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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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