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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.

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MultiBand SENSE is a software option intended for use on Achieva and Ingenia 1.5T & 3.OT MR Systems. It's indicated for use in magnetic resonance imaging of the brain for BOLD fMRI. MultiBand SENSE consists of an acquisition and reconstruction technique allowing simultaneous excitation of multiple volumes to accelerate imaging acquisition times or increasing coverage or resolution without increasing scan time.

The MultiBand SENSE technique enables simultaneous excitation and acquisition of multiple volumes or slices for the purpose of speeding up acquisition times or increasing coverage or resolution at constant scan time. The simultaneous excitation is done using a multi-band radiofrequency pulse. The unfolding of the simultaneously acquired volumes is done using the SENSE algorithm. The unfolding process (solving the linear equation of the SENSE algorithm) is improved by introducing a linear phase over k-space in the volume direction resulting in a spatial shift of the aliased pixels. The phase shift is applied by additional blip-gradients in the slice direction or switching between different RF pulses, and compensated for in reconstruction by a translation of the coil sensitivity data before the SENSE unfolding. The feature consists of:

• Modulated RF pulses exciting 2 or more slices
• Blip-gradients to introduce a phase shift for improved unfolding ●
• New parameterization of the SENSE calculations ●
• Shifting coil sensitivities in reconstruction to correct for linear phase shift. ●

MultiBand SENSE is supported on the following systems:

• . 3.0T Ingenia
• 3.0T Achieva ●
• 1.5T Ingenia ●
• . 1.5T Achieva

The functionality is supported on all available gradient performance levels. Optimized protocols will be provided for the different performance points. MultiBand SENSE is supported on the centralized data acquisition systems of the Achieva systems as well as the digitally networked data acquisition system of the Ingenia systems. The data acquisition system is fully transparent to the MultiBand SENSE pulse sequences and reconstructions.

The main functional units in the software are:

• Methods (acquisition of MR signals by means of MR pulse sequences) -
• Reconstruction (transforming the MR signals to images) -
• -Patient Administration (storing of the images in the database and providing access)
• Viewing (display of images) -

The technical impact of the feature MultiBand SENSE comprises:

• -Methods: Introduction of a modulated RF pulse. Apply blipped gradients. Provide new parameterization for SENSE reconstruction.
• Reconstruction: Read new parameterization of SENSE calculations. Shift coil sensitivities before SENSE calculations.

No off-the-shelf software is used for the feature MultiBand SENSE. The off-the-shelf software used in the basic MR system is cleared. MultiBand SENSE is not designed to be connected to an external network.

MultiBand SENSE does not require any change of the hardware platform. The extension introduced by Multiband SENSE, are in methods pulse sequence code, and in reconstruction only for a new parameterization of a cleared SENSE unfolding calculation. Those run on the host computer characteristics :

• Manufacturer: HP; Model: Z420; Processor clock: 3.5 GHz; RAM: 64 GB RAM; -Processors: six core with hyper threading
• Operating system: Windows 7, 64 bits -

The only new element for the operator of the Multiband SENSE feature in this clinical routine workflow is:

• Protocol selection: The operator selects an ExamCard with Multiband SENSE protocols -
• Planscan phase: Optionally the operator may want to change the predefined Multiband acceleration factor.

All other steps are not changed. The generated image types can be viewed, post-processed, printed and archived as any other image type.

This document is a 510(k) Summary for the Philips MultiBand SENSE device, a software option for MRI systems. It focuses on demonstrating substantial equivalence to a predicate device. The information provided is primarily related to verification and validation, rather than a detailed comparative effectiveness study with specific acceptance criteria and statistical analysis as might be found in a clinical trial report.

Here's an analysis of the provided text in relation to your questions, noting where information is explicitly stated, implied, or absent:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of quantitative acceptance criteria and corresponding device performance metrics in the way a statistically powered study might. Instead, it describes general successful outcomes of verification and validation testing.

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