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The Siemens SOMATOM Definition Edge, SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of xray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

The Siemens SOMATOM Definition AS/AS* and SOMATOM Definition Edge equipped with syngo CT VA48 are Computed Tomography X- ray Systems. which feature a continuously rotating tube-detector system and functions according to the fan beam principle. The SOMATOM Definition AS/ AS* and SOMATOM Definition Edge produce CT images in DICOM format, which can be used by post-processing applications commercially distributed by Siemens and other vendors.

The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The version of system software, syngo CT VA48, supports functionality such as Twin Beam scanning, Fast 3D Align, TrueD 4D Viewer, Fast DE evaluation and improved functionality with extended Field of View. The computer system delivered with the CT scanner is able to run optional post processing applications.

In addition to the previously supported software functionality, which was cleared for the FAST DE Result evaluation of Dual Source and Single Source (dual spiral) data, the subject device will support the FAST DE Result evaluation of data acquired with TwinBeam technology. FAST DE Results evaluation allows to use the optional post-processing features Monoenergetic Plus and Virtual Enhanced.

The Siemens SOMATOM Definition AS/AS+ and SOMATOM Definition Edge (with software version syngo CT VA48) is a Computed Tomography X-ray System. Its primary function is to produce cross-sectional images of the body by computer reconstruction of x-ray transmissions data. The device was evaluated to demonstrate continued conformance with special controls for medical devices containing software.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not explicitly stated as a number of cases/patients. The document mentions "retrospective analysis of available patient data" and "supportive articles that demonstrate the usability," but does not provide a specific numerical sample size for this patient data.
• Data Provenance: The document states "retrospective analysis of available patient data." The country of origin for the data is not specified.

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

• This information is not provided in the document. The document mentions "supportive articles that demonstrate the usability," which might imply expert review, but no details are given about the number or qualifications of experts for establishing ground truth on the test set.

4. Adjudication Method for the Test Set:

• This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done with human readers comparing performance with and without AI assistance. The study focuses on the device's technical performance and its equivalence to predicate devices, not on human reader improvement with AI.

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

• Yes, a standalone performance assessment was conducted for the device's software functionalities. The performance tests ("Phantom bench testing and retrospective analysis of available patient data was conducted for application classes Monoenergetic Plus and Virtual Unenhanced for the FAST DE Results for TwinBeam Data software module") evaluate the algorithm's output directly.

7. The Type of Ground Truth Used:

• The document mentions "phantom bench testing" and "retrospective analysis of available patient data." For phantom testing, the ground truth would be the known properties of the phantom. For retrospective patient data, the type of ground truth is not explicitly stated (e.g., expert consensus on original scans, pathology). However, the context of "supportive articles that demonstrate the usability" suggests comparison against accepted clinical interpretation or existing diagnostic standards, rather than pathology or long-term outcomes data primarily.

8. The Sample Size for the Training Set:

• The document does not specify a sample size for a training set. The descriptions focus on verification and validation testing, and on demonstrating functionality and equivalence. "Available patient data" is mentioned in the context of retrospective analysis for performance testing, not explicitly for training.

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

• As a training set is not explicitly mentioned and described, information on how its ground truth was established is not provided. The device in this submission is an update to a CT system's software functionality (specifically "FAST DE Results for TwinBeam Data"), rather than a new AI/CADx algorithm that requires extensive new training data in the context of this 510(k) summary. The focus is on demonstrating that the new software version performs as intended and is substantially equivalent to previous versions.

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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 and mCT Flow PET/CT Scanners 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:

• Syngo software upgrade
• Somaris Software (cleared in K143400, K143401))
• Twin beam scanning feature for Biograph mCT-X and Biograph mCT Edge
• HD Field of View Pro
• Iterative Metal Artifact Reduction (iMAR)
• Temporal minimum intensity projection and temporal maximum intensity projections (tMIP)
• FAST 3D align / 3D Reconstruction
• FAST DE Results
• Repiratory Online mode
• Enhancements to the Iterative Reconstruction software (ADMIRE)
• PETsyngo software

Here's an analysis of the provided text regarding the acceptance criteria and study for the Biograph mCT and mCT Flow PET/CT Scanners, based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a table summarizing performance criteria and results based on NEMA NU2:2012 testing for the PET subsystem.

= 9.4 cps/kBq (4R) |
| Count Rate peak NECR | Pass | >= 95 kcps @ 30 kBq/cc (3R)
= 165 kcps @ 28 kBq/cc (4R) |
| Count Rate peak trues | Pass | >= 350 kcps @ 46 kBq/cc (3R)
= 575 kcps @ 40 kBq/cc (4R) |
| Count Rate bias (mean) | Pass |

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