QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems.

Device Description

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.

The subject QLAB 3D Auto RV application integrates the segmentation engine of the cleared QLAB HeartModel (K181264) and the TomTec-Arena 4D RV-function (cleared under K150122) thereby providing a dynamic Right Ventricle clinical functionality. The proposed 3D Auto RV application is based on the automatic segmentation technology of HeartModel applied to the Right Ventricle, and uses machine learning algorithms to identify the endocardial contours of the Right Ventricle.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the QLAB Advanced Quantification Software 13.0, specifically for its 3D Auto RV application:

1. Table of Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria	Reported Device Performance (3D Auto RV vs. predicate 4D RV)	Reported Device Performance (3D Auto RV vs. CMR)
RV End Diastolic Volume Error Rate	Below 15% (compared to predicate)	Below 15%	Less than 15% difference
RV End Diastolic Volume (RMSE)	Not explicitly stated as an independent acceptance criterion, but part of validation.	8.3 ml RMSE	Not explicitly reported for this metric
RV End Systolic Volume (RMSE)	Not explicitly stated as an independent acceptance criterion, but part of validation.	2.7 ml RMSE	Not explicitly reported for this metric
RV Ejection Fraction (RMSE)	Not explicitly stated as an independent acceptance criterion, but part of validation.	2.7% RMSE	Not explicitly reported for this metric
User Ability to Discern and Revise	Healthcare professional able to successfully determine when contours require revision and capable of revising.	Users were able to discern which images needed manual editing on all cases.	Not explicitly reported for this metric
Accuracy and Reproducibility (External Study)	Not explicitly stated as a numerical acceptance criterion, but "accurate and highly reproducible"	Accurate and highly reproducible. No revision needed in 1/3 of patients, minor revisions in the rest.	Less than 15% difference (for RV volume)

2. Sample Size and Data Provenance

Test Set Sample Size: Not explicitly stated for either the internal validation study or the external published study.
Data Provenance:
- Internal Validation Study: "Test datasets were segregated from training data sets." No explicit country of origin is mentioned. It is implied to be retrospective as it uses "data sets."
- External Published Study: Not specified, but it's an "external study published in the Journal of the American Society of Echocardiography."

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Internal Validation Study: Not specified. However, the comparison is primarily against a "predicate 4D RV" which would have its own established methodology. The "healthcare professional" is mentioned in the context of user evaluation.
External Published Study: Not specified. The ground truth method is cross-modality CMR, implying a reference standard rather than expert consensus on the test images themselves.

4. Adjudication Method (Test Set)

Internal Validation Study: Not explicitly stated. The comparison is against the predicate device's measurements.
External Published Study: Not explicitly stated. Ground truth was established by cross-modality Cardiac Magnetic Resonance (CMR).

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

The document does not explicitly describe a formal MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The text mentions that "the healthcare professional was able to successfully determine which contours required revision and was capable of revising," which suggests a human-in-the-loop scenario, but a comparative effectiveness study with effect size is not reported.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation of the algorithm is implied. The internal validation study reports "RV end diastolic volume error rates below 15% for every data set tested compared to the predicate 4D RV," and RMSE values for volume and EF. The external study also reports the 3D Auto RV's performance against CMR. While user interaction for editing is a feature, the initial segmentation engine and its quantification are evaluated in a standalone manner before potential revision.

7. Type of Ground Truth Used

Internal Validation Study: The primary comparison for quantitative metrics (volumes, EF) is against the "predicate 4D RV" (TomTec-Arena 4D RV-function, K150122). This suggests the predicate's measurements served as a reference.
External Published Study: Cross-modality Cardiac Magnetic Resonance (CMR) was considered the gold standard ("Ground truth in this study was considered to be the cross-modality CMR").

8. Sample Size for the Training Set

Not explicitly stated for the machine learning algorithm. The document only mentions that "Test datasets were segregated from training data sets."

9. How Ground Truth for the Training Set Was Established

Not explicitly detailed. The device description states the 3D Auto RV application "uses machine learning algorithms to identify the endocardial contours of the Right Ventricle." It also mentions "Algorithm Training procedure is same between the subject and the predicate HeartModel." For HeartModel (the segmentation engine's predecessor for LV), expert-defined contours on extensive datasets would typically be used for training, but this is not explicitly stated for the RV training.

Summary

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Philips Healthcare Eri Gremi Philips Ultrasound Inc. 3000 Minuteman Road Andover, MA 01810-6302

Re: K191647

Trade/Device Name: QLAB Advanced Quantification Software 13.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: QIH Dated: November 22, 2019 Received: November 25, 2019

Dear Eri Gremi:

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for

December 20, 2019

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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 mediation-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) K191647

Device Name

QLAB Advanced Quantification Software 13.0

Indications for Use (Describe)

QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems.

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

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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness is provided as part of the Premarket Notification in compliance with 21CFR. Part 807, Subpart E, Section 807.92

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

Primary Contact:	Eri Gremi
	Philips Ultrasound, Inc.
	3000 Minuteman Road
	Andover, MA 01810-6302
	Email: erdit.gremi@philips.com
	Tel: (978) 659-2980
	Fax: (978) 975-7324

Date prepared: November 22 2019

Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

Common/Usual Name:	Picture archiving and communications system
Proprietary Name:	QLAB Advanced Quantification Software 13.0
Classification Name:	21 CFR 892.2050, System, Image Processing,Radiological,
Product code:	QIH, Class II

Substantially Equivalent Devices

Primary Predicate Device
QLAB Advanced Quantification Software	K181264	June 7, 2018
Reference Device
TomTec-Arena TTA2	K150122	February 13, 2015

Philips Ultrasound believes that the QLAB 13.0 modifications which are the subject of this 510(k) are substantially equivalent to QLAB K181264.

Device Description

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Indications for Use

QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems.

Technological comparison to predicate devices

The QLAB Advanced Quantification software with the modified Q-Apps has the same intended use and technological characteristics as the legally marketed predicate devices. A comparison of the proposed OLAB 3D Auto RV application to the currently marketed predicate device (QLAB) and reference device (TomTec-Arena TTA2) are provided in the tables below:

Feature	Currently MarketedPredicate QLAB(Predicate Device -K181264)	Currently MarketedReference TomTec-ArenaTTA2(Reference Device -K150122)	Proposed QLAB 3DAuto RV(Modified Device)	Explanation ofDifferences
Indicationfor Use	QLAB Quantificationsoftware is a softwareapplication package.It is designed to viewand quantify imagedata acquired onPhilips ultrasoundsystems.	Indications for use ofTomTec-Arena TTA2software are quantificationand reporting ofcardiovascular, fetal,abdominal structures andfunction of patients withsuspected disease tosupport the physicians inthe diagnosis	Same as QLAB(K181264)	Not applicable

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	Philips Ultrasound, Inc.
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Traditional 510(k) QLAB Advanced Quantification Software

Feature	Currently MarketedPredicate QLABHeartModel (K181264)	Currently MarketedReference TomTec-Arena TTA2 4D RV(Reference Device -K150122)	Proposed QLAB 3DAuto RV (ModifiedDevice)	Explanation ofDifferences
Applicationdescription	The HeartModel providessemi-automatic 3Danatomical borderdetection andidentification of the heartchambers for the end-diastole (ED) and end-systole (ES) cardiacphases.	The TOMTECARENA 4D RV-Function provides amorphological andfunctional assessmentof the right ventriclebased on a surfacemodel of the RV.	The 3D Auto RV Q-Appis an integration of thesegmentation engine ofthe QLAB HeartModeland the TomTec-Arena4D RV-Function therebyproviding a dynamicRight Ventricle clinicalfunctionality.	Integrates HeartModelauto-segmentationtechnology withTomTec Arena's 4D-RV algorithm for RVborder placement.
QuantificationTechnology ofRV	Semi-automatic borderdetection andidentification of LV andLA chambers	Functional assessmentof RV based on a RVsurface model.	Integrates HeartModelauto-segmentationtechnology with TomTecArena's 4D-RValgorithm for RV borderplacement	Anatomicalenhancement by RightVentricle
2D RVmeasurementparameters	No RV parameters	■ RVDd base (RVD1):Right VentricleDistance base (mm)■ RVDd mid (RVD2):Right VentricleDistance medial(mm)■ RVLd (RVD3): RightVentricle DistanceLongitudinal (mm)■ TAPSE: Tricuspidannular plane systolicexcursion (mm)■ FAC: Fractional areachange (%)■ RVLS (free wall):right ventricularlongitudinal strain(free wall) (%)■ RVLS(Septum): rightventricularlongitudinal strain(septum) (%)	■ RVDd base (RVD1):Right VentricleDistance base (mm)■ RVDd mid (RVD2):Right VentricleDistance medial (mm)■ RVLd (RVD3): RightVentricle DistanceLongitudinal (mm)■ TAPSE: Tricuspidannular plane systolicexcursion (mm)■ FAC: Fractional areachange (%)■ RVLS (free wall): rightventricular longitudinalstrain (free wall) (%)■ RVLS (Septum): rightventricular longitudinalstrain (septum) (%)	Identical to 4D RVpredicate
2D RVcalculatedparameters	No RV parameters	■ Global strain■ TAPSE: MModemeasurement formovement of TV	■ Global strain■ TAPSE: MModemeasurement formovement of TV	Identical to 4D RVpredicate

3D RVmeasurementparameters	No RV parameters	■ RV distancemeasurements: 3distancemeasurements in theRV A4C in ED.■ RVD1: maximalshort-axis dimensionin the basal one thirdof the right ventricle■ RVD2: distance ismeasured on 50% ofRVLd (RVD3) andparallel to the RVD1■ RVD3: base-apexlength■ Fractional areachange (FAC)	■ RV distancemeasurements: 3distance measurementsin the RV A4C in ED.■ RVD1: maximal short-axis dimension in thebasal one third of theright ventricle■ RVD2: distance ismeasured on 50% ofRVLd (RVD3) andparallel to the RVD1■ RVD3: base-apexlength■ Fractional area change(FAC)	EDV measurementincludes semi-automatic functionintroduced in3DAutoRV. All othermeasurements identicalto 4D RV predicate.
3D RVmeasurementparameters	No RV parameters	■ EDV: End-diastolicVolume■ EDVI: End-diastolicVolume Index■ ESV: End-systolicVolume■ ESVI: End-systolicVolume Index■ SV: Stroke Volume■ EF: Ejection Fraction	■ EDV: End-diastolicVolume■ EDVI: End-diastolicVolume Index■ ESV: End-systolicVolume■ ESVI: End-systolicVolume Index■ SV: Stroke Volume■ EF: Ejection Fraction	EDV measurementincludes semi-automatic functionintroduced in3DAutoRV. All othermeasurements identicalto 4D RV predicate.
3D RVcalculatedparameters	No RV parameters	■ EF: Ejection Fraction■ SV: Stroke Volume	■ EF: Ejection Fraction■ SV: Stroke Volume	Identical to 4D RVpredicate
ContourGeneration	3D surface model iscreated semi-automatically withoutuser interaction.User is required to edit,accept or reject thecontours	3D surface model iscreated based on userdefined anatomicallandmarks. User isable to edit the contourof the surface model.	3D surface model iscreated semi-automatically usingmachine learningalgorithms without userinteraction. User is ableto edit, accept or rejectthe contours or theanatomical landmarks.	Workflowimprovements for userconvenience.Algorithm Trainingprocedure is samebetween the subject andthe predicateHeartModel, exceptthat the algorithm isapplied to LV inHeartModel, while toRV in subject 3D autoRV.

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	Philips Ultrasound, Inc.
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7) Determination of Substantial Equivalence

Non-clinical performance data

The QLAB 13.0 modifications were tested in accordance with Philips internal processes. Verification and software validation data support the proposed modified QLAB 13.0 software relative to the currently marketed unmodified QLAB software.

Design Control activities to assure the safe and effective performance of the modified Q-Apps included but not limited to the following:

Requirements Review ●
. Design Review
. Risk Management
. Software Verification and Validation

Non-clinical V&V testing also included the Machine Learning Algorithm Training and the subsequent Validation Study performed for the proposed 3D Auto RV clinical applications.

Software Verification and Validation testing were used to support substantial equivalence of the modified QLAB 13.0 to the predicate device.

The results of a validation study show that the overall performance of the 3D Auto RV software generates RV end diastolic volume error rates below 15% for every data set tested compared to the predicate 4D RV. A root mean square error (RMSE) analysis showed that in comparison to the predicate 4D RV, 3D Auto RV measured end diastolic RV volumes with 8.3 ml RMSE, end systolic RV volumes with 2.7 ml RMSE, and RV ejection fraction with 2.7% RMSE. Test datasets were segregated from training data sets. The results of the validation show that when used as intended, the healthcare professional was able to successfully determine which contours required revision and was capable of revising in the "tracking revision" screen prior to accepting the measurements for a report to create accurate measurements of the RV volume.

An external study published in the Journal of the American Society of Echocardiography which concludes that 3D Auto RV provides an accurate and highly reproducible quantification not needing any revision in one-third of patients and needing only minor revisions in the rest of patients. The users were able to discern the patients images which needed manual editing on all cases. Ground truth in this study was considered to be the crossmodality CMR. 3D Auto RV results all showed less than 15% difference from the CMR measurements of RV volume.

Summary of Clinical Tests

No clinical testing conducted in support of substantial equivalence.

514 Performance Standards

There are no Sec. 514 performance standards for this device.

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Prescription Status

This is a prescription device. The prescription device statement appears in the labeling.

Sterilization

Not applicable. QLAB Advanced Quantification is a software only device.

8) Conclusions

Software Verification and Validation activities required to establish the performance, functionality, and reliability characteristics of the modified QLAB software with respect to the predicate were performed. Testing performed demonstrated that the proposed QLAB 13.0 Advanced Quantification Software meets defined requirements and performance claims. Therefore, Philips concludes that the subject device is substantially equivalent to the predicate in terms of 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).