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The Siemens Biograph HD 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 HD 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 HD 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 HD 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 Biograph HD systems which are the subject of this application are substantially equivalent to the commercially available Biograph 64/40 systems. Modifications include:

• . Integration of system with the current Siemens Medical Solutions industrial design
• . Improvement of performance characteristics of the PET and CT.

This document is a 510(k) premarket notification for the "Biograph HD Systems" by Siemens Medical Solutions USA, Inc. This submission focuses on establishing substantial equivalence to a predicate device (Biograph 64, 40) for a combined PET/CT scanner. It does not contain a study comparing AI performance against acceptance criteria. The modifications described are related to industrial design and performance improvements of the PET and CT components, not the introduction of artificial intelligence functionality.

Therefore, most of the requested information regarding acceptance criteria and AI performance evaluation cannot be extracted from this document as it pertains to a traditional medical device (PET/CT scanner) submission rather than an AI/ML-enabled device.

However, based on the provided text, I can infer some general information about the device and its intended use.

Here's a breakdown of the requested information based on the provided text, with an emphasis on what is not applicable (N/A) due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify acceptance criteria and reported device performance in the context of an AI study. The submission claims substantial equivalence to a predicate device due to "Improvement of performance characteristics of the PET and CT," but no specific metrics or targets are provided in the text for acceptance criteria.

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

N/A - This 510(k) submission is for a combined PET/CT scanner and does not present data from a test set for an AI algorithm.

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

N/A - This 510(k) submission is for a combined PET/CT scanner and does not present ground truth established by experts for an AI algorithm.

4. Adjudication Method for the Test Set

N/A - This 510(k) submission is for a combined PET/CT scanner and does not describe an adjudication method for an AI algorithm's test set.

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

N/A - This document is for a combined PET/CT scanner and does not describe an MRMC study related to AI assistance.

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

N/A - This document is for a combined PET/CT scanner and does not describe a standalone AI algorithm performance study.

7. The Type of Ground Truth Used

N/A - This document is for a combined PET/CT scanner and does not discuss ground truth in the context of validating an AI algorithm. The core functionality is to produce images; the "ground truth" for these images would be the physical reality of the patient's anatomy and physiology as depicted by a correctly functioning scanner.

8. The Sample Size for the Training Set

N/A - This document is for a combined PET/CT scanner and does not discuss a training set for an AI algorithm.

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

N/A - This document is for a combined PET/CT scanner and does not discuss how ground truth was established for an AI algorithm's training set.

Summary from the document:

• Device Name: Biograph HD Systems
• Device Type: Combined multi-slice X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems.
• Purpose: Designed for whole body oncology, neurology, and cardiology examinations. Provides registration and fusion of high-resolution metabolic and anatomic information.
• Modifications from Predicate: Integration with current Siemens Medical Solutions industrial design and improvement of performance characteristics of the PET and CT.
• Safety and Effectiveness: Ensured via risk management (ISO 14971) and adherence to industry standards (IEC 60601-1 series, 21 CFR 1020.30, 21 CFR 1020.33) to minimize electrical, mechanical, and radiation hazards.
• Intended Use: To be utilized by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing, staging, and restaging of lesions, tumors, disease, and organ function for evaluation of cardiovascular disease, neurological disorders, and cancer. Also for radiotherapy treatment planning and interventional radiology procedures.

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