(11 days)
The QD C-Spine Coil provides imaging of the cervical spine anatomy; dependent upon patient Inc Q & Epil sensitivity may additionally image upper thoracic and lower cranial structures.
The MR system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved crosssectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattion time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
Anatomical Region: Head, Body, Spine, Extremities
Nucleus excited: Proton
Diagnostic uses: 2D T1-/T2-weighted imaging; T1, T2, proton density measurements; MR Angiography
Imaging capabilities: 2D Spin Echo (SE); also with rephase; 2D Gradient Field Echo (GE); also with rephase (2D GR); 2D Inversion Recovery (IR); 2D Fast Spin Echo (FSE); 2D Dual Slice acquisition (SEDS); 3D Spin Echo (SE); 3D Gradient Field Echo (GE); also with rephasing; 3D Steady-state Acquisition with Rephased Gradient Echo (SG); MR Angiography (2D TOF, 3D TOF, half echo, high resolution/high definition); RF Coil Uniformity; Adaptive Image post-processing; ACR/NEMA/DICOM 3 compliant
The MRP-5000 MRI Magnetic Resonance Diagnostic Device is being enhanced by one additional RF Coil (QD C-Spine Coil) to increase the clinical utility of the MRP-5000 in both mobile and stationary configurations.
MRP-5000 software did not need to be revised in order to support full functionality of these coils.
Magnetic Resonance (MR) is based on the fact that certain atomic nuclei have electromagnetic properties which cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nucleus used in current imaging experiments in magnetic resonance. When placed in a magnetic field, there is a slight net orientation or alignment of these atomic nuclei with the magnetic field. The introduction of a short burst of radiofrequency (RF) excitation of wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a reorientation of the proton's magnetization vector. When the RF excitation is removed, the proton relaxes and returns to its original orientation. The rate of relaxation is exponential, and varies with the character of the proton and its adjacent molecular environment. This reorientation process is characterized by two exponential relaxation times called T1 and T2 which can be measured.
These relaxation events are accompanied by an RF emission or echo which can be measured and used to develop a representation of these emissions on a three dimensional matrix. Spatial localization is encoded into the echo by varying the RF excitation and by appropriately applying magnetic field gradients in x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of NMR characteristics of the nuclei under consideration can be constructed by using image processing techniques similar to those used in CT.
For magnetic fields up to 1.5T. the RF frequencies commonly used range up to 65MHz. The RF fields have pulse powers from several watts to greater than 10 kilowatts, and repeat at rates from once every few seconds to greater than fifty per second. The time-varying magnetic gradient fields have a typical duration of sub-millisecond to several milliseconds.
The provided text is a 510(k) summary for a medical device (QD C-Spine Coil for an MRI system) and a clearance letter from the FDA. It does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria in the format requested. The document primarily focuses on demonstrating substantial equivalence to a predicate device and outlining the device's intended use and technical characteristics.
Therefore, I cannot extract the requested information to fill in the table and answer the study-related questions. The document does not describe a performance study with detailed acceptance criteria, sample sizes, expert involvement, or comparative effectiveness.
The document states: "MRP-5000 software did not need to be revised in order to support full functionality of these coils." and "5.0 DEVICE TECHNOLOGICAL CHARACTERISTICS: Identical to the Predicate Device." This suggests that the clearance was based on the substantial equivalence to existing technology rather than a specific performance study against defined acceptance criteria for the new coil itself.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.