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

Device Description

OLAB Quantification software is available either as a stand-alone product that can function on a standard.PC, on board a dedicated workstation, or on-board Philips' ultrasound systems. It can be used by trained healthcare professionals for the on-line and off-line review and quantification of ultrasound studies in healthcare facilities/hospitals.

The QLAB Quantification software application package is designed to view and quantify image data acquired on Philips ultrasound products. Cardiac Motion Quantification (CMQ) is a plug-in included in Philips QLAB Quantification software.

The CMO plug-in is an application within OLAB intended to provide cardiac motion quantification. OLAB Quantification software is intended for use in healthcare facilities/hospitals by trained healthcare professionals.

OLAB CMO modifications were implemented to provide clients with improved reproducibility and consistency between users, as well as to provide users with a reduction of workflow steps. The modifications described in this Special 510(k) submission do not alter the intended use of the OLAB Quantification software with the CMO plug-in.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the QLAB CMQ Plug-in Modifications, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Modified CMQ vs. Unmodified CMQ)	Reported Device Performance
Improved workflow: fewer mouse clicks for typical assessment	Verification and validation testing concluded the modification achieved this.
Improved workflow: decreased average time for typical assessment	Verification and validation testing concluded the modification achieved this.
Decreased intra-observer variability of assessments	Verification and validation testing concluded the modification achieved this.
Decreased inter-observer variability of assessments	Verification and validation testing concluded the modification achieved this.
Safe and effective release, no new risks introduced	Verification and validation testing concluded the modification achieved this.
Meets all defined reliability requirements and performance claims	Testing demonstrated this.

2. Sample Size and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective). It mentions "Philips verification and validation processes" and "system level tests, performance tests, and safety testing from hazard analysis," but lacks specific details on the datasets used in these tests.

3. Number of Experts and Qualifications

The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications. It states that the device "can be used by trained healthcare professionals," implying expert users, but doesn't detail their involvement in the testing.

4. Adjudication Method

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth or evaluating the test set.

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

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on the improvements of the modified CMQ plugin over the unmodified CMQ plugin in terms of workflow and variability, rather than comparing it to human-only performance or quantifying an effect size of human improvement with AI assistance.

6. Standalone (Algorithm Only) Performance

The device itself is a "plug-in" within a larger software suite (QLAB). While it's a "quantification software" that can function "either as a stand-alone product that can function on a standard PC, on board a dedicated workstation, or on-board Philips' ultrasound systems," the performance claims are related to its function within the QLAB environment, and specifically the modifications made to the CMQ plug-in. The provided text doesn't explicitly detail a standalone algorithm-only performance study contrasting its output against a ground truth without human interaction beyond the general claims of decreased intra-observer and inter-observer variability. The "modifications ... were implemented to provide clients with improved reproducibility and consistency between users," which implies human interpretation is still integral, but the device assists this process.

7. Type of Ground Truth

The document explicitly states the intent to "provide clients with improved reproducibility and consistency between users, as well as to provide users with a reduction of workflow steps" and to achieve "Decreased intra-observer variability of assessments; and Decreased inter-observer variability of assessments." This strongly suggests that the ground truth for evaluating these improvements was based on expert consensus or comparative measurements performed by experts, where the goal was to minimize the deviation of measurements between and within experts, facilitated by the software. It does not mention pathology or outcomes data as the primary ground truth for the specific performance claims of this modification.

8. Sample Size for the Training Set

The document does not include any information about the sample size used for a training set. As this is a "Special 510(k) Premarket Notification" for modifications to an already cleared device, it's possible that the core algorithm was trained previously, and this submission focuses on validation of the changes.

9. How Ground Truth for Training Set was Established

Since no training set information is provided, there is no description of how ground truth for a training set was established.

Summary

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2120525 el of 2

MAR - 9 2012

Special 510(k) Premarket Notification

QLAB CMQ Plug-in Modifications

510(k) Summary

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

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

Philips Ultrasound, Inc. 3000 Minuteman Road Andover, MA 01810-6302 Penny Greco, Regulatory Affairs Specialist Tel: (978) 659-4615 Fax (978) 975-7324 E-mail: penny.greco@philips.com

Date prepared: February 15, 2012

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 Systems Workstation

Proprietary Name: Classification Name: QLAB CMQ Plug-in CFR 892.2050, system, image processing, radiological, 90 LLZ, Class II

3) Substantially Equivalent Devices

Philips Ultrasound believes that the modified QLAB CMQ Plug-in is substantially equivalent to the previously cleared OLAB TMQ Plug-in marketed pursuant to K070792, and K042540. Originally marketed as TMQ, the QLAB CMQ Plug-in was documented in a letter to file as described in QLAB 510(k) K110414.

Device Description

Page 1 of 2

Philips Ultrasound

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K120525
Page 2 of 2

Special 510(k) Premarket Notification

QLAB CMO Plug-in Modifications

5) Indications for Use

OLAB Ouantification software is a software application package. It is designed to view and quantify image data acquired on Philips Healthcare ultrasound products.

6) Technological characteristics

The OLAB Quantification software with the modified CMQ plug-in has the same technological characteristics as the legally marketed device.

7) Non-clinical performance data

No performance standards for PACS systems or components have been issued under the authority of Section 514. The CMQ modifications were tested in accordance with Philips verification and validation processes. Verification and validation data support the following nonclinical claims for the modified CMQ software relative to the unmodified CMQ software:

Improved workflow fewer mouse clicks for typical assessment; 1.
Improved workflow decreased average time for typical assessment; 2.
1. Decreased intra-observer variability of assessments; and
Decreased inter-observer variability of assessments. 4.

Verification and validation testing concluded that the modified CMQ is safe and effective and introduced no new risks.

8) General Safety and Effectiveness Concerns

The device labeling contains operating instructions for the safe and effective use of the QLAB Quantification software with the modified CMQ plug-in.

9) Conclusions

Verification, validation, and testing activities, where required to establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate were performed. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Testing performed demonstrates that the QLAB Quantification software with modified CMQ plug-in meets all defined reliability requirements and performance claims.

Page 2 of 2

Philips Ultrasound

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

MAR - 9 2012

Philips Ultrasound, Inc. % Mr. Mark Job Responsible Third Party Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K120525

Trade/Device Name: Philips OLAB Quantification Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 21, 2012 Received: February 22, 2012

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 187 as career in 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 11 your de ree to traces in the regulations affecting your device can be found in Title 21, additional controller Elizang (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 I lease be determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I outer station of 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/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 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,

Janine M. Morris

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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K120525 510(k) Number (if known):

Device Name: Philips QLAB Quantification Software

Indications for Use:

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

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-counter Use (21 CFR 801 Subpart C)

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

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

Mary S. Postel

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

K120525

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).