(26 days)
QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips Healthcare Ultrasound systems.
Philips QLAB Advanced Quantification software (OLAB) is designed to view and quantify image data acquired on Philips ultrasound products. 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. It can be used for the off-line review and quantification of ultrasound studies.
QLAB software provides basic and advanced quantification capabilities across a family of PC and cart based platforms. QLAB software functions through Q-App modules, each of which provides specific capabilities.
The provided FDA 510(k) summary for Philips' QLAB Advanced Quantification Software (K171314) focuses on modifications to existing Q-Apps (a2DQ and aCMQ/CMQ Stress) and primarily addresses software verification and validation, rather than a clinical study establishing new acceptance criteria or device performance through a comparative effectiveness study.
Therefore, much of the requested information (such as specific performance metrics, sample sizes for test sets, expert qualifications, adjudication methods, and MRMC study details) is not explicitly detailed in this document in the typical format of a clinical performance study. The document emphasizes equivalence to a predicate device and internal testing.
However, based on the provided text, here's an attempt to answer the questions, highlighting where information is not available:
Acceptance Criteria and Device Performance Study Details
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria or a "reported device performance" in terms of clinical metrics (e.g., sensitivity, specificity, accuracy) from a comparative study. Instead, the acceptance is based on the device meeting its defined requirements and performance claims during internal software verification and validation.
Acceptance Criteria (Implied from the document): The modified QLAB a2DQ and aCMQ/CMQ Stress Q-Apps are safe and effective and introduce no new risks, meeting defined requirements and performance claims validated through internal processes.
Reported Device Performance:
- The modifications to the a2DQ and aCMQ/CMQ Stress Q-Apps were tested in accordance with Philips internal processes.
- Verification and software validation data support the proposed modified QLAB a2DQ/aCMQ/CMQ Stress software relative to the currently marketed unmodified QLAB software.
- Testing demonstrated that the proposed QLAB Advanced Quantification Software, with modified Q-Apps, meets defined requirements and performance claims.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "software verification and validation data," but does not provide details on the number of cases or images used in this testing.
- Data Provenance: Not specified. It only mentions "Philips internal processes" for testing. Specifics like country of origin or retrospective/prospective nature of data are not mentioned.
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 document focuses on software validation and does not detail an expert-based ground truth establishment process for a clinical test set.
4. Adjudication method for the test set
- This information is not provided, as the nature of the "test set" described is for software verification/validation rather than a clinical adjudication process.
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 multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in this document. The submission focuses on device equivalence and software modifications, not an assessment of human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies that "Software Verification and Validation testing" was performed for the algorithms. While it doesn't explicitly state "standalone performance study," the entire context of "software only device" and "modification to software application package" suggests that the functional testing would inherently be of the algorithm's performance. However, there are no specific performance metrics (e.g., accuracy, precision) reported for this standalone performance.
7. The type of ground truth used
- The document does not explicitly state the type of "ground truth" in a clinical sense (e.g., pathology, outcomes data, expert consensus). Given it's a software modification submission, the "ground truth" for validation would likely be based on established reference values or measurements within the existing QLAB system, against which the modified algorithms were compared for consistent and accurate computation in "Requirements Review," "Design Review," "Risk Management," and "Software Verification and Validation" activities.
8. The sample size for the training set
- Not applicable/Not specified. The document describes modifications to existing software ("QLAB builds upon a simple and thoroughly modular design"). It does not describe the development of a de novo AI algorithm that would typically involve a separate "training set." The focus is on the verification of modified functionalities within an existing proven system.
9. How the ground truth for the training set was established
- Not applicable/Not specified, as no training set for a new AI algorithm is discussed.
Summary of Document Focus:
This FDA 510(k) summary is for a software modification to an existing device (QLAB Advanced Quantification Software). The primary goal is to demonstrate "substantial equivalence" to a predicate device and to show that the modifications do not introduce new safety or effectiveness risks. The "study" referenced is internal software verification and validation, not a clinical trial or comparative effectiveness study. Therefore, the details requested for clinical performance metrics, reader studies, and explicit ground truth establishment for clinical data sets are largely absent from this particular type of submission.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 30, 2017
Philips Healthcare % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K171314
Trade/Device Name: OLAB Advanced Ouantification Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 3, 2017 Received: May 3, 2017
Dear Mr. Job:
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.
{1}------------------------------------------------
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.
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
K171314 Device Name QLAB Advanced Quantification Software
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 Healthcare Ultrasound systems.
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.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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
Penny Greco Philips Healthcare, Inc. Regulatory Affairs Specialist 3000 Minuteman Road Andover, MA 01810-6302 Tel: (508) 843-0282 Fax (978) 975-7324
Date prepared: April 3, 2017
- 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 |
| Classification Name: | 21 CFR 892.2050, system image processing, radiological,Product code LLZ, Class II |
- Substantially Equivalent Devices
| Primary Predicate Device | ||
|---|---|---|
| QLAB Modifications | K132165 | 08/09/2013 |
| Reference Device | ||
| QLAB Quantification Software with Heart Model | K130159 | 05/13/2013 |
Philips Ultrasound believes that the QLAB Q-App modifications which are the subject of this 510(k) are substantially equivalent to other OLAB applications.
4) Device Description
Philips QLAB Advanced Quantification software (OLAB) is designed to view and quantify image data acquired on Philips ultrasound products. 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. It can be used for the off-line review and quantification of ultrasound studies.
QLAB software provides basic and advanced quantification capabilities across a family of PC and cart based platforms. QLAB software functions through Q-App modules, each of which provides specific capabilities.
{4}------------------------------------------------
| Philips Ultrasound, Inc. | Traditional 510(k)QLAB Advanced Quantification SoftwareModifications | Page 2 of 3 |
|---|---|---|
| -------------------------- | ------------------------------------------------------------------------------ | ------------- |
QLAB builds upon a simple and thoroughly modular design to provide smaller, lower cost, and more easily leveraged products.
Philips Ultrasound is submitting this 510(k) to address modifications to the a2DQ and aCMO which include:
- . a2DQ and aCMQ (including CMQ Stress) enhancements
- o Flexible screen layout options within a2DO and aCMO
- O The addition of LA volume calculation to a2DQ as a licensed option
5) Intended Use
QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems.
6) Technological comparison to predicate devices
The QLAB Advanced Quantification software with the modified Q-Apps has the same technological characteristics as the legally marketed device.
| Proposed QLAB a2DQ/aCMQ | Currently Marketed PredicateQLAB 10.0 Modifications(a2DQ/aCMQ) K132165 | Explanation of Differences |
|---|---|---|
| The proposed a2DQ/aCMQ/CMQStress includes:• 6-segment ROI• Enhanced contour andspeckle tracking• New selections GLS andReginal Strainmeasurement | Current a2DQ/aCMQ/CMQ Stressinclude:• 7-segment ROI• Contour and speckletracking• Gives users peak strain orpeak systolic strain withoutmeasurement labeldifferentiation. | Reason for modified QLABa2DQ/aCMQ/CMQ Stressapplications is to better comply withthe recommendations ofASE/EACVI. |
| The proposed a2DQ Q-Appincludes the licensed LA option forLA volume measurements. | The current a2DQ Q-App does nothave the LA option | Reason for modified QLAB a2DQApplication: Measurement of LAfunction has been shown to providevaluable clinicalinformation. QLAB Heart Model(K130159/K132165) provides themeasurement of LA volume inaddition to LV volumes for 3Dimages. Adding LA volumemeasurements to a2DQ providesthis valuable information to thelarge percentage of customers whoonly do 2D imaging. |
| QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify |
image data acquired on Philips ultrasound systems. The modifications to the currently marketed QLAB aCMQ (including CMQ Stress) and a2DQ do not affect the safety and efficacy of the proposed QLAB Advanced Quantification with the modified the aCMQ/CMQ Stress and a2DQ applications.
{5}------------------------------------------------
7) Determination of Substantial Equivalence
Non-clinical performance data
No performance standards for PACS systems or components have been issued under the authority of Section 514. The a2DQ/aCMQ modifications were tested in accordance with Philips internal processes. Verification and software validation data support the proposed modified QLAB a2DQ/aCMQ/CMQ Stress 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 were not limited to:
- · Requirements Review
- Design Review
- · Risk Management
- · Software Verification and Validation
Software Verification and Validation testing concluded that the modifications to the QLAB a2DQ and aCMQ/CMQ Stress Q-Apps are safe and effective and introduce no new risks.
Summary of Clinical Tests
QLAB introduces no new indications for use, modes, features, or technologies relative to the predicate device (QLAB) that require clinical testing.
8) Conclusions
Software Verification and Validation activities required to establish the performance, functionality, and reliability characteristics of the modified QLAB Q-Apps with respect to the predicate were performed. Testing performed demonstrated that the proposed OLAB Advanced Quantification Software, with modified Q-Apps, meets defined requirements and performance claims.
514 Performance Standards
There are no Sec. 514 performance standards for this device.
Prescription Status
This is a prescription device. The prescription device statement appears in the labeling.
Sterilization Site(s)
Not applicable. QLAB Advanced Quantification is a software only device.
§ 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).