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The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Position 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 TruePoint Family of 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 TruePoint 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 TruePoint PET/CT Family software is a command based program used for patient manaqement, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.

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

• . General
  • Update of the operating system to Windows 7 for the ACS and PRS components O for improved sustainability
  • Support for SolidCore implemented for chanqe protection and software O security.
  • updates to address anomalies for CT and PET software o
• synqo software upgrade .
  • o Update of the synqo software to the latest revision (drivers, etc...)
• . Somaris Software Update
  • Upgrade to the latest revision Somaris Software (VB42) (K140232) O
  • Inclusion of MITA Dose check features to be compliant with the MITA dose о requirements. Dose Notification and Dose Alert; Dose Logs; Access and CARE Analytics, CARE Dose 4D etc ...
  • Improvements to scanning and reconstruction workflows o
• PETsynqo software .
  • Update of software to provide for improved consistency of features between all O TruePoint models
  • Update to add Variable Bed Time O
  • Update of the software scatter correction and bed removal O
  • Update of the TrueD software O
  • Improvements to the service tools O
  • O Improvements to workflow

This document describes the Biograph TruePoint PET/CT Family Software, focusing on its substantial equivalence to predicate devices and performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The performance testing for the PET subsystem was conducted in accordance with NEMA NU2:2007 for two configurations: a 3-ring and a 4-ring version of the Biograph TruePoint 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 TruePoint systems, a 3 ring version and a 4 ring version." It does not specify a sample size in terms of patient data or data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be based on physical measurements of the device's imaging capabilities according to a standard protocol (NEMA NU2:2007), rather than a clinical study with patient data.

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 specifications and measurements according to NEMA NU2:2007, not on expert-established ground truth from clinical images.

4. Adjudication Method for the Test Set

Not applicable. The described testing is a technical performance evaluation, not a clinical study requiring adjudication of image interpretation.

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

No. This premarket notification describes the evaluation of software updates for a PET/CT system, focusing on its technical performance and substantial equivalence to existing devices. It does not mention an MRMC comparative effectiveness study involving human readers with and without AI assistance. The described "AI" would be the image reconstruction and processing algorithms inherent in the PET/CT software, not a separate AI application for interpretation.

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

Yes, in a sense. The performance testing outlined in the table is a standalone evaluation of the algorithm and hardware's capabilities to meet specified technical parameters (e.g., resolution, sensitivity, count rate) according to NEMA NU2:2007. This evaluation does not involve human interpretation or a "human-in-the-loop" component for the performance metrics listed.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on the objective measurements and standards defined by NEMA NU2:2007. This standard specifies phantoms and methods for measuring various performance characteristics of PET systems. Therefore, the "ground truth" is the physical reality represented by the phantom and measured by the device according to the NEMA protocol.

8. The Sample Size for the Training Set

Not applicable. This document describes a submission for software updates for an existing medical imaging system and its performance evaluation against a recognized standard (NEMA NU2:2007). It does not involve machine learning model training or a "training set" in that context. The software updates are described as general improvements to sustainability, security, and workflow, and upgrades to existing software components (e.g., operating system, Synqo, Somaris, PETsynqo).

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

Not applicable, as there is no mention of a machine learning training set in this submission.

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