(15 days)
Imaging of:
- The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging.]
- Fluid Visualization.
- 2D / 3D Imaging
- MR Angiography / MR Vascular Imaging.
- Blood Oxygenation Level Dependent (BOLD) imaging
- Perfusion / Diffusion Imaging.
- Proton Spectroscopy.
The EXCELART Vantage™ ZGV system is comparable to the current EXCELART Vantage™ XGV/AGV system; with the following exceptions.
- The maximum gradient strength and the maximum slew rate have been increased.
- The clock of CPU of computer system was increased from 2.8GHz to 3.2GHz.
- SAR 1st level operating mode as specified in IEC 60601-2-33 (2002).
- The performance (Min.TR/Min.TE / Min.Slice thickness) of a sequence has been improved.
The provided text describes specific features and safety parameters of a Magnetic Resonance Diagnostic Device Accessory (MRT-1503/P5, EXCELART Vantage™ ZGV) and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, a specific study proving those criteria were met, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, or MRMC studies.
The document is a 510(k) summary for a submission to the FDA, primarily focused on demonstrating "substantial equivalence" to a previously cleared device (EXCELART Vantage™ XGV/AGV, K032490). The changes highlighted are hardware and software modifications that improve performance or allow for access to specific operating modes, but these are not presented as acceptance criteria against specific performance metrics (e.g., sensitivity, specificity for a diagnostic task).
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria or a study proving their fulfillment from the provided text.
The document states:
- "IMAGING PERFORMANCE PARAMETERS: No changes from the previous submission, K032490." This implies that the imaging performance is expected to be the same as the predicate device, but it doesn't detail what those performance parameters are or how they were assessed.
- "TOSHIBA Medical Systems Corporation believes that the new EXCELART Vantage™ ZGV (model MRT-1503/P5) Magnetic Resonance Imaging (MRI) system is substantially equivalent to the current EXCELART Vantage™ XGV/AGV (model MRT-1503/P3, MRT-1503/P2) (K032490 ) cleared on August 21, 2003." This is the core argument for clearance, not a report of a specific study proving the new device's performance against defined acceptance criteria.
The FDA's letter confirms the substantial equivalence determination based on the indications for use.
To answer your request, a different type of document, such as a clinical validation report or a detailed performance specification document, would be needed.
§ 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.