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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.

Note: The "Reported Device Performance" column indicates "Pass" for all criteria, implying that the quantitative results met or exceeded the specified acceptance values. The document does not provide the exact numerical performance values here, only that they passed.

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

• Sample Size: The document mentions that "PET Testing in accordance with NEMA NU2:2012 was conducted on two different configurations of the Biograph mCT systems, a 3 ring version and a 4 ring version." NEMA NU2 standards typically involve testing on phantom devices, not human patient data. Therefore, the "sample size" refers to the specific configurations of the physical device that were subjected to the NEMA tests. There is no mention of a "test set" in terms of patient data.
• Data Provenance: The testing is described as being conducted on physical devices (3-ring and 4-ring versions of Biograph mCT systems). There is no mention of country of origin for the data or whether it was retrospective or prospective, as it's not a study based on patient data in this context.

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

Not applicable. The performance testing described is based on engineering and physics measurements using phantoms according to the NEMA NU2:2012 standard, not on human interpretation or ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable, as the testing involves objective physical measurements against a standard (NEMA NU2:2012), not subjective assessment requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes technical performance testing of the PET/CT scanner against an industry standard (NEMA NU2:2012), not a comparative effectiveness study involving human readers with or without AI assistance. The modifications listed are software upgrades and feature additions to the existing device, not an AI component intended to improve human reader performance in diagnostically significant ways requiring an MRMC study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, in a way. The performance testing against NEMA NU2:2012 is a standalone evaluation of the device's physical and technical performance parameters (e.g., resolution, sensitivity, count rates) as an imaging system, independent of human interpretation of images. The device itself (the PET/CT scanner) is the "algorithm" or system being tested in this context for its fundamental imaging capabilities.

7. The Type of Ground Truth Used

The ground truth used for these performance tests is defined by the NEMA NU2:2012 standard. This standard specifies phantoms (precisely engineered physical objects with known properties) and measurement methodologies to objectively quantify the performance characteristics of PET systems. Therefore, the "ground truth" is the known physical properties of the phantoms and the reproducible measurements defined by the standard.

8. The Sample Size for the Training Set

Not applicable. This document describes the clearance of a medical imaging device (PET/CT scanner) based on hardware and software upgrades, and its adherence to established performance standards. It does not involve a machine learning algorithm that requires a "training set" of data for development.

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

Not applicable (as above).

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