(198 days)
The Siemens MR-PET system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.
These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders.
The MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MRimages, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MRsafe biopsy needles.
The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.
The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.
The Biograph mMR systems are combined Magnetic Resonance Diagnostic Devices (MRDD) and Positron Emission Tomography (PET) scanners. These systems are designed for whole body oncology, neurology and cardiology examinations. The Biograph mMR systems provide reqistration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (MR and PET). Additional components of the system include: a patient bed and both, the acquisition and processing, workstations with associated software.
The Biograph mMR includes a 3T superconducting magnet, gradient coil, body coil and local RF coils based on those of the predicate MAGNETOM Verio 3T system. The Biograph mMR PET detectors have been updated from those of the predicate Biograph mCT to allow them to be integrated into the bore of the MR. This allows for simultaneous, precisely aligned whole body MR and PET acquisition.
Biograph mMR software is based on a combination of MAGNETOM Verio with B17 software, and Biograph mCT software. It is 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 mMR system, the subject of this application, is substantially equivalent to the commercially available devices above with modifications made to integrate the two modalities together into a whole-body system.
The provided text does not contain information about specific acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) premarket notification for the Siemens Biograph mMR, outlining its description, indications for use, and a letter from the FDA confirming substantial equivalence to predicate devices.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
The document primarily focuses on establishing substantial equivalence based on the device's design, intended use, and compliance with recognized standards, rather than presenting a performance study with explicit acceptance criteria.
§ 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.