(26 days)
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 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 mCT systems are combined multi-slice X-Ray Computed Tomoqraphy 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:
- . Improvements to Radiation Dose Monitoring
- . Radiation Dose Reduction Initiatives
- Image Quality improvements .
- . Workflow Enhancements
The provided document does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or information on sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML context. This submission is for modifications to a combined PET/CT system, focusing on improvements to existing functionalities rather than the introduction of new AI-driven diagnostic capabilities.
The document discusses general safety and effectiveness through risk management (ISO 14971:2007) and adherence to industry standards (IEC 60601-1 series, 21 CFR 1020.30, 21 CFR 1020.33), along with verification and validation of systems according to documented procedures. However, it does not provide quantitative acceptance criteria or a specific study designed to "prove" the device meets such criteria in terms of diagnostic performance metrics like sensitivity or specificity.
The modifications mentioned are:
- Improvements to Radiation Dose Monitoring
- Radiation Dose Reduction Initiatives
- Image Quality improvements
- Workflow Enhancements
These improvements are intended to maintain or enhance the already established performance of the Biograph mCT systems. The submission asserts "no changes implemented... impact either the fundamental technology or the indications for use" and that the modified device is "substantially equivalent to the currently commercially available predicate device." This indicates that the primary assessment for this 510(k) was based on demonstrating equivalence and maintaining safety and performance, rather than providing new performance studies with specific acceptance criteria that would typically be seen for a novel diagnostic algorithm.
Therefore, I cannot provide the requested information for acceptance criteria, device performance tables, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, or ground truth specifics, as these are not present in the provided text.
§ 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.