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The Siemens Biograph Horizon PET/CT systems are combined 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 Horizon PET/CT system is a combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. This system is designed for whole body oncology, neurology and cardiology examinations. The Biograph Horizon scanners 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 Horizon 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 provided document is a 510(k) summary for the Biograph Horizon PET/CT system. It details the device, its intended use, and performance testing, primarily focusing on its substantial equivalence to a predicate device. However, it does not contain the specific information required to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria for image interpretation by an AI algorithm.

The performance testing described is for the physical performance of the PET and CT components of the hardware, not for an AI algorithm's ability to detect, localize, diagnose, or stage lesions, tumors, disease, or organ function. The study referenced is a hardware performance test according to NEMA NU2:2012 for PET and FDA Performance Standards for ionizing radiation emitting products for CT.

Therefore, I can only populate parts of your request based on the provided text, and many sections will be "Not Applicable" or "Not Provided" due to the nature of the document being a hardware 510(k) rather than an AI/software 510(k).

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a table of performance criteria and results for the PET component based on NEMA NU2:2012. These are for the physical characteristics of the scanner, not the performance of an AI algorithm interpreting images.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Sample size: Not applicable as this is a hardware performance test, not a clinical study on an AI algorithm's performance on patient data. The test was conducted on two different configurations of the Biograph Horizon PET/CT systems (a 3-ring version and a 4-ring version).
• Data provenance: Not applicable in the context of AI algorithm performance on patient data. The testing was conducted on the physical devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is a hardware performance test. Ground truth was established by physical measurements against NEMA standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable as this is a hardware performance test.

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:

• No. The document explicitly states that the Biograph Horizon PET/CT system helps "appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function." This is a description of the intended use of the imaging system itself, not an AI-powered image analysis tool that assists human readers.

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

• No. The device is a PET/CT scanner, which produces images for human interpretation. The document does not describe any integrated AI algorithm for image analysis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. For the hardware performance tests, the "ground truth" was the physical standards defined by NEMA NU2:2012 and FDA Performance Standards for ionizing radiation emitting products.

8. The sample size for the training set:

• Not applicable. This document does not describe an AI algorithm that would have a training set.

9. How the ground truth for the training set was established:

• Not applicable. This document does not describe an AI algorithm that would have a training set.

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