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The Siemens 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 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.

Biograph Trinion 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. Biograph Trinion 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.

Biograph Trinion VK20 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.

Biograph PET/CT systems, which are the subject of this application, are substantially equivalent to the commercially available Biograph Trinion VK10 family of PET/CT systems (K233677). Differences compared to the commercially available Biograph Trinion systems include:

• The commercially available SOMATOM go.All and go.Top systems with VB10 (K233650) software have been incorporated into the Biograph Trinion VK20 systems, including commercially available CT features.

• Additional PET axial field of view (FoV) systems allowing for more scalability.

• Additional patient communication and comfort features.

• PET respiratory gating with an external gating device has been implemented.

The Biograph Trinion models may also use the names Biograph Mission, Biograph Wonder, Biograph Ambition and Biograph Devotion for marketing purposes.

The provided FDA 510(k) clearance letter for the Biograph Trinion PET/CT system primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to recognized performance standards. It indicates that "all performance testing met the predetermined acceptance values," but does not provide specific numerical acceptance criteria or reported device performance for an AI/algorithm component, nor does it detail a study proving the device meets AI-specific acceptance criteria. The context suggests the "performance testing" refers to general PET/CT system performance, not AI-driven diagnostic assistance.

Therefore, many of the requested details, particularly those related to a standalone AI algorithm's performance, human-in-the-loop studies, dataset characteristics (sample size, provenance), and ground truth establishment methods for an AI component, are not available in the provided text.

Based on the information available in the document, here's what can be extracted and inferred, with explicit notes where information is missing or not applicable in the context of an AI study.

Acceptance Criteria and Reported Device Performance

The document states that "all performance testing met the predetermined acceptance values." However, it does not specify what those acceptance values were or the precise reported performance metrics beyond this general statement. The tests conducted were primarily related to the physical performance of the PET/CT system as per NEMA NU 2:2024 and NEMA XR 25:2019 standards, not specifically an AI component for diagnostic aid.

Table of Acceptance Criteria and Reported Device Performance (Based on available information for the PET/CT system):

Study Details (Focusing on AI-related aspects where applicable, and general system testing otherwise)

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

   • For System Performance (NEMA tests): The document does not specify a "test set" in terms of patient data. NEMA tests typically involve phantom studies rather than patient data. Thus, sample size and data provenance are not applicable in the traditional sense for these tests.
   • For AI Component: The document does not provide any information on a test set (patient cases, images) or data provenance (e.g., country of origin, retrospective/prospective) for validating an AI component for diagnostic assistance. The descriptions are entirely about the physical PET/CT system.

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

   • For System Performance: Ground truth for NEMA tests is established by physical measurements and calibration standards, not human experts.
   • For AI Component: This information is not provided in the document as there's no mention of an AI-driven diagnostic aid requiring expert-established ground truth.

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

   • For System Performance: Not applicable.
   • For AI Component: This information is not provided in the document.

4. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • The document does not indicate that an MRMC study was performed for an AI component. The focus is on the substantial equivalence of the PET/CT hardware and software to a predicate device, and compliance with performance standards for the imaging system itself.

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

   • The document does not detail any standalone algorithm performance testing. The performance testing described is for the integrated PET/CT system's physical and functional characteristics.

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

   • For System Performance: Ground truth for NEMA tests involves physical phantoms and established measurement protocols.
   • For AI Component: This information is not provided in the document.

7. The sample size for the training set:

   • This information is not provided in the document, as there is no mention of an AI model that undergoes a separate training process requiring a distinct training set.

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

   • This information is not provided in the document, as there is no mention of an AI model's training set.

Summary of Device and Performance Information from Document:

The provided 510(k) clearance letter for the Biograph Trinion is for a PET/CT imaging system, not an AI-based diagnostic software. The "performance testing" described in the document pertains to the physical and functional aspects of the PET/CT scanner (e.g., spatial resolution, sensitivity, image quality) as measured against industry standards (NEMA NU 2:2024). The clearance is based on proving substantial equivalence to a predicate device and adherence to these well-established performance standards for imaging hardware.

Therefore, the detailed questions regarding AI acceptance criteria, AI test set characteristics, human-in-the-loop studies, and AI ground truth establishment are not addressed in this document because the device being cleared is the imaging system itself, not an AI software component for image analysis or diagnostic support. The document implies that the system can be used for certain clinical applications (like lung cancer screening), but it doesn't describe an automated AI system within the device that requires separate clinical validation with reader studies or large patient datasets.

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This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations*.

• As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Siemens intends to market a new Single source CT system NAEOTOM Alpha.Prime and a new Dual Source CT system NAEOTOM Alpha.Pro based on the SOMARIS/10 software platform.

Siemens also intends to market updated software version, SOMARIS/10 syngo CT VB20, for the new NAEOTOM CT scanner systems and for the NAEOTOM Alpha cleared in K233657 (clearance date March 28th, 2024). The updated software version SOMARIS/10 syngo CT VB20 incorporates mainly features for radiotherapy planning support.

With the new software version SOMARIS/10 syngo CT VB20, the trade name of NAEOTOM Alpha cleared in K233657 has been changed to NAEOTOM Alpha.Peak for ex-factory systems. Systems already installed will receive the software update without change of the trade name. The system label keeps the product name NAEOTOM Alpha. System label information and UDI are not changed and remain the same as the original submitted.

For simplicity, the product name of NAEOTOM Alpha will be used throughout this submission instead of the trade name NAEOTOM Alpha.Peak.

The subject devices NAEOTOM Alpha (trade name ex-factory CT systems: NAEOTOM Alpha.Peak) and NAEOTOM Alpha.Pro with software version SOMARIS/10 syngo CT VB20 are Computed Tomography X-ray systems which feature two continuously rotating tube-detector systems, denominated as Aand B-systems respectively (dual source NAEOTOM CT scanner system).

The subject device NAEOTOM Alpha.Prime with software version SOMARIS/10 syngo CT VB20 is a Computed Tomography X-ray system which features one continuously rotating tube-detector systems, denominated as A-system (single source NAEOTOM Alpha CT scanner system).

The detectors' function is based on photon-counting technology.

In this submission, the above-mentioned CT scanner systems are jointly referred to as subject devices by "NAEOTOM CT scanner systems".

The NAEOTOM CT scanner systems with SOMARIS/10 syngo CT VB20 produce CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens and other vendors. The CT images can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions. The radiation therapy planning support includes, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery. The computer system delivered with the CT scanner is able to run optional post-processing applications.

Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists, or technologists. The user must have the necessary U.S. qualifications in order to diagnose or treat the patient with the use of the images delivered by the system.

The platform software for the NAEOTOM CT scanner systems is syngo CT VB20 (SOMARIS/10 syngo CT VB20). It is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The software platform provides plugin software interfaces that allow for the use of specific commercially available post-processing software algorithms in an unmodified form from the cleared stand-alone post-processing version.

Software version syngo CT VB20 (SOMARIS/10 syngo CT VB20) is a modified software version of the primary predicate device NAEOTOM Alpha, syngo CT VB10 (SOMARIS/10 syngo CT VB10) cleared in K233657.

Software version SOMARIS/10 syngo CT VB20 will be offered ex-factory and as optional upgrade for the existing NAEOTOM Alpha systems.

The bundle approach is feasible for this submission since the subject devices have similar technological characteristics, software operating platform, and supported software characteristics. All subject devices will support previously cleared software and hardware features in addition to the applicable modifications as described within this submission. The intended use remains unchanged compared to the predicate devices.

The provided document is a 510(k) summary for the Siemens NAEOTOM CT Scanner Systems, specifically addressing the updated software version SOMARIS/10 syngo CT VB20 and new system configurations (NAEOTOM Alpha.Pro and NAEOTOM Alpha.Prime).

The document does not contain a multi-reader, multi-case (MRMC) comparative effectiveness study with human readers improving with AI vs. without AI assistance. The device described is a Computed Tomography (CT) X-ray system, which is a medical imaging hardware device, not an AI software intended for image interpretation assistance to human readers in the way an MRMC study would typically evaluate. The software features described primarily relate to system control, image reconstruction, and workflow efficiency, some of which are automated ("FAST" technologies) but do not indicate an "AI assistance" that augments a human reader's diagnostic performance in a comparative study design. Therefore, the questions related to MRMC studies and human reader improvement are not applicable to the information provided in this 510(k) summary.

Additionally, the document describes non-clinical performance testing (bench testing), which evaluates the technical performance of the device and its features, rather than a clinical study evaluating diagnostic accuracy against a ground truth from expert readers or pathology. The performance data presented is based on phantom tests and technical assessments rather than a clinical study. Therefore, several of the requested elements (number of experts, adjudication methods, type of ground truth for test sets/training sets, sample sizes for training/test sets as they pertain to clinical data) are not directly addressed in the context of a clinical performance study as typically understood for AI/CADe devices.

The acceptance criteria and reported device performance are generally stated in terms of comparable or improved accuracy to predicate devices and successful completion of verification and validation testing against internal specifications and recognized standards.

Here's an attempt to answer the questions based on the provided document, noting the limitations regarding the type of device and performance data presented:

Acceptance Criteria and Device Performance Study Summary

The device in question is a Computed Tomography (CT) X-ray System (NAEOTOM CT Scanner Systems) with software version SOMARIS/10 syngo CT VB20. The performance data provided are primarily from non-clinical bench testing to demonstrate the device's technical capabilities and comparability to predicate devices. The focus is on functionality verification and image quality evaluation, particularly for new and modified features.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific, quantifiable table of "acceptance criteria" for features in the typical sense of a clinical trial (e.g., sensitivity/specificity thresholds). Instead, "acceptance criteria" are referenced as being "related to the corresponding requirements" for various verification and validation tests. The reported performance is generally qualitative, stating that features meet expectations or are comparable/improved to predicate devices.

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

The "test set" in this context refers to phantom test data used for non-clinical bench testing.

• Sample Size: Not explicitly quantified as a number of "cases" or "patients" in the way a clinical study would. The descriptions indicate testing was performed on "a dynamic phantom" for Direct i4D, and "additional data from adults and adolescence patients" for FAST 3D Camera accuracy (though this data was for optimizing the feature, not for an independent test set as typically understood for a clinical performance evaluation). For FAST Planning, testing was done on "patient data" but no sample size is given. For Low-Dose Lung Cancer Screening, "technical parameters" were compared, implying phantom or engineering data. The overall testing framework includes "System Validation test" and "System Verification test" with various activities, but no specific human subject test set is detailed.
• Data Provenance: The data is from non-clinical bench testing and internal verification/validation activities. There is no mention of data origin in terms of "country of origin" as it is not a clinical study involving patient data from specific geographical locations. The testing is described as part of product development, implying internal company testing. It is inherently retrospective in the sense that it's testing a developed product against its specifications.

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

This information is not provided as the performance data is from non-clinical bench testing, not from a clinical study with a ground truth established by medical experts interpreting images. The "ground truth" for these tests would be the pre-defined technical specifications and expected physical behavior of the system, verified by engineering and quality assurance personnel.

4. Adjudication Method for the Test Set

Since there is no clinical test set involving human expert interpretations and potential discrepancies, an "adjudication method" is not applicable. The "acceptance criteria" for the non-clinical tests are against internal requirements and performance metrics (e.g., accuracy against a known phantom truth, successful triggering of functions).

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

No, an MRMC comparative effectiveness study was not done according to the provided information. This submission is for a CT scanner system (hardware and associated control/reconstruction software), not an AI software intended to assist human readers in image interpretation. The performance data focuses on the technical capabilities of the CT system itself.

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

The "performance data" section describes the technical performance and functionality of various software and hardware features, which can be considered "standalone" in the sense of evaluating the algorithm/system's output against a known input (e.g., phantom data). For instance:

• Direct i4D: Performance evaluated based on data acquisition and artifact avoidance.
• FAST Planning: Assessed the algorithm's ability to calculate ranges correctly and its speed.
• Low-Dose Lung Cancer Screening: Compared technical parameters.

However, this is not a "standalone performance" measure for diagnostic accuracy of an AI algorithm in the context of interpreting medical images compared to a clinical ground truth, but rather the technical performance of the imaging device and its embedded functionalities.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" is technical/physical ground truth based on phantom properties, defined test conditions, and engineering specifications. For instance:

• For Direct i4D, the ground truth is the "breathing pattern of a thorax phantom."
• For FAST 3D Camera, the ground truth for accuracy would be the known physical position/orientation relative to the scanner.
• For FAST Planning, the ground truth involves "correct" calculated ranges based on anatomical rules or system design.

There is no mention of ground truth established via expert consensus, pathology, or outcomes data, as these are non-clinical hardware/software performance tests.

8. The Sample Size for the Training Set

The document does not provide information on a "training set" in the context of machine learning or AI models with labelled clinical data. The software features described are primarily rule-based or optimized algorithms, not deep learning models that require large labelled training datasets. While some features like FAST 3D camera were "optimized using additional data," this refers to data used for algorithm refinement (development/internal testing) and not a distinct "training set" for an AI model that would then be tested on an independent "test set."

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

Since no explicit "training set" for AI/ML algorithms is described in the provided context, this question is not applicable. The development and optimization of the system's features rely on engineering specifications, physical models, and potentially iterative refinement using internal test data (phantoms, potentially anonymized patient data for feature optimization) where the "truth" is either known by design or derived from highly controlled measurements.

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The Symbia Pro.specta systems are intended for use 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 or additional uses. SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques: planar imaging, whole body imaging, and tomographic imaging for isotopes with energies up to 588 keV.

CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes taken at different angles.

SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images. The SPECT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images.

Software: The SPECTsyngo software is an acquisition, display and analysis package intended to aid the clinician in the assessment and quantification of pathologies in images produced from SPECT, PET. CT. and other imaging modalities.

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.

There are no known contraindications.

The Siemens Symbia Pro.specta VA30A Family consists of Single-Photon Emission Computed Tomography (SPECT) scanner and integrated hybrid x-ray Computed Tomography (CT) and SPECT scanner.

The SPECT subsystem images and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and integrates CT's anatomical detail for precise reference of the location of the metabolic activity.

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 system can be used as an integrated SPECT and CT modality while also enabling independent functionality of SPECT and CT as stand-alone diagnostic imaging devices.

Siemens Symbia Pro.specta VA30A Family maintains the same intended use and indications for use as the commercially available Symbia Pro.specta VA20A family (K231102).

Symbia Pro.specta VA30A Family are hybrid modality imaging systems comprised of two separate but integrated components: a gamma camera (SPECT) and a CT. The gamma camera is based on hardware and software features that generate nuclear medicine images based on the uptake of radioisotope tracers in a patient's body. The CT system (spiral CT) is designed to produce 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 combination of SPECT and CT in a single device has several benefits. The SPECT subsystem images biochemical function while the CT subsystem images anatomy. The combination enables scans that not only indicate function, e.g., how active a tumor is, but precise localization, e.g., the precise location of that tumor in the body.

In addition, CT can be used to correct for the attenuation in SPECT acquisitions. Attenuation in SPECT is an unwanted side effect of the gamma rays scattering and being absorbed by tissue. This can lead to errors in the final image. The CT directly measures attenuation and can be used to create a 3D attenuation map of the patient which can be used to correct the SPECT images. The SPECT-CT scanner can be used to image and track how much dose was delivered to both the target and the surrounding tissue.

The systems consist of display equipment, data storage devices, patient and equipment supports and component parts and accessories.

Symbia Pro.specta VA30A release is the product name for the addition of features to the approved Symbia Pro.specta VA20A Family (K231102). The Symbia Pro.specta VA30A devices are based on the Symbia Pro.specta VA20A Family. The difference lies in the additional features/changes. The Intended Purpose and fundamental scientific technology remain unchanged.

Proposed new features in Symbia Pro.specta VA30 include:

• Cardiac Quantification
• High Speed Mode
• . NM Remote Reconstruction on myExam Satellite

Other changes:

• Scanning improvements
• Recon improvements ●
• General software improvements ●
• Miscellaneous improvements ●

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets them. The document primarily describes the device, its intended use, and its equivalence to a predicate device, as well as a list of performance tests and standards it complies with. It does not provide specific acceptance criteria values or detailed study results with sample sizes, expert qualifications, or adjudication methods for studies proving the device meets those criteria.

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