The Philips Medical Systems' Advanced Diffusion Analysis (ADA) application is a post processing software application to be used by trained professionals including but not limited to physicians and medical technicians. The Philips Medical Systems' Advanced Diffusion Analysis (ADA) application can be used to perform image viewing, process and analysis of MRI Diffusion Weighted Images (DWI).

Device Description

Philips Medical Systems' Advanced Diffusion Analysis (ADA) application is a post-processing software to be used as an advanced visualization application of diffusion MRI medical images. The ADA application is intended to perform image viewing, process and analysis of MRI Diffusion Weighted Images (DWI).

The ADA application can display images acquired at different b-values, where the b-value is a factor that reflects the strength and timing of the gradients used to generate Diffusion-Weighted Images. The ADA application provides advanced supportive analysis and visualization tools of diffusion MRI images and parametric maps, which can be used by the physician for further analysis.

The physician retains the ultimate responsibility for making the final diagnosis.

Key Features:

Support visualization and processing of isotropic diffusion-weighted MRI data.
Calculate and display a computed Diffusion Weighted Image (cDWI) at a b-value of choice.
Support input image registration in a pre-processing step.
Present a default analysis model based on the available original DWI images and provide a selection of alternative available models.
Provide diffusion analysis models, as well as parametric maps of Perfusion fraction (f), Pseudo Diffusion coefficient (D*), Diffusion coefficient (D) and Kurtosis (K).
Provide a 'Goodness of fit' map, 'Goodness of fit' value and fitted curve showing the fitting quality of the selected model.
Display parameter values from user defined ROI's (Regions of Interest).
Display the ROI results in tabular and graphical formats.
Support export of the parametric maps as grayscale or RGB images for visualization in other viewers or PACS systems.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test or training sets, data provenance, expert ground truth establishment, or adjudication methods for the "Advanced Diffusion Analysis (ADA) application."

The FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Olea Sphere V3.0, K152602) rather than presenting a detailed study proving the ADA application meets specific performance acceptance criteria.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications and the risk management results." and "The test results in this 510(k) premarket notification demonstrate that Advanced Diffusion Analysis (ADA) Complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance document, and Meets the acceptance criteria and is adequate for its intended use and specifications."

This indicates that acceptance criteria were established and the device met them. However, the specific metrics and their corresponding values (e.g., accuracy percentages, error rates, etc.) are not detailed in this document. The "reported device performance" is a general statement of compliance rather than specific quantitative results.

Acceptance Criteria (Inferred from general statements)	Reported Device Performance (Inferred from general statements)
Compliance with ISO 14971, IEC 62304, FDA Guidance for Premarket Submissions for Software, NEMA PS 3.1-3.20	Complies with all aforementioned standards and guidance documents.
Adherence to intended use	Adequate for its intended use.
Fulfillment of technological characteristics claims	Meets technological characteristics claims.
Satisfaction of requirement specifications	Meets requirement specifications.
Mitigation of identified risks	Risk management results addressed (device is safe and effective and introduces no new safety issues).
All defined functionality requirements are met.	All defined functionality requirements are met.
All performance claims are met.	All performance claims are met.

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

Sample Size for Test Set: Not specified.
Data Provenance: Not specified. It can be inferred that the data used for verification and validation would be MRI Diffusion Weighted Images (DWI), but details on origin (e.g., country, specific institutions) or whether it was retrospective/prospective are not provided.

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 in the document. The general statement is that the application is "to be used by trained professionals including but not limited to physicians and medical technicians." This refers to the end-users, not necessarily experts establishing ground truth for testing.

4. Adjudication method for the test set:

This information is not provided in the document.

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, an MRMC comparative effectiveness study was not done or reported. The document explicitly states: "The subject of this premarket submission, Advanced Diffusion Analysis (ADA) application did not require clinical studies to support equivalence." This indicates that studies involving human readers, with or without AI assistance, were not part of this 510(k) submission. The focus was on demonstrating substantial equivalence to a predicate device.

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

The document implies that standalone performance was evaluated during the "Verification and Validation (V&V) activities." The detailed results of this standalone performance, in terms of specific metrics, are not provided, only a general statement that it "meets all defined functionality requirements and performance claims." The device is a "post-processing software application," suggesting an algorithm-only function that generates parametric maps and images for trained professionals to interpret.

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

This information is not explicitly stated in the document. Given that the device analyzes Diffusion Weighted Images and outputs parametric maps, the "ground truth" during V&V would likely involve comparisons against established quantitative methods or expert review of the generated maps, but the specifics are absent.

8. The sample size for the training set:

This information is not provided in the document. The document describes V&V activities, which typically involve testing, not training. If machine learning was used implicitly, no details on training data are given.

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

This information is not provided in the document, as details on a training set itself are absent.

Summary

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December 12, 2017

Philips Medical Systems Nederland B.V. % Yoram Levy Qsite General Manager Osite 31 Haavoda Street Binyamina 30500 ISRAEL

Re: K173467

Trade/Device Name: Advanced Diffusion Analysis (ADA) application Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 2, 2017 Received: November 8, 2017

Dear Yoram Levy:

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara
For

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

Enclosure

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Indications for Use

510(k) Number (if known) K173467

Device Name

Advanced Diffusion Analysis (ADA) application

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(K) SUMMARY

Advanced Diffusion Analysis (ADA) application

Date prepared:

November 2, 2017

I. Submitter's name and address

Establishment name:	Philips Medical Systems Nederland B.V.
Establishment address:	Veenpluis 4-65684 PC BestThe Netherlands
Establishment registration:	3003768277
Primary Contact person:	Yoram Levy, QsiteQA/RA Consultant31 Haavoda StreetBinyamina, Israel 30500Tel (972)4-638-8837;Fax (972)4-638-0510Yoram@qsitemed.com
Alternative contact person	Anat HerschRegulatory Affairs Lead, ICAPPhilips Medical Systems Nederland B.VE-mail: anat.hersch@philips.com
II. Device information
Trade name:	Advanced Diffusion Analysis (ADA)
Device Classification Name	System, Image processing, Radiological
Device Class	Class II
Classification Panel	LLZ
Product Code	Radiological Image Processing Software
Regulation Description	21 CFR 892.2050

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III. Device Description:

The physician retains the ultimate responsibility for making the final diagnosis.

Key Features

ADA application has the following key features:

1. Support visualization and processing of isotropic diffusion-weighted MRI data.
1. Calculate and display a computed Diffusion Weighted Image (cDWI) at a b-value of choice.
1. Support input image registration in a pre-processing step.
1. Present a default analysis model based on the available original DWI images and provide a selection of alternative available models.
1. Provide diffusion analysis models, as well as parametric maps of Perfusion fraction (f), Pseudo Diffusion coefficient (D*), Diffusion coefficient (D) and Kurtosis (K).
1. Provide a 'Goodness of fit' map, 'Goodness of fit' value and fitted curve showing the fitting quality of the selected model.
1. Display parameter values from user defined ROI's (Regions of Interest).
1. Display the ROI results in tabular and graphical formats.
1. Support export of the parametric maps as grayscale or RGB images for visualization in other viewers or PACS systems.

[V. Intended use:

The Philips Medical Systems' Advanced Diffusion Analysis

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Advanced Diffusion Analysis (ADA) application– Traditional 510k Submission

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(ADA) application is a post processing software application to be used by trained professionals including but not limited to physicians and medical technicians. The Philips Medical Systems' Advanced Diffusion Analysis (ADA) application can be used to perform image viewing, process and analysis of MRI Diffusion Weighted Images (DWI).

V. Predicate Devices:

The Advanced Diffusion Analysis (ADA) application is substantially equivalent to the following market-cleared devices:

Table 2-1 Predicates table

	Device Name	Manufacturer	510k No	Date ofClearance
Primarypredicate	Olea Sphere V3.0	Olea Medical	K152602	March 3, 2016

The proposed Philips Medical Systems Advanced Diffusion Analysis (ADA) application and its predicate device, Olea Sphere V3.0 (K152602) are substantially equivalent in regards to their intended uses, clinical indications, principle of operation and fundamental technology principles.

VI. Substantial Equivalence to Predicate Devices

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Feature	The proposed device:Advanced Diffusion	Primary Predicate:Olea Sphere V3.0
	Analysis (ADA) application	(K152602)
Device	System, Image processing,	System, Image processing,
ClassificationName	Radiological	Radiological
Device Class	Class II	Class II
ClassificationPanel	Radiology	Radiology
Product Code	LLZ	LLZ
Regulation	Picture Archiving and	Picture Archiving and
Description	communication system	communication system
RegulationNumber	21 CFR 892.2050	21 CFR 892.2050
Indication forUse	The Philips Medical Systems'Advanced Diffusion Analysis(ADA) application is a postprocessing softwareapplication to be used bytrained professionalsincluding but not limited tophysicians and medicaltechnicians. The PhilipsMedical Systems' AdvancedDiffusion Analysis (ADA)application can be used toperform image viewing,processing and analysis ofMRI Diffusion WeightedImages (DWI).	Olea Sphere V3.0 is an imageprocessing software package to beused by trained professionalsincluding, but not limited to,physicians and medicaltechnicians. The software runs on astandard "off-the-shelf" workstationandcan be used to perform imageviewing, processing, image collageand analysis of medical images.Data and images are acquiredthrough DICOM compliant imagingdevices and modalities. OleaSphereV3.0 provides both viewingand analysis capabilities offunctional and dynamic imagingdatasets acquired with MRI orother relevant modalities,including a Diffusion WeightedMRI (DWI) / Fiber TrackingModule and a Dynamic AnalysisModule (e.g., dynamic exogenousorendogenous contrast enhancedimaging data for MRI and CT).The DWI Module is used tovisualize local water diffusion
		properties from the analysis of diffusion-weighted MRI data. The Fiber Tracking feature utilizes the directional dependency of the diffusion to display the white matter structure in the brain or more generally the central nervous system. The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast while repeating acquisitions (e.g., over time with or without variable acquisition parameters) where such techniques are useful or necessary. This functionality is referred to as: Perfusion Module – the calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Permeability Module – the calculation of parameters related to leakage of injected contrast material from intravascular to extracellular space. Arterial Spin Labeling (ASL) Module – the calculation of parameters related to tissue flow based on a MR technique using the water in arterial blood as endogenous tracer to evaluate the perfusion. Relaxometry Module – the calculation of parameters related to the MR longitudinal and transversal relaxation time and rate. Metabolic Module – the calculation of parameters related to the fat signal fraction based on a MR technique using opposed-phase imaging
Intended users	Trained professionals including but not limited to physicians and medical technicians.	Trained professionals including but not limited to physicians and medical technicians.
Intended Body part	All body	All body
Type of scans	Diffusion MRI scans	Multi-Modality support: CT ,MRI PET/CT and SPECT/CT.The DWI Module is for Diffusion MRI scans
VisualizationMRI datacapabilities	YesSupports visualization andprocessing of isotropicdiffusion-weighted MRI data	YesSupports visualization and processisotropic diffusion-weighted MRIdata
Display imagescapabilities	YesDisplay images acquired atdifferent diffusion gradientfactors (b-values)	YesDisplay images acquired at differentdiffusion gradient factors (b-values)
ImageRegistration	Yes	Yes
ComputedDiffusionWeighted Image(cDWI)	YesCalculate and display acomputed Diffusion WeightedImage (cDWI) at a b-value ofchoice.	YesCalculate and display a computedDiffusion Weighted Image (cDWI)at a b-value of choice.
Computedsimple ADCDiffusion maps	Yes	Yes
Differentdiffusion models	YesThe application suggests aselection of diffusion models.	Yes
Region ofInterest	YesThe user can select and drawthe Region of Interest	YesThe user can select and draw theRegion of Interest
Computation ofPseudo-diffusioncoefficient (D*)parametric map	Yes	Yes
Computation ofdiffusioncoefficient (D)parametric map	Yes	Yes
Computation ofperfusionfraction (f)parametric map	Yes	Yes
Computation ofKurtosis (K)parametric map	Yes	Yes
Computation ofgoodness of fitparametric map	YesProvide a ‘Goodness of fit’map, ‘Goodness of fit’ valueand fitted curve showing thefitting quality of the selectedmodel.	No
Result	Display results in tabular andgraphical format	Display results in tabular andgraphical format
Export imageOption	Yes	Yes
DICOM formatcommunication	Yes	Yes

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The Philips Medical Systems Advanced Diffusion Analysis (ADA) and the identified predicate Olea Sphere V3.0 (K152602) are substantially equivalent in terms of indications for use and intended users, design features, principle of operation and fundamental scientific technology, and safety and/or effectiveness.

In conclusion, Philips believes that the Advanced Diffusion Analysis (ADA) does not introduce any new potential safety and/or effectiveness issues and is substantially equivalent to the identified predicate devices, Olea Sphere V3.0 (K152602).

VII. Brief discussion of the nonclinical tests submitted, referenced or relied on

Non-clinical performance testing has been performed on ADA and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:

ISO 14971 Medical devices Application of risk management to medical devices
IEC 62304 Medical device software Software life cycle processes
Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

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NEMA PS 3.1-3.20 standard Digital Imaging and Communications in Medicine (DICOM) Standard
Philips Medical Systems Advanced Diffusion Analysis (ADA) application was tested in accordance with Philips verification and validation processes. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications and the risk management results.

The test results in this 510(k) premarket notification demonstrate that Advanced Diffusion

Analysis (ADA)

Complies with the aforementioned international and FDA-recognized consensus . standards and FDA guidance document, and
Meets the acceptance criteria and is adequate for its intended use and specifications. .

VIII. Brief discussion of clinical tests submitted, referenced or relied on

The subject of this premarket submission, Advanced Diffusion Analysis (ADA) application did not require clinical studies to support equivalence.

IX. The conclusions drawn from the nonclinical and clinical tests

Verification and Validation (V&V) activities required to establish performance and functionality of Advanced Diffusion Analysis (ADA) were performed. Testing performed demonstrated the Advanced Diffusion Analysis (ADA) meets all defined functionality requirements and performance claims.

X. Overall conclusion:

The Advanced Diffusion Analysis (ADA) is substantially equivalent to the identified predicate device, Olea Sphere V3.0 (K152602) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Additionally, verification and validation testing demonstrate the safety and efficacy of the device to meet its intended use and specifications.

Philips Medical believes that the proposed device, Advanced Diffusion Analysis (ADA)

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application, is substantially equivalent to its identified predicate device and is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).