mDIXON XD is a software option intended for use on Achieva, Ingenia 1.5T & 3T MR Systems. It is indicated for use in Magnetic Resonance Imaging of the human body. mDIXON XD is an enhanced 2-point fat-free mDIXON technology, available for gradient echo and spin echo acquisitions. mDIXON XD enables the combination of a fat-free technology with the MultiVane XD motion-free technique for anatomies such as head. mDIXON XD also enables subtractionless MR Angiography in areas of the body where exogenous contrast media has been approved for MR imaging.

Device Description

mDIXON XD provides an improved water/fat reconstruction algorithm (7-peak fat modeling, B0correction and fat-shift correction). mDIXON XD relies on the 2-point mDIXON fat-free technology making use of unrestricted echo times and is capable of generating four image contrasts (Water, Fat, In-Phase, Out-Phase) in one scan. mDIXON XD can be used with the following:

Multivane XD (motion correction) for the head
MR Angiography (subtractionless MRA), removes the need for the subtraction of the pre-● and post-contrast enhanced images.
Gradient echo (FFE Fast Field Echo) and turbo spin echo (TSE) sequences to achieve ● efficient fat-free scanning compatibility, even at large FOV or sub-millimetric resolutions
mDIXON XD 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. mDIXON XD 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 pulse sequences and mDIXON XD reconstructions.

AI/ML Overview

The provided text is a 510(k) summary for the Philips Medical Systems' mDIXON XD device. It describes the device, its intended use, and provides a brief summary of nonclinical and clinical tests. However, it does not contain specific acceptance criteria, detailed study designs, or quantitative performance metrics as requested in the prompt.

Therefore, I cannot provide a table of acceptance criteria and the reported device performance, nor can I answer questions about sample sizes for test/training sets, data provenance, number/qualifications of experts, or adjudication methods, as this information is not present in the provided document.

Here's what can be extracted based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as quantitative metrics. The document broadly states that the device was "successful" and "passed" clinical user needs.
Reported Device Performance:
- For total body and head/neck examinations: Image Quality, fat suppression, and fat suppression over large FOV were similar or better with mDIXON XD compared to e-Thrive.
- For cardiac examinations: Image quality and fat suppression were better with mDIXON XD.
- For MultiVane XD in combination with mDIXON TSE: Motion related artifacts were reduced compared to mDIXON TSE alone.
- MultiVane XD with mDIXON XD can be used with T2 in head imaging.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The term "clinical user needs" suggests clinical evaluation, but details on expert involvement are absent.

4. Adjudication method for the test set:

Not specified.

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 involving human readers and AI assistance is described. The comparison is between mDIXON XD and existing technologies (e-Thrive, mDIXON TSE alone).

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

The testing described is on the "device" as a whole, which is a software option for MR systems. It's an "algorithm only" performance in the sense that it evaluates the output of the software. However, it's not a standalone AI device in the modern sense of a diagnostic AI assisting or replacing a human. The clinical validation assesses image quality and artifact reduction.

7. The type of ground truth used:

The "ground truth" implicitly used is expert judgment and assessment of "Image Quality," "fat suppression," and "motion related artifacts" as perceived by "clinical user needs." It's based on subjective clinical assessment rather than objective pathology or outcomes data.

8. The sample size for the training set:

Not specified. The document describes verification and validation but does not detail a separate training set, suggesting this is a software update/feature validation rather than a deep learning algorithm that requires a distinct training phase.

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

Neither a training set nor its ground truth establishment is mentioned.

Summary

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

March 20, 2015

Philips Medical Systems Nederland B.V. Susan Ouick Regulatory Affairs Specialist 595 Miner Rd CLEVELAND OH 44094

Re: K143128

Trade/Device Name: mDIXON XD Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: February 06, 2015 Received: February 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,

Robert A Ochs

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)	K143128
Device Name	mDIXON XD
Indications for Use (Describe)
mDIXON XD is a software option intended for use on Achieva, Ingenia 1.5T & 3T MR Systems. It is indicated for use in Magnetic Resonance Imaging of the human body. mDIXON XD is an enhanced 2-point fat-free mDIXON technology, available for gradient echo and spin echo acquisitions. mDIXON XD enables the combination of a fat-free technology with the MultiVane XD motion-free technique for anatomies such as head. mDIXON XD also enables subtractionless MR Angiography in areas of the body where exogenous contrast media has been approved for MR imaging.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

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PHILI

Philips Medical Systems Nederland B.V.

510(k) Summary

mDIXON XD

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 October 29
Trade Name of Device:	mDIXON XD
Classification:	Class II
Regulatory Section:	Magnetic Resonance Diagnostic Device.892.1000
Product Code:	90LNH

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510(k) Summary mDIXON XD

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

1. Primary Predicate Device: mDIXON
Manufacturer:	Philips Healthcare
Predicate Device k#:	K102344
2. Reference Devices:	MultiVane and e-THRIVE (Ingenia MR System)
Manufacturer:	Philips Healthcare
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

Multivane XD (motion correction) for the head
MR Angiography (subtractionless MRA), removes the need for the subtraction of the pre-● and post-contrast enhanced images.
Gradient echo (FFE Fast Field Echo) and turbo spin echo (TSE) sequences to achieve ● efficient fat-free scanning compatibility, even at large FOV or sub-millimetric resolutions

mDIXON XD 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. mDIXON XD 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 pulse sequences and mDIXON XD reconstructions.

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

mDIXON XD is a software option intended for use on Achieva. Ingenia I .5T & 3T MR Systems. It is indicated for use in Magnetic Resonance Imaging of the human body. mDIXON XD is an enhanced 2-point fat-free mDIXON technology, available for gradient echo and spin echo acquisitions. mDIXON XD enables the combination of a fat-free technology with the MultiVane XD motion-free technique for anatomies such as head. mDIXON XD also enables subtractionless MR Angiography in areas of the body where exogenous contrast media has been approved for MR imaging.

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

The main functional units in the software are:

(software for controlling and diagnosing the hardware) - MRChains
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 impact of mDIXON XD on these functional units are:

MRChains: Provide static B0-field information, as measured at system installation time. -
Methods: Use an existing multi-echo (usually 2 echoes) FFE, TFE or multi-acquisition TSE for mDIXON XD, within the cleared limits provided by the basic MR system. The requested output image types can be specified by the user in the scan protocol.
-Reconstruction: Add a new calculation function that calculates water, fat, IP and OP images. Apply a fat-peak-model and B0-field information to separate water from fat. Make use of water-fat shift correction and geometry correction.
-Patient Administration and Viewing: enable storage and display of the output images with appropriate labels (water, fat, IP, OP)

No off-the-shelf software is used for mDIXON XD. The off-the-shelf software used in the basic MR system is cleared. mDIXON XD is not designed to be connected to an external network. mDIXON XD does not require any change of the hardware platform. The major extensions introduced by mDIXON XD are in methods pulse sequence code, and in reconstruction for the enhanced calculation. Those run on the host computer:

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 -

Changes to operator workflow for mDIXON XD are:

Protocol selection: The operator selects an ExamCard with mDIXON XD protocols -
Planscan phase: Optionally the operator may want to change the predefined selection of output image-types.
For mDIXON XD MRA: During scanning no pre-contrast baseline has to be scanned, saving one multi-station table-stroke, compared to conventional MRA.

All other steps are not changed. The generated image types can be viewed, post-processed, printed

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and archived as any other image type.

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

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

The verification testing showed the examcards could be loaded, the correct parameters were listed for each scan, there were no issues when turning on SENSE, the four image types could be selected, all scans ran properly and images were provided.

The conclusion from this report is:

All the tests performed for mDIXON XD were successful. Workflow was smooth and no problems occurred.

All defects have been corrected.

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 testing showed that for total body and head/neck examinations, the Image Quality, fat suppression and fat suppression over large FOV was similar or better with mDIXON XD compared to e-Thrive. For cardiac examinations the image quality and fat suppression were better with mDIXON XD. For MultiVane XD in combination with mDIXON TSE, the motion related artifacts were reduced compared to mDIXON TSE alone and the MultiVane XD with mDIXON XD can be used with T2 in head imaging.

The conclusion from testing the device is:

The clinical validation of mDIXON XD has completed successfully. All clinical user needs have passed for mDIXON XD on the Achieva and Ingenia 1.5T and 3T systems. All defects have been analyzed and are verified to be solved and will be closed, 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.

mDIXON XD 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 mDIXON XD 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.