The AAA Model is a software application designed to view and quantify 3D image data acquired by Philips diagnostic ultrasound systems for use in measuring the anterior diameter of abdominal aortic aneurysms. Optionally, lateral diameter, maximum diameter, and partial volume of an abdominal aortic aneurysm can also be provided. It is intended to be used by trained and qualified healthcare professionals in clinical point-of-care facilities.

Device Description

AAA Model for QLAB Advanced Quantification Software is a software application designed for structural measurements of an Abdominal Aortic Aneurism (AAA), including volume measurement and diameter measurements. AAA Model is designed to assist in monitoring a previously diagnosed Abdominal Aortic Aneurisms in two ways:

to follow the anteroposterior (AP) maximum diameter for a Native AAA, and
to follow the anteroposterior (AP) maximum diameter for a post-surgical AAA.
Philips QLAB Advanced Quantification Software (QLAB) is designed to view and quantify image data acquired on Philips ultrasound systems. QLAB is available either as a stand-alone product that can function on a standard PC, a dedicated workstation, and on-board Philips' ultrasound systems. AAA Model is compatible with the Philips EPIQ Diagnostic Ultrasound System.

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the Philips AAA Model, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria	Reported Device Performance
Bench Testing
Measurement Accuracy Verification (Volume)	± 9% accuracy for volume measurement, with 90% confidence interval.	"All measurements met the acceptance criteria."
Measurement Accuracy Verification (Diameter)	± 5% accuracy for all diameter measurements (AP/LAT/MAD), with 90% confidence interval.	"All measurements met the acceptance criteria."
Clinical Testing
Native AAA Clinical Evaluation	At least 80% of all cases in which Philips AAA Model provides maximum AP diameter results that match standard of care 2D ultrasound measurements to within ± 10%.	"Result met the target successful rate." (This implies the 80% with ±10% agreement was achieved).
Post-EVAR AAA Clinical Evaluation	At least 80% of all cases in which Philips AAA Model provides maximum AP diameter results that match standard of care 2D ultrasound measurements to within ± 10%.	"Result met the target successful rate." (This implies the 80% with ±10% agreement was achieved).

2. Sample Sizes Used for the Test Set and Data Provenance

Bench Testing:
- Sample Size: 7 samples were used for each measurement (volume, AP diameter, LAT diameter, MAD diameter).
- Data Provenance: The data was generated using "EPIQ diagnostic ultrasound system...to take 3D ultrasound images of 3 phantoms with various diameter." This indicates a controlled, simulated environment (phantom study).
Clinical Testing:
- Native AAA:
  - Sample Size: 91 datasets (from an initial 129 gathered) met the inclusion criteria.
  - Data Provenance: "129 Native AAA datasets were gathered from one hospital in Copenhagen, Denmark. ... All patients age > 18 years old." This indicates prospective or retrospective clinical data from Denmark.
- Post-EVAR AAA:
  - Sample Size: 45 datasets (from an initial 77 gathered) met the inclusion criteria.
  - Data Provenance: "77 Post-EVAR AAA datasets were gathered from one hospital in Copenhagen, Denmark. ... All patients age > 18 years old." This indicates prospective or retrospective clinical data from Denmark.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience").

For clinical testing, the "standard of care 2D ultrasound measurement" is used as the ground truth. It is implied that these measurements would have been performed by qualified healthcare professionals (e.g., sonographers or physicians) at the hospital in Copenhagen, Denmark, as part of routine clinical practice.

4. Adjudication Method for the Test Set

The document does not explicitly describe a formal adjudication method (like 2+1 or 3+1) for establishing ground truth in either the bench testing or clinical testing.

For bench testing, the ground truth is derived from the known dimensions of the phantoms.
For clinical testing, the "standard of care 2D ultrasound measurement" is considered the reference. It is not specified if multiple readers were used for these reference measurements or if any discrepancies were adjudicated.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compared the device's measurements to a "standard of care 2D ultrasound measurement," but it was not designed to evaluate the improvement of human readers with AI assistance versus without. The device itself is described as "not a computer-assisted detection (CADe) device, and does not use artificial intelligence or machine learning."

6. Standalone Performance Study

Yes, a standalone performance study was done. The device's performance was evaluated by directly comparing its measurements (AP diameter, volume, etc.) against established ground truth (phantom measurements for bench testing, standard of care 2D ultrasound measurements for clinical testing). The description implies that the AAA Model was used as an independent tool to quantify the images.

7. Type of Ground Truth Used

Bench Testing: Physical dimensions of phantoms (a known, manufactured standard).
Clinical Testing: "Standard of care 2D ultrasound measurement" for abdominal aortic aneurysm AP diameter.

8. Sample Size for the Training Set

The document does not provide information regarding a separate training set or its sample size. The device is explicitly stated as "not a computer-assisted detection (CADe) device, and does not use artificial intelligence or machine learning," which suggests it may not have a traditional 'training set' in the context of machine learning. Its functionality seems to be based on pre-programmed algorithms for structural measurements rather than learned patterns from a training dataset.

9. How Ground Truth for the Training Set Was Established

As noted in point 8, the document does not mention a training set for the AAA Model, given its description as not using AI/ML. Therefore, the method for establishing ground truth for a training set is not applicable or provided.

Summary

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September 20, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.

Philips Ultrasound, Inc. % Hebe Sun Regulatory Affairs Manager 22100 Bothell Everett Highway BOTHELL WA 98021

Re: K200603

Trade/Device Name: AAA Model Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: August 12, 2020 Received: August 17, 2020

Dear Hebe Sun:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200603

Device Name AAA Model

Indications for Use (Describe)

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)

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510(k) Summary

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THIS SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

IS SUBMITTED IN ACCORDANCE WITH 21CFR § 807.92

1. Submitter's name, address, telephone number, contact person.

Philips Ultrasound, Inc. 22100 Bothell Everett Hwy Bothell, WA 98021-8431

Contact:	Hebe Sun
Title:	Sr. Regulatory Affairs Manager
Email:	hebe.sun@philips.com
Tel:	425-219-1223
Fax:	425-487-8666
Date prepared:	Aug 11, 2020

1. Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known.
  Common name: Picture archiving and communications system

Proprietary name: AAA Model

Regulation Number: 21 CFR 892.2050

Classification name: System, Image Processing, Radiological

Product code: LLZ,

Class II Classification:

3. Indications for Use

The AAA Model is a software application designed to view and quantify 3D image data acquired by Philips diagnostic ultrasound systems for use in measuring the anterior-posterior diameter of abdominal aortic aneurysms. Optionally, lateral diameter, maximum diameter, and partial volume of an abdominal aortic aneurysm can also be provided. It is intended to be used by trained and qualified healthcare professionals in clinics, hospitals, and clinical point-of-care facilities.

Device Description 4.

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1. to follow the anteroposterior (AP) maximum diameter for a Native AAA, and
1. to follow the anteroposterior (AP) maximum diameter for a post-surgical AAA.

AAA model is not a computer-assisted detection (CADe) device, and does not use artificial intelligence or machine learning.

Philips QLAB Advanced Quantification Software (QLAB) is designed to view and quantify image data acquired on Philips ultrasound systems. QLAB is available either as a stand-alone product that can function on a standard PC, a dedicated workstation, and on-board Philips' ultrasound systems. AAA Model is compatible with the Philips EPIQ Diagnostic Ultrasound System.

5. Substantially Equivalent Devices

Primary Predicate Device
GI-3DQ in QLAB Advanced Quantification Software	K200974
Reference Device
VPO in QLAB Advanced Quantification Software	K121223

A comparison of technical characteristics for subject device and the currently marketed predicate device is provided on the following table.

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Traditional 510(k)

AAA Model K200603

Comparison of Technical Characteristics

	Primary Predicate	Reference Device	Subject Device	Explanation of Differences
Trade Name	QLAB System	QLAB System	QLAB System	N/A
Feature	GI-3DQ	VPQ	AAA Model	N/A
510(k) number	K200974	K121223	K200603	N/A
Product Code	QIH	LLZ	LLZ	Identical
RegulationNumber andRegulationName	21 CFR 892.2050;System, Image processing,RadiologicalPicture Archiving andCommunications System(PACS)	21 CFR 892.2050;System, Imageprocessing, RadiologicalPicture Archiving andCommunications System(PACS)	21 CFR 892.2050;System, Imageprocessing, RadiologicalPicture Archiving andCommunications System(PACS)	Identical
Indication forUse	Philips QLABQuantification softwareapplication package isdesigned to view andquantify image dataacquired on Philipsultrasound products	Philips QLABQuantificationsoftwareapplication package isdesigned to view andquantify image dataacquired on Philipsultrasound products.The Vascular PlaqueQuantification (VPQ)plug-in providesprotocol driven tools	Philips QLABQuantificationsoftwareapplication package isdesigned to view andquantify image dataacquired on Philipsultrasound products.The AAA Model is asoftware applicationdesigned to view andquantify 3D image data	The primary predicate GI-3DQ in QLAB is intended tobe used for computing 3Dmeasurements for anyregions of interest, which canbe used in the situation ofabdominal aortic aneurysm.The subject device, AAAmodel application in QLAB,is designed to measurediameter of a previouslydetected abdominal aorticaneurysm.
	Primary Predicate	Reference Device	Subject Device	Explanation of Differences
Trade Name	QLAB System	QLAB System	QLAB System	N/A
Feature	GI-3DQ	VPQ	AAA Model	N/A
510(k) number	K200974	K121223	K200603	N/A
		for performing a semi-automated analysis ofplaques in the carotidartery.	acquired by Philips EPIQDiagnostic ultrasoundsystems for use inmeasuring Anterio-posterior diameter.Optionally, Lateraldiameter, Maximumdiameter, and partialvolume of theAbdominal AortaAneurysm can also beprovided. It is intendedto be used by trained andqualified healthcareprofessionals in clinics,hospitals, and clinicalpoint-of-care facilities.
	Primary Predicate	Reference Device	Subject Device	Explanation of Differences
Trade Name	QLAB System	QLAB System	QLAB System	N/A
Feature	GI-3DQ	VPQ	AAA Model	N/A
510(k) number	K200974	K121223	K200603	N/A
Applicationdescription	GI-3DQ computes linearmeasurements, areameasurements, stackedcontour volumemeasurements, andellipsoid volumemeasurements, of anyregions of interest thatusers select.	VPQ provides semi-automatic analysis ofplaque in the carotidartery. it calculatesplaque and lumen areas,and also the percentreduction for eachtracked frame.	AAA generates semi-automatic structuralmeasurements ofabdominal aorticaneurysm, includingvolume and diametermeasurements.	Predicate GI-3DQ is forgeneral imaging analysis ofany regions of interest, whilesubject device AAA isspecifically designed forabdominal aortic aneurysmanalysis. The impact of thedifference in clinicalapplication on device safetyand effectiveness isaddressed by the clinicalperformance study.
ContourGeneration	Borders are createdmanually to create a 3Dmodel.	Preliminary borders and3D model are createdautomatically withoutuser interaction.User is required to edit,accept or reject thecontours.	Preliminary borders and3D model are createdautomatically withoutuser interaction.User is required to edit,accept or reject thecontours prior to 3Dvolume and diametermeasurements.	Subject device AAA semi-automated border detectionfunction is equivalent toVPQ. User is required toaccept border prior tocalculation for all apps.
	Primary Predicate	Reference Device	Subject Device	Explanation of Differences
Trade Name	QLAB System	QLAB System	QLAB System	N/A
Feature	GI-3DQ	VPQ	AAA Model	N/A
510(k) number	K200974	K121223	K200603	N/A
QuantificationTechnology	Manual border tracingover multiple slices;Creates 3D mesh to derivevolume measurement;diameter measurementdone via manual distancemeasurement tool	Automated preliminaryborder detection;Creates 3D mesh toderive volumemeasurement; diametermeasurement done viamanual distancemeasurement tool	Automated preliminaryborder detection; creates3D mesh andauto-segmentation ofAAA to derive volumeand diametermeasurements oncepreliminary borders areconfirmed by user	Both subject device andpredicate create 3D mesh toderive volume measurement.The difference is predicateGI-3DQ use manual distancemeasurement tool fordiameter measurement, whilethe subject device AAA canderive the diametermeasurements from the 3Dmesh and auto-segmentationof the 3D model. The impactof the difference on safetyand effectiveness isaddressed by themeasurement accuracy testfrom bench performancetesting
	MeasurementParameters	This app computeslinear measurements, areameasurements, stackedcontour volumemeasurements, and	This app calculatesplaque and lumen areas,and also the percentreduction for eachtracked frame.	AAA model providesMax Anteroposterior(AP) diameter, MaxLateral Diameter (LAT),Max any direction	The measurements functionof AAA model, including thediameter measurement andvolume measurement, issimilar to GI3DQ.
			Primary Predicate	Reference Device	Subject Device	Explanation of Differences
		Trade Name	QLAB System	QLAB System	QLAB System	N/A
		Feature	GI-3DQ	VPQ	AAA Model	N/A
		510(k) number	K200974	K121223	K200603	N/A
		ellipsoid volumemeasurements.		(MAD) diameter, andpartial volumemeasurement.

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Traditional 510(k)
AAA Model K200603

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6. Nonclinical Performance Data

AAA Model was tested in accordance with Philips internal processes. Non-Clinical verification testing has been performed addressing system level requirements according to system and design specifications, and risk control measures. Software verification and clinical performance accuracy data were used to support substantial equivalence of the AAA Model application to the predicate QLAB Advanced Quantification Software applications.

BenchTesting	Test Method	Sample	AcceptanceCriteria	Result
MeasurementAccuracyVerification	EPIQ diagnosticultrasoundsystem was usedto take 3Dultrasoundimages of 3phantoms withvarious diameter.AAA model wasused to measuretheAP/LAT/MADdiameter andpartial volume.	7 samples wereused for eachmeasurement.	± 9% accuracyfor volumemeasurement and± 5% for alldiametermeasurements,with 90%confidenceinterval.	Allmeasurementsmet theacceptancecriteria.

7. Clinical testing

Clinical performance evaluation study showed that the aneurysm AP diameter measurement from AAA model is in agreement with the measurement from 2D ultrasound as the current standard of care, which supports that the performance of AAA model is appropriate for its intended use of AP diameter measurement for the evaluation of abdominal aorta aneurysm.

Clinical testing	Test Method	Sample	Acceptance Criteria	Result
Native AAA clinical evaluation	Native AAA ultrasound images were acquired during normal ultrasound examination in hospital. AP diameter from	129 Native AAA datasets were gathered from one hospital in Copenhagen, Denmark. 91 of the exams met the inclusion criteria. All	At least 80% of all cases in which Philips AAA Model provides maximum AP diameter results that match standard of care	Result met the target successful rate.

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Traditional 510(k) AAA Model K200603

Clinical testing	Test Method	Sample	AcceptanceCriteria	Result
	2D ultrasoundmeasurement,and from 3Dultrasoundmeasurementwith AAAmodel arecompared.	patients age> 18years old.	measurements towithin ± 10%
Post -EVARAAA clinicalevaluation	Post-EVARAAA ultrasoundimages wereacquired duringnormalultrasoundexamination inhospital. APdiameter from2D ultrasoundmeasurement,and from 3Dultrasoundmeasurementwith AAAmodel arecompared.	77 Post-EVARAAA datasetswere gatheredfrom onehospital inCopenhagen,Denmark. 45 ofthe exams metthe inclusioncriteria. Allpatients age> 18years old.	At least 80% ofall cases inwhich PhilipsAAA Modelprovidesmaximum APdiameter resultsthat matchstandard of caremeasurements towithin ± 10%	Result met thetargetsuccessful rate.

8. Sterilization

Not applicable. This is a software only device.

9. Conclusion

For testing, all pre-determined acceptance criteria were met. Results of these tests show that the proposed AAA Model meets the intended use. The differences between the subject device and predicate device do not raise new questions of safety and/or effectiveness. Therefore, the proposed AAA Model is substantially equivalent to the predicate QLAB Advanced Quantification Software applications in terms of intended use, technological characteristics, safety and effectiveness.

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).