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Siemens mCT 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 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 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. (High risk population has been 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 mCT family 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 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 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 mCT systems which is the subject of this application is substantially equivalent to the commercially available Biograph mCT software. Modifications include:

• Somaris Software (cleared in K152036)
  • o Upgrade to the latest revision of Somaris Software
• PETsyngo software ●
  • Update of the software to add Low CT Does Protocols for PET AC O
  • Update to add Wholebody Scatter Correction O
  • QualityGuard O
  • FlowMotion Multi-Parametric PET O
  • O OncoFreeze
  • o CardioFreeze
  • Shuttle Mode PET Acquisition o
  • Parallel Reconstruction O
  • PET Dose Report O
  • TeamViewer O
  • Maximum Patient Clearance Mode o
  • Smart Mobile Connect o
  • O Update of the software corrections
  • Update of the TrueD software component O
    • Address anomalies
    • Update to improve usability and viewing of Multi-Parametric PET imaqes
  • Improvements to workflow o
  • Improvements to performance (faster reconstruction speeds) о

This document describes the performance testing for the Siemens Biograph mCT and mCT Flow PET/CT Scanners (K173578). This is not an AI/ML device, therefore, some of the requested information (e.g., training set, expert adjudication, MRMC study, standalone performance) is not applicable.

1. Table of Acceptance Criteria and Reported Device Performance:

The performance testing was conducted in accordance with NEMA NU2:2012. The following table summarizes the acceptance criteria and the "Pass" results reported for two different configurations (3-ring and 4-ring versions) of the Biograph mCT systems.

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

The document states that performance testing was conducted on two different configurations of the Biograph mCT systems: a 3-ring version and a 4-ring version. The testing was performed in accordance with NEMA NU2:2012, which typically involves standardized phantom studies rather than patient data. Therefore, the "sample size" refers to the number of phantom configurations tested. The data provenance is laboratory-based phantom testing, not patient data from a specific country or retrospective/prospective study.

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 as the performance testing for a PET/CT scanner, according to NEMA NU2:2012 standards, relies on objective measurements from physical phantoms rather than human expert interpretation or ground truth establishment in a clinical context.

4. Adjudication method for the test set:

This information is not applicable as the performance testing for a PET/CT scanner, according to NEMA NU2:2012 standards, relies on objective measurements from physical phantoms rather than human expert interpretation or adjudication.

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:

This is not applicable. The device is a PET/CT scanner, a medical imaging hardware system, not an AI-powered diagnostic algorithm.

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

This is not applicable. The device is a PET/CT scanner, a hardware system with integrated software, not a standalone algorithm. Performance is assessed through physical measurements, not algorithmic output on its own.

7. The type of ground truth used:

The ground truth for this type of device is established by the physical properties of the phantoms used in the NEMA NU2:2012 testing. These phantoms have known dimensions, radioactive concentrations, and other physical characteristics that serve as the "true" values against which the scanner's measurements are compared.

8. The sample size for the training set:

This is not applicable. The device is a PET/CT scanner, which is a medical imaging hardware system. It does not employ machine learning that requires a "training set" in the conventional AI sense.

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

This is not applicable for the same reasons as #8.

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The Siemens Biograph mCT 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.

The Biograph mCT family 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 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 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 updates to the Biograph mCT systems which are the subject of this application are considered substantially equivalent to the commercially available Biograph mCT software. Major modifications to the family of systems include:

• Updated 510(k) cleared CT. is used compared to the CT used in the predicate PET/CT system . (K113448);
• · Updated gantry control buttons, and patient call button;
• Updated computer hardware;
• Updated software including:
  • updated operating system; 0
  • additional user configurable options and workflows
  • cardiac gating updates to provide for improved gating characteristics :; o
  • updated workflows for ease of use; and ಂ
  • improvements in image quality. o

The new Biograph mCT capitalizes on list mode acquisition and positional information. Combined with the latest generation computer electronics it enables to continually take counts and reconstruct image data, providing a real-time display of the data flow as reconstructed.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Biograph mCT Family of PET/CT Systems:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states: "PET Testing in accordance with NEMA NU2.2007 was conducted on two different configurations of the Biograph mCT systems, a 3 ring version and a 4 ring version."

• Sample Size for Test Set: The sample size is not explicitly stated in terms of number of cases or patients. Instead, the testing was performed on two physical configurations of the device (a 3-ring and a 4-ring version). NEMA NU2.2007 is a standard for and performance measurements of PET scanners, implying testing on phantoms or standardized objects rather than patient data.
• Data Provenance: The document does not specify country of origin for data. Given it's a Siemens Medical Solutions USA, Inc. submission, the testing would likely have taken place in the US or at Siemens facilities. The testing appears to be prospective in nature, as it's a conformity assessment against a standard for a new or updated device.

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

This document describes a technical performance testing of a PET/CT scanner against established engineering and physics standards (NEMA NU2.2007). It does not involve clinical studies with human image interpretation or diagnostic accuracy assessment. Therefore, the concept of "experts used to establish ground truth for the test set" in the context of clinical interpretation is not applicable to this submission. The "ground truth" here is derived from objective physical measurements and comparisons to NEMA standards.

4. Adjudication Method for the Test Set

As this is technical performance testing against a standard and not a clinical study involving human interpretation, an adjudication method in the typical sense (e.g., 2+1, 3+1 for clinical consensus) is not applicable. The "adjudication" is inherent in the objective measurement and comparison to the NEMA NU2.2007 standard. If a measurement falls within the specified range (e.g., <= 6.5 mm for resolution), it "Passes."

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

No. The document does not describe an MRMC comparative effectiveness study comparing human readers with and without AI assistance. This submission focuses on the technical performance specifications of the PET/CT hardware and updated software.

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

Yes, in a way. The "Performance Testing" section describes the device's technical performance in a standalone context, as objectively measured against NEMA NU2.2007 standards. The results (e.g., resolution, sensitivity, count rate) are measures of the algorithm and hardware's intrinsic performance, independent of a human operator's diagnostic interpretation.

7. Type of Ground Truth Used

The ground truth used for this performance testing is based on objective physical measurements against an established industry standard: NEMA NU2.2007. This standard defines precise methods and acceptable ranges for various performance metrics of PET scanners. It is not expert consensus, pathology, or outcomes data, but rather a technical benchmark.

8. Sample Size for the Training Set

The document does not mention a training set in the context of machine learning or AI. This submission is for an updated PET/CT system, and the "updated software" mentioned (including "improvements in image quality") are likely traditional image processing algorithms rather than deep learning models requiring large training datasets. Therefore, a "training set" as commonly understood in AI/ML is not applicable here.

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

Since no training set for AI/ML is mentioned, the method for establishing its ground truth is not applicable.

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The Siemens Biograph mCT 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.

The Biograph mCT systems are combined multi-slice X-Ray Computed Tomoqraphy and Positron Emission Tomography scanners. These systems are designed for whole body oncology, neurology and cardiology examinations. The 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 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 mCT systems which is the subject of this application is substantially equivalent to the commercially available Biograph mCT software. Modifications include:

• . Improvements to Radiation Dose Monitoring
• . Radiation Dose Reduction Initiatives
• Image Quality improvements .
• . Workflow Enhancements

The provided document does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or information on sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML context. This submission is for modifications to a combined PET/CT system, focusing on improvements to existing functionalities rather than the introduction of new AI-driven diagnostic capabilities.

The document discusses general safety and effectiveness through risk management (ISO 14971:2007) and adherence to industry standards (IEC 60601-1 series, 21 CFR 1020.30, 21 CFR 1020.33), along with verification and validation of systems according to documented procedures. However, it does not provide quantitative acceptance criteria or a specific study designed to "prove" the device meets such criteria in terms of diagnostic performance metrics like sensitivity or specificity.

The modifications mentioned are:

• Improvements to Radiation Dose Monitoring
• Radiation Dose Reduction Initiatives
• Image Quality improvements
• Workflow Enhancements

These improvements are intended to maintain or enhance the already established performance of the Biograph mCT systems. The submission asserts "no changes implemented... impact either the fundamental technology or the indications for use" and that the modified device is "substantially equivalent to the currently commercially available predicate device." This indicates that the primary assessment for this 510(k) was based on demonstrating equivalence and maintaining safety and performance, rather than providing new performance studies with specific acceptance criteria that would typically be seen for a novel diagnostic algorithm.

Therefore, I cannot provide the requested information for acceptance criteria, device performance tables, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, or ground truth specifics, as these are not present in the provided text.

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

• Additional configuration license options
• Improvement of performance characteristics of the PET and CT, and
• Optimization of workflows

This 510(k) premarket notification describes modifications to the Siemens Biograph mCT systems. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (K081453) rather than presenting a performance study with acceptance criteria for a new device's clinical efficacy regarding a specific diagnostic task.

Therefore, the document does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance related to a specific diagnostic task or a clinical study proving new performance claims. The modifications are described as:

• Additional configuration license options
• Improvement of performance characteristics of the PET and CT
• Optimization of workflows

These are technical modifications and workflow improvements, not changes that require a new clinical trial to establish diagnostic performance against specific metrics like sensitivity or specificity for a disease. The safety and effectiveness section refers to risk management and compliance with industry standards, not a clinical performance study.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and the Reported Device Performance:

• Acceptance Criteria: Not specified in terms of clinical diagnostic performance (e.g., sensitivity, specificity, accuracy for detecting a specific condition). The notification focuses on technical equivalence and compliance with safety standards (e.g., ISO 14971, IEC 60601-1, 21 CFR 1020.30, 21 CFR 1020.33).
• Reported Device Performance: No specific performance metrics (like accuracy, sensitivity, specificity, or lesion detection rates) are reported in the context of a new study proving these modifications meet specific clinical acceptance criteria. The document states "Improvement of performance characteristics of the PET and CT," but does not quantify these improvements or link them to clinical acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Not Applicable. The document does not describe a clinical performance study with a test set of patient data.

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

• Not Applicable. No clinical performance study is described.

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

• Not Applicable. No clinical performance study is described.

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

• Not Applicable. This is a clearance for modifications to a PET/CT scanner, not an AI-assisted diagnostic device, and no MRMC study is described.

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

• Not Applicable. Not an algorithm-only device in the context of a new diagnostic claim.

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

• Not Applicable. No clinical performance study is described.

8. The sample size for the training set:

• Not Applicable. No machine learning or AI model training is described for new diagnostic claims. The "improvements" are likely engineering changes and software optimizations, not AI model updates.

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

• Not Applicable. No machine learning or AI model training is described.

Summary of Document Focus:

This 510(k) is for modifications to an existing device (Biograph mCT systems) to demonstrate substantial equivalence to a previously cleared predicate device (K081453). The modifications primarily relate to:

• Technical/System Improvements: "Improvement of performance characteristics of the PET and CT" and "Optimization of workflows."
• Software Enhancements: "Additional configuration license options."

The safety and effectiveness section refers to compliance with risk management (ISO 14971) and electrical/radiation safety standards (IEC 60601-1 series, 21 CFR 1020.30, 21 CFR 1020.33), which are typical for hardware and software modifications in imaging devices. It does not outline new clinical performance studies to prove quantitative improvements in diagnostic accuracy for specific conditions. The "Indications for Use" remain broad, covering general diagnostic purposes of PET/CT.

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