(104 days)
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.
| Performance Criteria (PET) | Reported Device Performance (Average) | Acceptance (Standard PET) | Acceptance (TrueV PET) |
|---|---|---|---|
| Resolution – Full Size | |||
| Transverse Resolution FWHM @ 1 cm | Pass | = 5.8 cps/MBq | >= 10.9 cps/MBq |
| Count Rate peak NECR | Pass | >= 78 kcps @ = 135 kcps @ = 285 kcps @ = 465 kcps @ |
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.