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

QLAB version 3.0 adds a Cardiac 3DQ Plug-in (3D viewer with 3D measurements), G1 3D viewer Plug-in and an MVI Plug-in to the cleared QLAB version 2.0.

The Cardiac 3DQ plug-in provides a means of opening. displaying, manipulating and measuring 3D inage files from currently cleared Plilips Ultrasound systems The 3DQ plug-in also allows distance, area, volume and mass measurements from MultiPlanar Reconstruction (MPR) images derived the 3D data sets. The software also provides a means of exporting the data generated by the plug in module in a form accessible to the end user.

Gl (General Imaging) ND Viewer Plug-in reads DICOM compliant liles generated by currently cleared Philips Ultrasound systems. It contains tools for changing 3D volume rendering parameters. The volume rendering is done using the rendering engine shipping with the Boris Platform and Philips HDI 5000. Therefore the main volume rendering controls are the same as on the imaging system.

MVI (Microvascular Imaging) Plug-in reads DICOM compliant files generated by the Philips Boris Platform and the Philips HDI 5000 Platforms. It performs a Maximum Intensity Projection convolution of the cine' information and allows viewing of the processed information. It provides tools for export of the resulting information in a standard AVI tile formal for use in presentations. The processing is accomplished exactly as in the Predicate device (HDI 5000) with the exception that there are no user selectable processing changes possible.

AI/ML Overview

The provided text is a 510(k) Summary for the QLAB Quantification software, which focuses on device description, predicate devices, and general safety and effectiveness concerns. It explicitly states that "No performance standards for PACS systems or components have been issued under the authority of Section 14" and that the software "has been designed to comply with the following voluntary standards: MSDN Microsoft Developer's Network October 2001 and ISO Joint Photographic Experts Group (JPEG) Image Compression Standard."

Crucially, the document does not contain information about specific performance acceptance criteria or a study proving that the device meets such criteria. It mentions "software design, verification and validation testing" and a "risk assessment" but provides no details on the methodologies, results, or ground truth used for these internal processes.

Therefore, I cannot fully answer your request based on the provided text.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not specify any quantitative acceptance criteria (e.g., accuracy, sensitivity, specificity, measurement tolerances) or reported device performance metrics against such criteria. It only references compliance with general software development and image compression standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document does not mention the sample size of any test set used, nor does it specify the provenance, type (retrospective/prospective), or origin of any data used for testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. The document does not refer to the use of experts for establishing ground truth, nor does it describe their number or qualifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. There is no mention of an adjudication method as no test set details are provided.

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

Cannot be provided. The document does not mention any MRMC comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. This device is described as a quantification and viewing software, not specifically an AI-assisted diagnostic tool in the sense of predictive or interpretive algorithms.

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

Cannot be determined from the text. While the device performs "quantification" and "volume rendering," which are algorithmic tasks, the document does not distinguish between testing done in a standalone manner versus with a human in the loop. The device is fundamentally a workstation for human interaction.

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

Cannot be provided. The document does not specify the type of ground truth used for any testing.

8. The sample size for the training set

Cannot be provided. The document does not mention a training set or its sample size.

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

Cannot be provided. As no training set is mentioned, information on how its ground truth was established is absent.

Summary

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FEB 1 7 2004

K040227
page 1 of 2

510(k) Summary of Safety and Effectiveness

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

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

Steve Singlar Regulatory Submissions Manager Philips Ultrasound 3000 Minuteman Koad Andover, MA 01810-1099 Telephone: (978) 659-1201 Facsimile: (978) 975 7324 E-mail: Steve Singlar(@Philips.com

Date prepared: 15 January 2004

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:	QLAB Quantification
Classification Name:	Picture Archiving and Communications System, Class II

3) Device Description

QLAB version 3.0 adds a Cardiac 3DQ Plug-in (3D viewer with 3D measurements), G1 3D viewer Plug-in and an MVI Plug-in to the cleared QLAB version 2.0.

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K040227
Page 2 of 2

4) Performance Standards

No performance standards for PACS systems or components have been issued under the authority of Section 14. The QLAB software has been designed to comply with the following voluntary standards:

MSDN Microsoft Developer's Network October 2001 .
ISC) Joint Photographic Experts Group (JPEG) Image Compression Standard .

5) General Safety and Effectiveness Concerns

The device labeling contains operating instructions for the safe and effective use of the QLAB software.

6) Substantially Eguivalent Devices

Philips Ultrasound believes that the QLAB software is substantially equivalent to other commercially available products, specifically Philips M2424 Diaguostic Ultrasound System and the TomTec Cardio-View.

7) Software

Software development for the QLAB software follows documented processes for software design, verification and validation testing. A risk assessment has been completed to identify potential design hazards that could cause an error or injury based on the use of the quantification results. Appropriate steps have been taken to control all identified risks for this type of image display and quantification product.

8) Conclusions

The QLAB software is designed and manufactured to meet United States and international standards for the display and quantification of invages acquired on Phillips Ultrasound devices. The system is designed to incorporate components common to all image viewing systems for the display, manipulation and quantification tasks within a clinical setting. The QLAB software incorporates features of predicate devices cleared through premarket notification and no new issues of safety or effectiveness are raised.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Ultrasound, Inc. % Ms. Laura Danielson Responsible Third Party Official TÜV Product Service 1775 Old Highway 8

NEW BRIGHTON MN 55112-1891

Re: K040227

Trade/Device Name: OLAB Quantification Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II

Product Code: 90 LLZ Dated: January 30, 2004 Received: February 2, 2004

Dear Ms. Danielson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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,

FEB 17 2004

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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Bugden

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2 FDA Indication for Use Form

510(k) Number: Unknown YO40227

Device Name: QLAB Quantification Software with Cardiac 3DQ Plug-in, 3D General Imaging Viewer Plug-in and a Microvascular Imaging Plug-in.

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 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David L. Heymann

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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).