suitable screening parameters and populations.

8. The sample size for the training set:

• Not applicable. This submission is for an imaging device, not an AI algorithm requiring a training set.

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

• Not applicable (as above).

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The Siemens Biograph Horizon PET/CT systems are combined 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.

The Biograph Horizon PET/CT system is a 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 Horizon scanners 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 Horizon 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 provided document is a 510(k) summary for the Biograph Horizon PET/CT system. It details the device, its intended use, and performance testing, primarily focusing on its substantial equivalence to a predicate device. However, it does not contain the specific information required to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria for image interpretation by an AI algorithm.

The performance testing described is for the physical performance of the PET and CT components of the hardware, not for an AI algorithm's ability to detect, localize, diagnose, or stage lesions, tumors, disease, or organ function. The study referenced is a hardware performance test according to NEMA NU2:2012 for PET and FDA Performance Standards for ionizing radiation emitting products for CT.

Therefore, I can only populate parts of your request based on the provided text, and many sections will be "Not Applicable" or "Not Provided" due to the nature of the document being a hardware 510(k) rather than an AI/software 510(k).

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a table of performance criteria and results for the PET component based on NEMA NU2:2012. These are for the physical characteristics of the scanner, not the performance of an AI algorithm interpreting images.

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