mDIXON is a software option intended for use on Intera 1.5T, Achieva 1.5T and Achieva 3T. MR Systems. It is indicated for magnetic resonance imaging of the chest, abdomen and pelvis. mDIXON is a multipoint (echo) method for 3D clinical imaging with the possibility to reformat into multiple planes (axial, sagittal and coronal). mDIXON provides improved fat suppression, increased scan speed in addition and/or an improved signal-to-noise relative to other current 3D volumetric fat suppressed imaging methods

Device Description

The modified-DIXON (mDIXON) sequence is a novel two and multi-point method for 2D and 3D water-fat magnetic resonance imaging. mDIXON is a modification of previous DIXON implementations due to the unrestricted echo-time (TE) approach. This allows more freedom in protocol optimization resulting in more efficient (faster) scanning and an increase in signal to noise (SNR). Additionally, it provides a technique for improved fat suppression (in comparison to other current 3D volumetric fat suppressed imaging methods.) While the primary use is for torso imaging, it may also be applicable to other anatomies requiring in- and opposed-phase, water-only, and/or fatonly imaging. While the current 3D volumetric fat suppressed technique (e-THRIVE) is an imaging method, mDIXON is a multi echo sequence with multiple gradient echo readouts. Phase and amplitude of complex data acquired at different echo times are used to separate the water and fat signals. The separation is made possible by the chemical shift difference between water and fat. The resultant images can be reconstructed to produce "water-only" images, "fat-only" images and in-phase/opposed-phase images (synthesized from the acquired multiecho images). The fat suppression is enhanced especially at the edges of larger fields of view due to the mDIXON reconstruction algorithm and its use of the chemical shift difference between water and fat.

AI/ML Overview

Acceptance Criteria and Study for Philips mDIXON Software Option (K102344)

The provided document describes the Philips mDIXON software option for MR systems. It highlights the device's improvements over existing 3D volumetric fat-suppressed imaging methods, specifically regarding fat suppression, scan speed, and signal-to-noise ratio (SNR). However, it does not explicitly state specific numerical acceptance criteria or detail a formal clinical study to prove these criteria.

Instead, the documentation focuses on:

Verification and Validation (V&V) Testing: Stating that "mDIXON verification and validation tests were performed on the complete system relative to the requirement specification and risk management results. Corresponding test results are included in this submission." This implies that internal tests were conducted against pre-defined requirements, but the specifics of these requirements and their quantitative thresholds are not provided in this summary.
Substantial Equivalence: The primary strategy for regulatory clearance (510(k)) relies on demonstrating substantial equivalence to predicate devices (INTERA 1.5T, ACHIEVA 1.5T, ACHIEVA 3.0T MR systems Release 2.5-series and the IDEAL software option). The core argument is that the mDIXON option does not introduce new risks and maintains the safety and effectiveness profile of these predicate devices, while offering improved performance.

Given the information, a table of explicit acceptance criteria and corresponding performance cannot be created directly as they are not explicitly mentioned in this summary. The assessment revolves around the general claims of improvement and the maintenance of safety and effectiveness as per predicate devices.

Based on the provided text, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly list quantitative acceptance criteria for mDIXON. The performance claims are qualitative improvements over current 3D volumetric fat-suppressed imaging methods. The "acceptance" is implied by the successful completion of V&V testing and the FDA's determination of substantial equivalence.

Acceptance Criteria Category	Specific Acceptance Criteria (as implied)	Reported Device Performance (as stated)
Fat Suppression	Improved fat suppression compared to other current 3D volumetric fat-suppressed imaging methods.	"mDIXON provides improved fat suppression...especially at the edges of larger fields of view"
Scan Speed	Increased scan speed compared to other current 3D volumetric fat-suppressed imaging methods.	"increased scan speed"
Signal-to-Noise Ratio (SNR)	Improved SNR relative to other current 3D volumetric fat-suppressed imaging methods.	"and/or an improved signal-to-noise"
Safety & Effectiveness	No new risks introduced compared to predicate devices; maintain overall safety and effectiveness.	"mDIXON software option does not induce any other risks than already indicated for their predicate devices with the same safety and effectiveness."
Compliance	Systems comply with international and relevant FDA standards.	"The INTERA 1.5T, ACHIEVA 1.5T and ACHIEVA 3.0T systems comply with the international IEC and ISO standards identified in the submission."

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

Sample Size: Not specified. The document only mentions "mDIXON verification and validation tests were performed," but no details on the number of cases, subjects, or data points in the test set.
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

Not specified. The document does not describe the involvement of human experts or ground truth establishment for specific test cases. The V&V process likely involved technical assessments rather than clinical evaluations by experts described here.

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

Not specified. There is no mention of an adjudication process for a test set in the summary provided.

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, a MRMC comparative effectiveness study is not mentioned. This document pertains to a software option for an MR system, enhancing image acquisition and reconstruction, not a diagnostic AI tool for interpretation. Therefore, a study comparing human reader performance with and without AI assistance is not described or relevant for this type of device based on the provided information.

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

The mDIXON is itself an "algorithm only" (software option) that generates images. The "standalone" performance
is assessed by its ability to produce images with improved characteristics (fat suppression, scan speed, SNR) compared to existing methods. The validation of these characteristics is stated to have been performed through V&V tests, but no specific study details are given beyond this general statement. Essentially, the device is the algorithm, and its performance is evaluated on the quality of the output images.

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

Not explicitly stated. Given the nature of the device (image acquisition/reconstruction), the "ground truth" for the V&V tests would likely be related to objective measures of image quality (e.g., quantitative fat suppression metrics, SNR measurements, acquisition time) compared against a reference standard or expected performance, rather than clinical ground truth like pathology or expert consensus on disease presence.

8. The sample size for the training set

Not applicable/Not specified. The mDIXON sequence is a physics-based magnetic resonance imaging technique, not a machine learning model that requires a "training set" in the conventional sense. Its development would involve engineering and physics principles rather than data-driven training.

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

Not applicable. See point 8.

Summary

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KI02344

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS NOV – 9 2010

The following information is being submitted in accordance with the requirements of 21 CFR 807.92.

General information

Company Name: Address:

Registration No .: Contact person:

Philips Medical Systems Nederland BV Veenpluis 4-6 5684 PC Best, Netherlands, 3003768277 Lynn Harmer Sr. Manager, Regulatory Affairs Tel: (425) 487-7312 Fax: (425) 487-8666 Lynn. Harmer@Philips.com

Date Prepared: Device (Trade) Name:

Classification Name: Regulatory Number: Classification: Product code:

August 16, 2010 mDIXON Software option for INTERA 1.5T, ACHIEVA 1.5T and ACHIEVA 3.0T MR systems Magnetic Resonance Diagnostic Device (MRDD) 892.1000 Class II 90L--NH 90L--NI

Performance standards:

NEMA voluntary standards, FDA MR Diagnostic Device Guidance, UL and IEC 60601 appropriate safety standards and/or draft standards are used.

Predicate Device(s):

INTERA 1.5T, ACHIEVA 1.5T and ACHIEVA 3.0T MR systems Release 2.5-series (FDA reference K063559) and the IDEAL software option (FDA reference K072998) are predicate devices for mDIXON software option.

Intended Use:

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K102344

510(k) Summary of Safety and Effectiveness Philips mDIXON software option

Page 2 of 2

Device description:

1 Summary of non-clinical testing

The INTERA 1.5T, ACHIEVA 1.5T and ACHIEVA 3.0T systems comply with the international IEC and ISO standards identified in the submission. Modifications to the requirements of the predicate device were developed under an approved design control process in conformance to the standard EN ISO 13485:2003.

mDIXON verification and validation tests were performed on the complete system relative to the requirement specification and risk management results. Corresponding test results are included in this submission.

Based on the test results Philips Medical Systems believes that the INTERA 1.5T, ACHIEVA 1.5T and ACHIEVA 3.0T systems are still as safe and effective with additional mDIXON software option.

2 General Safety and Effectiveness

mDIXON software option does not induce any other risks than already indicated for their predicate devices with the same safety and effectiveness.

3 Substantial Equivalence

It is the opinion of Philips Medical Systems that the Philips mDIXON Software option for INTERA 1.5T, ACHIEVA 1.5T and ACHIEVA 3.0T MR systems is substantially equivalent to the legally marketed devices.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's seal on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The text is in a simple, sans-serif font and is underlined.

Public Health Service

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

Ms. Lynn Harmer Sr. Manager, Regulatory Affairs Philips Healthcare 22100 Bothell Everett Highway BOTHELL WA 98021-8431

NOV - 9 2010

Re: K102344

Trade/Device Name: mDixon Software option for INTERA 1.5T, ACHIEVA 1.5T and ACHIEVA 3.0T MR Systems

Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: August 17, 2010 Received: August 18, 2010

Dear Ms. Harmer:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Dan

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K102344

Appendix A2

Indication for use

NOV - 9 2010

5 10(k) Number (if known):

Device Name : mDIXON Software option for INTERA 1.5T, ACHIEVA 1.5T and ACHIEVA 3.0T MR systems

Indication For Use :

mDIXON is a software option intended for use on Intera 1.5T, Achieva 1.5T and Achieva 3T MR Systems. It's indicated for magnetic resonance imaging of the chest, abdomen and pelvis.

mDIXON is a multipoint(echo) method for 3D clinical imaging with the possibility to reformat into multiple planes (axial, sagittal and coronal). mDixon provides improved fat suppression, increased scan speed in addition and/or an improved signal-to-noise.

Prescription Use X (Per 21 CFR 801.109)

OR Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102344

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.