(32 days)
The Q LAB Quantification software is a Windows 2000/Windows XP software application package. It is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
The Q LAB software provides a means of opening and displaying image files, creating AVI and BMP files from the image data displayed by the software. The Strain Rate quantification plug-in module is designed to operate within the QLAB software by creating a "line of interest" (called "M-Line") that is overlaid on the image data displayed by the software. The plug-in analyzes the content of the image data contained within the M-Line figure, presenting the velocity, strain-rate and strain data in XY graphic and virtual M-Mode format. The software provides a means of exporting the data generated by the plugin module in a form accessible to the end user.
The provided 510(k) summary for K023877, "Q LAB Quantification Software with Strain Rate Quantification Plug-in," describes a Picture Archiving and Communications Systems (PACS) workstation software that includes a plug-in for strain rate quantification from ultrasound image data. However, the document does not contain specific acceptance criteria, comprehensive performance studies with detailed results, or the other requested information for a device that relies on clinical performance metrics.
The document mainly focuses on:
- Device Description: How the software functions – displaying images, creating AVI/BMP files, and the strain rate plug-in creating an "M-Line" to analyze image data for velocity, strain-rate, and strain, then presenting this data graphically and in virtual M-Mode.
- Safety and Effectiveness: Stating that the software follows documented processes for design, verification, and validation, and that a risk assessment was completed.
- Substantial Equivalence: Claiming substantial equivalence to GE's Strain-Rate software.
- Regulatory Compliance: Citing compliance with voluntary standards (MSDN, JPEG) and United States and international standards for image display and quantification.
Therefore, based solely on the provided text, I cannot complete a table of acceptance criteria and reported device performance, nor can I provide information regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies because this information is not present in the given document.
This device appears to be cleared based on its equivalence to existing PACS systems and similar quantification software, focusing on its technical function as a display and quantification tool rather than a diagnostic aid with specific clinical performance targets (like sensitivity/specificity for disease detection). The FDA clearance letter also confirms that it was reviewed for substantial equivalence to legally marketed predicate devices, not requiring rigorous clinical performance claims or studies as would be typical for a device making diagnostic claims.
Summary of what can be extracted from the document related to performance and validation (though it doesn't meet all your requested criteria):
- No specific acceptance criteria or quantitative performance results are provided in the document.
- No detailed study results or data are presented to "prove" the device meets acceptance criteria. The document states "Software development for the Q LAB software follows documented processes for software design, verification and validation testing," indicating internal testing, but no public-facing details of these tests are provided.
Here’s a table reflecting the available (or explicitly missing) information:
| Information Category | Details from Document (K023877) |
|---|---|
| 1. Acceptance Criteria & Reported Device Performance | Acceptance Criteria: Not explicitly stated in the document. The document mentions compliance with "voluntary standards" (MSDN, JPEG) and "United States and international standards for the display and quantification of images." It also states the software "is designed and manufactured to meet United States and international standards for the display and quantification of images acquired on Phillips Ultrasound devices." Reported Device Performance: No quantitative performance metrics (e.g., accuracy, precision, sensitivity, specificity for quantification results) are reported in the summary. The device's function is described: creating a "line of interest" (M-Line) on image data, analyzing content within the M-Line, and presenting velocity, strain-rate, and strain data in XY graphic and virtual M-Mode format. |
| 2. Sample Size & Data Provenance (Test Set) | Not provided. The document implies internal "verification and validation testing" but does not detail any specific test sets, their sizes, or data provenance. |
| 3. Number & Qualifications of Experts (Ground Truth) | Not applicable/Not provided. Clinical performance for a diagnostic claim is not made. Ground truth establishment by experts for a test set is not described. |
| 4. Adjudication Method (Test Set) | Not applicable/Not provided. |
| 5. MRMC Comparative Effectiveness Study | No MRMC study is mentioned. The device is a quantification tool, not a diagnostic aid where human reader improvement with AI assistance would typically be measured. The substantial equivalence claim is made against GE's Strain-Rate software, implying functional equivalence rather than enhanced human performance. |
| 6. Standalone Performance Study | No standalone (algorithm-only) performance study results are provided in this summary. The device is software designed to operate within a PACS workstation for image display and quantification. Its performance would ideally be measured by the accuracy of its quantification against a reference, but these details are not supplied. |
| 7. Type of Ground Truth Used | Not applicable/Not provided within the scope of this summary. For quantification software, ground truth for performance assessment would typically involve comparing the software's measurements (velocity, strain-rate, strain) to a gold standard obtained through alternative, highly accurate methods or expert manual measurements on validated datasets. Such details are absent. |
| 8. Sample Size for Training Set | Not provided. As this is an older submission (2002) and likely a rule-based or conventional image processing algorithm rather than a deep learning AI, the concept of a "training set" in the modern AI sense might not be directly applicable, or its size not typically disclosed for such devices at the time. |
| 9. How Ground Truth for Training Set was Established | Not applicable/Not provided. If internal validation involved comparing algorithm outputs to known values (e.g., from meticulously annotated images or physical phantoms), that methodology is not described here. |
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510(k) Summary of Safety and Effectiv
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
Lynn Harmer, Manager, Regulatory Submissions Philips Ultrasound, a Philips Medical System Company 22100 Bothell Everett Highway Bothell, WA 98021-8431 Telephone: (425) 487-7312 Facsimile: (425) 487-8666 E-mail: Lynn.Harmer@Philips.com
Date prepared: 19 November 2002
- 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: | Q LAB Quantification Software with Strain Rate Quantification Plug-in |
| Classification Name: | Picture Archiving and Communications System, Class II |
3) Device Description
The Q LAB software provides a means of opening and displaying image files, creating AVI and BMP files from the image data displayed by the software. The Strain Rate quantification plug-in module is designed to operate within the QLAB software by creating a "line of interest" (called "M-Line") that is overlaid on the image data displayed by the software. The plug-in analyzes the content of the image data contained within the M-Line figure, presenting the velocity, strain-rate and strain data in XY graphic and virtual M-Mode format. The software provides a means of exporting the data generated by the plugin module in a form accessible to the end user.
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- Performance Standards
No performance standards for PACS systems or components have been issued under the authority of Section 514. The Q LAB software has been designed to comply with the following voluntary standards:
- Performance Standards
MSDN - Microsoft Developer's Network October 2001 ISO Joint Photographic Experts Group (JPEG) Image Compression Standard
- General Safety and Effectiveness Concerns The device labeling contains operating instructions for the safe and effective use of the Q LAB software.
6) Substantially Equivalent Devices
Philips Ultrasound believes that the Strain-Rate Imaging quantification capabilities of the Q LAB software make it substantially equivalent to other commercially available products, specifically GE's Strain-Rate software.
7) Software
Software development for the Q LAB 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.
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8) Conclusions
The Q LAB software is designed and manufactured to meet United States and international standards for the display and quantification of images 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 Q LAB software incorporates features of predicate devices cleared through premarket notification and no new issues of safety or effectiveness are raised.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lynn Harmer Manager, Regulatory Submissions Philins Medical Systems 22100 Bothell Everett Highway BOTHELL WA 98021-8431
Re: K023877
Trade/Device Name: O LAB Quantification Software with Strain Rate Ouantification Plug-in Regulation Number: 21 CFR 892.2050 · Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: November 19, 2002
Received: November 21, 2002
Dear Ms. Harmer:
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 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.
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This letter will allow you to begin marketing your device as described in your 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 this 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" (21 CFR Part 807.97). Other general information on vour 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. Snogdin
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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Q LAB Strain Rate Quantification Software
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Appendix A - Indications for Use
Device Name: Q LAB Quantification Software with Strain Rate Quantification Plug-in
Indications for Use:
The Q LAB Quantification software is a Windows 2000/Windows XP software application package. It is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
877
Prescription Use
David A. Peterson
(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number _
§ 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).