(70 days)
MultiBand SENSE is a software option intended for use on Ingenia 3.0T CX MR Systems. It's indicated for use in magnetic resonance imaging of the brain for diffusion weighted imaging. MultiBand SENSE consists of an acquisition and reconstruction technique allowing simultaneous excitation of multiple volumes to accelerate imaging acquisition times, or increasing coverage or number of diffusion directions without increasing scan time.
The Multiband SENSE feature enables simultaneous excitation and acquisition of multiple volumes for spin echo and gradient echo MR sequences for the purpose of speeding up acquisition times or increasing coverage or resolution without increasing scan time. The simultaneous volume excitation is achieved using a multiband RF pulse. The image unfolding of the simultaneously acquired volumes is done using the SENSE algorithm. The image unfolding is improved by introducing a shift in k-space in the phase direction which is dependent on the volume spatial location, resulting in a spatial shift of the aliased pixels. Artifacts related to mismatch between SENSE reference scan and the clinical scan are minimized using information from a previously acquired Bo map. The MultiBand SENSE feature is available on Ingenia 3.0T and Ingenia 3.0T CX systems, and is compatible with the 32 channel head coil.
The provided text describes the regulatory clearance of MultiBand SENSE and mentions that "Non-Clinical verification and validation tests have been performed with regards to the intended use, the technical claims, the requirement specifications and the risk management results." It further states that these tests "demonstrate that the proposed MultiBand SENSE... Meets the acceptance criteria and is adequate for its intended use."
However, the specific details of the acceptance criteria, the study demonstrating compliance, reported device performance, sample sizes, ground truth establishment, expert qualifications, or adjudication methods are not provided in the given document. The document summarizes that adherence to international and FDA-recognized consensus standards and device-specific guidance formed the basis for demonstrating substantial equivalence, rather than a detailed comparative effectiveness study of the MultiBand SENSE itself against a "without AI" baseline or a standalone performance study.
Therefore, based on the provided text, I cannot provide the requested information in detail. The document indicates that a clinical study was not required for this 510(k) submission, and the focus was on demonstrating substantial equivalence through design features, indications for use, fundamental scientific technology, and non-clinical performance testing.
There is no information in the provided document to fill out the table and answer the specific questions about the study that proves the device meets the acceptance criteria.
§ 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.