(152 days)
The IQQA-Liver is a PC-based, self-contained, non-invasive image analysis software application for reviewing serial multi-phase CT acquisitions of the liver. Combining image viewing, processing and reporting tools, the software is designed to support physicians in the visualization, evaluation and reporting of liver and physician-identified liver lesions.
The software supports a workflow based on automated image registration for viewing and analyzing multi-phase volume datasets. It also includes tools for interactive segmentation and labeling of liver segments and vascular structures. The software provides functionalities for manual or interactive segmentation of physician-identified lesions, and allows for regional volumetric analysis of such lesions in terms of size, shape, position and enhancement pattern, providing information for physician's assessment of lesion characterization.
The software is designed for use by trained physicians. Image source: DICOM.
The IQQA-Liver Software is a self-contained, non-invasive radiographic image analysis application that is designed to run on standard PC hardware. The image input is DICOM. Combining image processing, viewing and reporting tools, the software supports physicians in the visualization, evaluation and reporting of liver and physician identified liver lesions. Viewing tools include 2D axial image viewing, window level adjustment, a pre-defined optimized liver window level setting, synchronized viewing of multi-phase datascts, MPR and MIP. Analysis and evaluation tools include segmentation of structures utilizing user input of seeding points, interactive labeling of segmented areas, quantitative measurement derived from segmentation and labeling results, and the measurement of distance between physician specified structures to landmarks. Reporting tools in the software automatically assemble information (including physician identified lesion locations, measurement information, physician-input lesion characterization, lesion ROl images across multi-phases, and illustrative snapshots of the GUI taken by physicians) for physician's confirmation and for further diagnosis note input. The IQQA-Liver software supports a workflow based on automated registration for viewing and analyzing multi-phase volume datasets. The software automatically matches the spatial location of axial images across multi-phases, and provides synchronized viewing of multi-phase dataset to aid visualization. The software further includes tools for interactive segmentation and interactive labeling of liver segments and vascular structures (such as liver lobes, vessels and major branches), thus facilitating the visualization of spatial relationship between suspicious liver lesions and specified anatomical structures/landmarks. The tools also allow for interactive segmentation of physician-identified lesions using user input of seed points, and regional analysis of such lesions with respect to size, shape, position and enhancement pattern, thus providing information to help physician's assessment of lesion characterization. The software is designed for use by trained physicians only. Physicians make all final patient management decisions.
The provided text is a 510(k) summary for the EDDA Technology IQQA-Liver Software. While it describes the device's intended use, comparison to predicate devices, and general statements about testing, it does not contain detailed information about specific acceptance criteria and a study proving those criteria are met.
The document states:
- "Testing was performed according to internal company procedures. Software testing and validation were done according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent."
This is a general statement of compliance, but it does not provide the quantitative acceptance criteria, the details of a study, or the specific performance metrics.
Therefore, I cannot populate the table or answer most of your detailed questions based on the provided text.
Here's what can be inferred or explicitly stated from the document, though it falls short of your request for specific acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not list specific, quantifiable acceptance criteria or reported performance results (e.g., accuracy, precision, sensitivity, specificity, or error rates for segmentation, volume analysis, etc.). It only broadly claims that "actual device performance satisfies the design intent."
2. Sample size used for the test set and the data provenance
- Cannot be determined. The document does not specify the sample size of the test set or the origin (country, retrospective/prospective) of the data used for testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Cannot be determined. The document does not mention the use of experts for establishing ground truth or their qualifications. Given the device's function involves physician-identified lesions and analysis tools, it's implied that physician input is central, but no formal ground truth establishment process is described for testing.
4. Adjudication method for the test set
- Cannot be determined. The document does not describe any adjudication methods.
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 determined. The document does not mention a multi-reader, multi-case (MRMC) study or any comparative effectiveness study measuring human reader improvement with or without AI assistance. The device is described as "supporting physicians" but not necessarily replacing or directly augmenting their diagnostic accuracy in a quantifiable comparison presented here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be determined. The document explicitly states the device is "designed for use by trained physicians" and that "Physicians make all final patient management decisions." This framework suggests a human-in-the-loop design, but it doesn't preclude standalone testing of individual algorithms within the software, though such testing is not detailed.
7. The type of ground truth used
- Cannot be determined with certainty. The software relies on "physician-identified liver lesions" and "interactive segmentation of physician-identified lesions using user input of seed points." This suggests that "expert consensus" or "physician input" forms the basis of the data the software processes, but it does not describe how a ground truth was established for testing or validation purposes. It's likely that a clinical reference (e.g., pathology, clinical follow-up) would have been used for any robust validation, but this is not stated.
8. The sample size for the training set
- Cannot be determined. The document focuses on the device's intended use and comparison to predicates, not on its development or training process.
9. How the ground truth for the training set was established
- Cannot be determined. Similar to point 8, this information is not present in the provided 510(k) summary.
In summary, the provided 510(k) document is a regulatory summary focused on substantial equivalence to predicate devices and does not detail the technical performance studies and acceptance criteria typically found in clinical trial reports or more comprehensive technical files.
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EXHIBIT 2
EDDA Technology 510(k) Summary
NOV 1 3 2006
14 Washington Road, Building 2 Princeton Junction, NJ 08550 Tel: 609-936-8282 Fax: 609-799-1545 Contact: Xiaolan Zeng, Vice President Date prepared: May 25, 2006
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- Identification of the Device: Proprietary - Trade Name: IQQA-Liver Software Classification Name: System, Image Processing, Radiological, Product Code LLZ Common/Usual Name: Radiological Image Processing System
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- Equivalent legally marketed devices:
| Manufacturer | Name of the PredicateDevice | FDA 510(k)Number | FDA ClearanceDate |
|---|---|---|---|
| Mevis TechnologyGMBH & CO.KG | Mevis LiverAnalyser /LiverViewer Software | K051528 | 07/20/2005 |
| GE MedicalSystems | Volume Viewer Plus | K041521 | 06/22/2004 |
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- Indications for Use (intended use): The IQQA-Liver is a PC-based, self-contained, noninvasive image analysis software application for reviewing serial multi-phase CT acquisitions of the liver. Combining image viewing, processing and reporting tools, the software is designed to support physicians in the visualization, evaluation and reporting of liver and physician-identified liver lesions. The software supports a workflow based on automated image registration for viewing and analyzing multi-phase volume datasets. It also includes tools for interactive segmentation and labeling of liver segments and vascular structures. The software provides functionalities for manual or interactive segmentation of physician-identified lesions, and allows for regional volumetric analysis of such lesions in terms of size, shape, position and enhancement pattern, providing information for physician's assessment of lesion characterization. The software is designed for use by trained physicians. Image source: DICOM.
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- Description of the device: The IQQA-Liver Software is a self-contained, non-invasive radiographic image analysis application that is designed to run on standard PC hardware. The image input is DICOM. Combining image processing, viewing and reporting tools, the software supports physicians in the visualization, evaluation and reporting of liver and physician identified liver lesions. Viewing tools include 2D axial image viewing, window level adjustment, a pre-defined optimized liver window level setting, synchronized viewing of multi-phase datascts, MPR and MIP. Analysis and evaluation tools include segmentation of structures utilizing user input of seeding points, interactive labeling of segmented areas, quantitative measurement derived from segmentation and labeling results, and the measurement of distance between physician specified structures to landmarks. Reporting
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tools in the software automatically assemble information (including physician identified lesion locations, measurement information, physician-input lesion characterization, lesion ROl images across multi-phases, and illustrative snapshots of the GUI taken by physicians) for physician's confirmation and for further diagnosis note input. The IQQA-Liver software supports a workflow based on automated registration for viewing and analyzing multi-phase volume datasets. The software automatically matches the spatial location of axial images across multi-phases, and provides synchronized viewing of multi-phase dataset to aid visualization. The software further includes tools for interactive segmentation and interactive labeling of liver segments and vascular structures (such as liver lobes, vessels and major branches), thus facilitating the visualization of spatial relationship between suspicious liver lesions and specified anatomical structures/landmarks. The tools also allow for interactive segmentation of physician-identified lesions using user input of seed points, and regional analysis of such lesions with respect to size, shape, position and enhancement pattern, thus providing information to help physician's assessment of lesion characterization. The software is designed for use by trained physicians only. Physicians make all final patient management decisions.
| Device of 510(k)submission: | Predicate Device: | Predicate Device: | |
|---|---|---|---|
| IQQA-Liver Software | Mevis LiverAnalyser/LiverViewer software | Volume Viewer Plus | |
| K051528 | K041521 | ||
| Manufacturer | EDDA Technology, Inc. | Mevis TechnologyGMBH & CO.KG | GE Medical Systems |
| Indicationsfor Use | The IQQA-Liver is a PC-based, self-contained,non-invasive imageanalysis softwareapplication for reviewingserial multi-phase CTacquisitions of the liver.Combining imageviewing, processing andreporting tools, thesoftware is designed tosupport physicians in thevisualization, evaluationand reporting of liver andphysician-identified liverlesions.The software supports aworkflow based onautomated imageregistration for viewingand analyzing multi-phase volume datasets. It | The Mevis LiverAnalyzer/ LiverViewerSoftwareTM device isintended for preoperativeplanning in liver surgery.The device is used toanalyze data and todisplay image analysisand risk analysis resultsfor the preoperativeplanning in liver surgery,e.g. organ segmentation,tumor segmentation,segmentation ofintrahepatic vessels aswell as the approximationof vascular territories.Preoperative evaluationof specific surgerystrategies is supported bythe feature tointeractively definevirtual resections splitting | Volume Viewer Plus ismedical diagnostic softwarethat allows the processing,review, analysis andcommunication of 3Dreconstructed images andtheir relationship to originallyacquired images from CT,MR, X-Ray Angio and PETscanning devices. Thecombination of acquiredimages, reconstructed images,annotations andmeasurements performed bythe clinician are intended toprovide to the referringphysician clinically relevantinformation for diagnosis,surgery and treatmentplanning. |
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- Safety and Effectivencss, comparison to predicate devices:
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| also includes tools forinteractive segmentationand labeling of liversegments and vascularstructures. The softwareprovides functionalitiesfor manual or automatedsegmentation ofphysician-identifiedlesions, and allows forregional volumetricanalysis of lesions interms of size, shape,position andenhancement pattern,providing information forphysician's assessment oflesion characterization.The software is designedfor use by trainedphysicians. Image source:DICOM. | the liver or to calculatesafety marginsaround lesions identifyingaffected vascularbranches and vascularterritories supplied ordrained by thesebranches. Medical imagedata is derived fromvarious sources (i.e. CTscanners, MRI scanners).Typical users of thissystem are trainedprofessionals, includingphysicians, nurses, andtechnicians. | ||
|---|---|---|---|
| HardwareConfiguration | standard PC hardware | standard PC hardware | standard PC hardware |
| UserInterface | A graphical user interfacefor users to interact withthe software, select toolsand drive workflow | A graphical user interfacefor users to interact withthe software, select toolsand drive workflow | A graphical user interface forusers to interact with thesoftware, select tools anddrive workflow |
6. Testing Information and Conclusion
In all material respects, the IQQA-Liver Software is substantially equivalent to the predicate systems. Testing was performed according to internal company procedures. Software testing and validation were done according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal features an eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
EDDA Technology, Inc. % Mr. Casey Conry Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Road MELVILLE NY 11747
NOV 13 2016
Re: K061696
Trade/Device Name: IQQA-Liver Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 23, 2006 Received: October 30, 2006
Dear Mr. Conry:
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 (Premarket Approval), 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.
Image /page/3/Picture/10 description: The image is a circular logo or emblem. The text "1906 - 2006" is at the top of the circle. The letters "FDA" are in the center of the circle, and the word "Centennial" is below the letters. There are four stars at the bottom of the circle.
Protecting and Promoting Public Health
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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 Orth 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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
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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Indications for Use
510(k) Number (if known): __ Ko61696__________________________________________________________________________________________________________________________________________
Device Name: IQQA-Liver Software
The IQQA-Liver is a PC-based, sclf-contained, non-invasive image analysis software application for reviewing serial multi-phase CT acquisitions of the liver. Combining image viewing, processing and reporting tools, the software is designed to support physicians in the visualization, evaluation and reporting of liver and physician-identified liver lesions.
The software supports a workflow based on automated image registration for viewing and analyzing multi-phase volume datasets. It also includes tools for interactive segmentation and labeling of liver segments and vascular structures. The software provides functionalities for manual or interactive segmentation of physician-identified lesions, and allows for regional volumetric analysis of such lesions in terms of size, shape, position and enhancement pattern, providing information for physician's assessment of lesion characterization.
The software is designed for use by trained physicians. Image source: DICOM.
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)
Nancy L. Broadon
(Division Sign-Off)
Division of Reproductive, A and Radiological Devices 510(k) Number
Page 1 of 1
§ 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).