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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Implied from description of successful tests)	Reported Device Performance
MultiBand SENSE examcards could be loaded	Successful
Correct parameters were listed for each scan	Successful
MultiBand SENSE functioned properly	Successful
Average SNR deviation was <10% for every slice	Achieved
All scans ran properly	Successful
Images were provided	Successful
Workflow was smooth	Successful
No defects were reported	Achieved
For fMRI scans, scan time was shorter with MultiBand SENSE	Achieved
User could increase number of slices with MultiBand SENSE	Achieved
No new hazards were identified	Achieved
All clinical user needs have passed	Successful

Detailed breakdown of other questions:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated. The document refers to "the tests performed" and "fMRI scans" but doesn't quantify the number of cases or subjects used in either non-clinical verification or clinical validation.
Data Provenance: Not explicitly stated. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It describes testing scenarios but not the source of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not explicitly stated. The document mentions "clinical user needs are tested as part of validation" but does not detail how ground truth was established, who the experts were, or their qualifications. The focus is on the functional and performance aspects of the software, not diagnostic accuracy requiring expert consensus on images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not explicitly stated. Given that the "clinical validation" described focuses on functional aspects (scan time, number of slices, workflow) and safety ("no new hazards"), rather than diagnostic accuracy of images, an adjudication method for establishing ground truth on image interpretations is not mentioned or implied to be relevant to the described testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was specifically described as being performed. The document states "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." The validation described confirmed functional improvements (shorter scan time, increased coverage/resolution) due to the technology itself, not an AI assistance to human readers for diagnostic tasks. Therefore, an effect size of human readers improving with AI assistance is not applicable to the described validation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This refers to a standalone performance study, but the device is a technical feature of an MRI system, not an AI algorithm intended for diagnostic interpretation. The functionality of the MultiBand SENSE algorithm (simultaneous excitation, unfolding via SENSE algorithm, blip-gradients, etc.) was tested in a "standalone" sense in that it runs without direct human intervention in its moment-to-moment operation during a scan. The verification and validation activities described confirm the algorithm's proper functioning and impact on imaging parameters. Yes, the "nonclinical tests" and aspects of "clinical tests" essentially represent standalone testing of the device's functionality and performance as an algorithm within the MR system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly stated in terms of diagnostic ground truth. For the "clinical validation" mentioned, the ground truth was related to the functional performance of the device:

Whether scan times were shorter when MultiBand SENSE was enabled.
Whether the number of slices could be increased without increasing scan time.
Whether the SNR deviation was within acceptable limits.
Smoothness of workflow and absence of defects/hazards.
This is a performance-based ground truth specific to the technical capabilities of the MRI sequence, not a diagnostic ground truth derived from pathology or expert consensus on image findings.

8. The sample size for the training set

The document describes the device as a "software option" and a "technique" that involves "Modulated RF pulses," "Blip-gradients," "New parameterization of the SENSE calculations," and "Shifting coil sensitivities in reconstruction." This sounds like an algorithmic and sequence-based enhancement, rather than a machine learning or AI model that typically requires a large training set of data. Therefore, the concept of a "training set" in the context of machine learning is not applicable to this device as described.

9. How the ground truth for the training set was established

As the concept of a "training set" for a machine learning model is not applicable here, there is no information on how its ground truth would have been established.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 8, 2015

Philips Medical Systems, Nederland B.V. % Ms. Susan Quick Regulatory Affairs Specialist Philips Medical Systems (Cleveland), Inc. 595 Miner Road CLEVELAND OH 44143

Re: K143606

Trade/Device Name: Multiband Sense Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH Dated: April 17, 2015 Received: April 20, 2015

Dear Ms. Quick:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'Hara for

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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PHILIF

Philips Medical Systems Nederland B.V.

510(k) Summary

MultiBand SENSE

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

I. General Information 21 CFR 807.92 (a)(1), (2)

Company Name:	Philips Medical Systems Nederland B.V.
Address:	Veenpluis 4-65684 PC BestThe Netherlands
Registration No .:	3003768277
Contact Person:	Susan Quick595 Miner RdCleveland, Oh 44143Tel: (440)-483-2291Fax: (440)-483-4799E-mail: susan.quick@philips.com
Prepared (date):	2014 December 12
Trade Name of Device:	MultiBand SENSE
Classification:	Class II
Regulatory Section:	Magnetic Resonance Diagnostic Device.892.1000
Product Code:	90LNH

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510(k) Summary MultiBand SENSE

21 CFR 807.92(a)(3):Legally marketed predicate device to which substantial equivalence is claimed:

1. Primary Predicate Device: SENSE
Manufacturer:	Philips Medical Systems Nederland BV
Predicate Device k#:	K110151

21 CFR 807.92(a)(4): Description of the device that is the subject of this premarket notification:

Summary of functions of the device and its major components

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

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21 CFR 807.92(a)(5): Intended Use

21 CFR 807.92(a)(6): Technological Characteristics:

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.

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.

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21 CFR 807.92(b)(1): Brief discussion of nonclinical tests submitted, referenced or relied on in this premarket notification:

MultiBand SENSE has been verified to function with the Achieva and Ingenia 1.5T and 3.0T MR systems.

The verification testing showed the MultiBand SENSE examcards could be loaded, the correct parameters were listed for each scan. MultiBand SENSE functioned properly together, the average SNR deviation was <10% for every slice, all scans ran properly and images were provided.

The conclusion from this report is: All the tests performed for MultiBand SENSE were successful. Workflow was smooth and no problems occurred. No defects were reported.

21 CFR 807.92(b)(2): Brief discussion of clinical tests submitted, referenced or relied on in this premarket notification:

Clinical user needs are tested as part of validation. The validation testing showed that for fMRI scans with MultiBand SENSE enabled the scan time was shorter when compared to fMRI with MultiBand disabled for the same number of slices. Also the user could increase the number of slices when using MultiBand SENSE under the scan time recorded without MultiBand SENSE.

The conclusion from testing the device is:

The clinical validation of MultiBand SENSE has completed successfully. All clinical user needs have passed for MultiBand SENSE on the Achieva and Ingenia 1.5T and 3T systems. No new hazards were identified.

21 CFR 807.92(b)(3): The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph (a)(3) of this section:

The nonclinical and clinical tests have demonstrated that the device is safe and works according to its intended use.

MultiBand SENSE software does not introduce new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems considers MultiBand SENSE Software to be substantially equivalent to the above mentioned predicate device.

Regulation Number and Section

§ 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.