(123 days)
Not Found
No
The description focuses on automated image processing, registration, and segmentation tools, but does not explicitly mention or imply the use of AI or ML algorithms. The "automated" features described appear to be based on traditional image processing techniques rather than learned models.
No
The device is an image analysis software that provides tools for visualization, evaluation, and reporting of body imaging studies, which is for diagnostic and planning purposes, not for direct therapeutic intervention.
Yes
The device aids in the visualization, evaluation, and reporting of body imaging studies, helping physicians to evaluate physician-identified lesions, and support treatment planning, monitoring, and follow-up. This is consistent with the definition of a diagnostic device.
Yes
The device is described as a "PC-based, self-contained, non-invasive image analysis software application" and "designed to run on standard PC hardware." It processes DICOM images from existing CT and MR scanners and provides analysis and reporting tools. There is no mention of proprietary hardware included with the device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description clearly states that IQQA-BodyImaging is a software application for reviewing body imaging studies derived from CT and MR scanners. These are images of the body itself, not specimens taken from the body (like blood, urine, tissue biopsies, etc.).
- The intended use is for image analysis and visualization. The software helps physicians review, process, and report on medical images. While this information is used to support diagnosis and treatment planning, the software itself is not performing a test on a biological sample to determine a medical condition.
The device falls under the category of medical image analysis software, which is a type of medical device but not an IVD.
N/A
Intended Use / Indications for Use
IQQA-BodyImaging is a PC-based, self-contained, non-invasive image analysis software application for reviewing body imaging studies (including thoracic, abdominal and pelvic) derived from CT and MR scanners. Combining image viewing, processing and reporting tools, the software is designed to support the visualization, evaluation, and reporting of body imaging studies and physician-identified lesions.
The software supports a workflow based on automated image registration for viewing and analyzing multiphase and multiple time-point volume datasets. It includes tools for interactive segmentation and labeling of organ segments and vascular/ductal/airway structures. The software provides functionalities for manual or interactive segmentation of physician-identified lesions, interactive definition of virtual resection plane and virtual needle path, and allows for regional volumetric analysis of such lesions in terms of size, position, margin, and enhancement pattern, providing information for physician's evaluation and treatment planning, monitoring, and follow-up.
The software is designed for use by trained professionals, including physicians and technicians. Image source: DICOM.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The IQQA-BodyImaging 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. The data utilized is derived from CT and MR scanners, and includes thoracic/abdominal/pelvic images.
Combining image processing, viewing and reporting tools, the software supports the visualization, evaluation and reporting of body imaging scans and physician identified lesions. Viewing tools include 2D original DICOM image viewing, window level adjustment, predefined optimized window level setting, synchronized viewing of multi-phase datasets or volumes from multiple time-points, MPR (orthogonal, oblique and curved), MIP and MinIP, volume rendering. Analysis and evaluation tools include automatic/interactive segmentation of structures utilizing user input of seeding points and bounded boxes, interactive labeling of segmented areas, user tracing and interactive editing, quantitative measurement derived from segmentation and labeling results, and the measurement of distance between physician specified structures and landmarks. Reporting tools in the software automatically assemble information including physician identified lesion locations, measurement information, physician-input lesion characterization, lesion snapshot images across multi-phases or multiple time-points, information of organ segments and vessels/ducts/airways, and illustrative snapshots of the GUI taken by physicians, for physician's confirmation and further diagnosis and patient management note input.
The IQQA-BodyImaging software supports a workflow based on automated registration for viewing and analyzing multiphase or multiple time-point volume datasets. The software automatically matches the spatial location of original DICOM images across contrasted multiphases or multiple time-points, and with physicians' interactive adjustment, to enable synchronized viewing of datasets simultaneously. Physician may also activate the temporal movie display of selected slice locations across multi-phases to aid visualization and evaluation.
After identifying and marking lesions on 2D image display, physicians can either manually trace lesion boundary or activate automated tools to segment lesion. The software further includes tools for interactive segmentation and interactive labeling of organ segments and vascular/ductal/airway structures (such as liver lobes, major branches of vessels/ducts/airways), thus facilitating the visualization of spatial relationship between suspicious lesions and specified anatomical structures/landmarks.
The software provides functionalities for interactive adjustment of user-defined margin size around the lesion, interactive definition of virtual resection plane, interactive definition of virtual needle path to lesion and local zone, regional analysis of lesions with respect to suze, shape, position, margin, and enhancement pattern etc, synchronized view of lesion and information between planning/baseline study and monitoring/follow-up studies, thus providing information to support physician's to evaluation of physician-identified lesions as well as treatment planning, monitoring and follow-up assessment.
The software is designed for use by trained professionals only (physicians, radiologists, surgeons, hospital technicians etc). Physicians make all final diagnosis and patient management decisions.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR
Anatomical Site
thoracic, abdominal and pelvic OR Thoracic, Abdominal, Pelvic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, including physicians and technicians. OR physicians, radiologists, surgeons, hospital technicians etc
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Retrospective clinical patient studies of CT and MR modalities for the thoracic, abdominal and pelvic body parts were used.
Experiments involving phantom image pairs scanned at different times with different positioning and orientations, and retrospectively collected patient studies scanned at different times during clinical practice were conducted.
Software testing at two clinical sites.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Experimental results on simulated images to study measurement accuracy of segmentation and measurement tools.
Sample Size: Not specified.
Key Results: Showed less than 1.5% in volume measurement difference as compared with the ground truth.
Study Type: Intra-observer consistency study using IQOA-BodyImaging interactive segmentation and measurement tools.
Sample Size: Not specified, but involved "retrospective clinical patient studies of CT and MR modalities for the thoracic, abdominal and pelvic body parts".
Key Results: The mean volume measurement differences by two physicians were 0.4%, 1.5% and 2.5%, respectively.
Study Type: Registration tool experiments.
Sample Size: Not specified, but involved "phantom image pairs scanned at different times with different positioning and orientations, and retrospectively collected patient studies scanned at different times during clinical practice".
Key Results: Mean interactive registration error of 0.2394mm with a standard deviation of 0.2261mm on phantom studies. Mean initial automated registration error of 0.5594mm with a standard deviation of 0.5448mm on patient studies with synthetic deformations. Mean interactive registration error of 0.5388mm with a standard deviation of 0.7150mm on retrospective patient studies that are scanned at different times during clinical practice.
Study Type: Software validation at clinical sites.
Sample Size: Two clinical sites.
Key Results: Physicians used the software to review CT and MR body imaging scans, validate major functionalities, and provide feedback.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Volume measurement difference:
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is rendered in black, and the text is also in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 31, 2014
EDDA Technology % Mr. Daniel Kamm Regulatory Engineer 5 Independence Way PRINCETON NJ 08540
Re: K141745
Trade/Device Name: IOOA-BodyImaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 22, 2014 Received: September 29, 2014
Dear Mr. Kamm:
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.
Sm. 7
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K141745
Device Name IQQA-BodyImaging Software
Indications for Use (Describe)
IQQA-BodyImaging is a PC-based, self-contained, non-invasive image analysis software application for reviewing body imaging studies (including thoracic, abdominal and pelvic) derived from CT and MR scanners. Combining image viewing, processing and reporting tools, the software is designed to support the visuation, and reporting of body imaging studies and physicianidentified lesions.
The software supports a workflow based on automated image registration for viewing and multiphase and multiple timepoint volume datasets. It includes tools for interactive segments and vascular/ductal/artual structures. The software provides for manual or interactive segmentation of physician-identified lesions, interactive definition of virtual resection plane and virtual needle path, and allows for regional volumetric analysis of such lesions in terms of size, position, margin, and enhancement pattern, providing information for physician's evaluation and treatment planning, monitoring, and follow-up.
The software is designed for use by trained professionals, including physicians and technicians. Image source: DICOM.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
EDDA Technology 510(k) Summary K141745 5 Independence Way Princeton, NJ 08540 Tel: 609-919-9889 Fax: 609-919-9779 Contact: Xiaolan Zeng, Executive Vice President Date prepared: September 22nd, 2014
-
- Identification of the Device: Proprietary - Trade Name: IQQA-BodyImaging Software
Classification Name: System, Image Processing, Radiological, Product Code LLZ Common/Usual Name: Radiological Image Processing System
- Identification of the Device: Proprietary - Trade Name: IQQA-BodyImaging Software
-
- Substantially equivalent legally marketed devices:
| Manufacturer | Name of the Predicate Device | FDA 510(k) Number | FDA Clearance Date |
|---|---|---|---|
| GE Medical Systems | Volume Viewer Plus | K041521 | 06/22/2004 |
| Mevis Medical Solutions | Visia Oncology | K120484 | 03/27/2012 |
| EDDA Technology | IQQA-Liver Multimodality | K131498 | 07/25/2013 |
| Intio | ClearStart SVM | K113541 | 12/16/2011 |
-
- Indications for Use (intended use):
IQQA-BodyImaging is a PC-based, self-contained, non-invasive image analysis software application for reviewing body imaging studies (including thoracic, abdominal and pelvic) derived from CT and MR scanners. Combining image viewing, processing and reporting tools, the software is designed to support the visualization, evaluation, and reporting of body imaging studies and physician-identified lesions. The software supports a workflow based on automated image registration for viewing and analyzing multiphase and multiple time-point volume datasets. It includes tools for interactive segmentation and labeling of organ segments and vascular/ductal/airway structures. The software provides functionalities for manual or interactive segmentation of physician-identified lesions, interactive definition of virtual resection plane and virtual needle path, and allows for regional volumetric analysis of such lesions in terms of size, position, margin, and enhancement pattern, providing information for physician's evaluation and treatment planning, monitoring, and follow-up. The software is designed for use by trained professionals, including physicians and technicians. Image source: DICOM.
- Indications for Use (intended use):
-
- Description of the device:
The IQQA-BodyImaging 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. The data utilized is derived from CT and MR scanners, and includes thoracic/abdominal/pelvic images.
- Description of the device:
Combining image processing, viewing and reporting tools, the software supports the visualization, evaluation and reporting of body imaging scans and physician identified lesions. Viewing tools include 2D original DICOM image viewing, window level adjustment, pre
4
defined optimized window level setting, synchronized viewing of multi-phase datasets or volumes from multiple time-points, MPR (orthogonal, oblique and curved), MIP and MinIP, volume rendering. Analysis and evaluation tools include automatic/interactive segmentation of structures utilizing user input of seeding points and bounded boxes, interactive labeling of segmented areas, user tracing and interactive editing, quantitative measurement derived from segmentation and labeling results, and the measurement of distance between physician specified structures and landmarks. Reporting tools in the software automatically assemble information including physician identified lesion locations, measurement information, physician-input lesion characterization, lesion snapshot images across multi-phases or multiple time-points, information of organ segments and vessels/ducts/airways, and illustrative snapshots of the GUI taken by physicians, for physician's confirmation and further diagnosis and patient management note input.
The IQQA-BodyImaging software supports a workflow based on automated registration for viewing and analyzing multiphase or multiple time-point volume datasets. The software automatically matches the spatial location of original DICOM images across contrasted multiphases or multiple time-points, and with physicians' interactive adjustment, to enable synchronized viewing of datasets simultaneously. Physician may also activate the temporal movie display of selected slice locations across multi-phases to aid visualization and evaluation.
After identifying and marking lesions on 2D image display, physicians can either manually trace lesion boundary or activate automated tools to segment lesion. The software further includes tools for interactive segmentation and interactive labeling of organ segments and vascular/ductal/airway structures (such as liver lobes, major branches of vessels/ducts/airways), thus facilitating the visualization of spatial relationship between suspicious lesions and specified anatomical structures/landmarks.
The software provides functionalities for interactive adjustment of user-defined margin size around the lesion, interactive definition of virtual resection plane, interactive definition of virtual needle path to lesion and local zone, regional analysis of lesions with respect to suze, shape, position, margin, and enhancement pattern etc, synchronized view of lesion and information between planning/baseline study and monitoring/follow-up studies, thus providing information to support physician's to evaluation of physician-identified lesions as well as treatment planning, monitoring and follow-up assessment.
The software is designed for use by trained professionals only (physicians, radiologists, surgeons, hospital technicians etc). Physicians make all final diagnosis and patient management decisions.
-
- Comparison with predicate devices IFU and Technological characteristics (Next page)
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| Device of 510(k) submission: | Predicate Device: Volume Viewer Plus | Predicate Device: Visia Oncology | Predicate Device: IQQA-Liver Multimodality Software | Predicate Device: ClearStart SVM | |
|---|---|---|---|---|---|
| IQQA-BodyImaging Software (version 1.0) K141745 | K041521 | K120484 | K131498 | K113541 | |
| Manufacturer | EDDA Technology | GE Medical System | Mevis Medical Solutions | EDDA Technology | Intio |
| Indications for Use | IQQA-BodyImaging is a PC-based, self-contained, non-invasive image analysis software application for reviewing body imaging studies (including thoracic, abdominal and pelvic) derived from CT and MR scanners. Combining image viewing, processing and reporting tools, the software is designed to support the visualization, evaluation, and reporting of body imaging studies and physician-identified lesions. The software supports a workflow based on automated image registration for viewing and analyzing multiphase and multiple time-point volume datasets. It includes tools for interactive segmentation and labeling of organ segments and vascular/ductal/airway structures. The software provides functionalities for manual or interactive segmentation of physician-identified lesions, interactive definition of virtual resection plane and virtual needle path, and allows for regional volumetric analysis of such | Volume Viewer Plus is medical diagnostic software that allows the processing, review, analysis and communication of 3D reconstructed images and their relationship to originally acquired images from CT, MR, X-Ray Angio and PET scanning devices. The combination of acquired images, reconstructed images, annotations and measurements performed by the clinician are intended to provide to the referring physician clinically relevant information for diagnosis, surgery and treatment planning. | Visia Oncology is a medical software application intended for the visualization of images from a variety of image devices. The system provides viewing, quantification, manipulation, communication, and printing of medical images. Visia Oncology is a noninvasive image analysis software package designed to support the physician in routine diagnostic oncology, staging and follow-up. Flexible layouts and automated image registration facilitate the synchronous display and navigation of multiple datasets for viewing data and easy follow-up comparison. The application provides a range of interactive tools specifically | IQQA-Liver Multimodality is a PC-based, self-contained, non-invasive image analysis software application for reviewing multiphase images derived from various sources (e.g. CT scanners, MR scanners). Combining image viewing, processing and reporting tools, the software is designed to support the visualization, evaluation and reporting of liver and physician-identified lesions. The software supports a workflow based on automated image registration for viewing and analyzing multiphase volume datasets. It 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, interactive definition of virtual resection plane, and allows for regional volumetric analysis of such lesions in | The INTIO ClearStartSVMTAI system is a self-contained image analysis desktop workstation addressing the needs of physicians performing diagnostic oncologic imaging, treatment planning, and post-procedure or systemic therapy follow-up assessment. ClearStartSVMNI provides semi-automated tools for segmentation of suspicious lesions including primary and metastatic lung and liver tumors, and lymph node assessment using non-contrast and contrast CT images. Following lesion segmentation, ClearStart.SVMTM'Sa utomated1 volumetric, RECIST and WHO lesion measurements provide the user with data on the time-course of patient response to therapy. An on-board large disk storage capacity allows the user to easily track each patient's CT data from initial diagnosis through therapeutic interventions and follow up exams and includes a reporting package to aid in the assessment of response to therapy. The system is password protected so that only the above mentioned trained medical |
6
| | Device of 510(k) submission:
IQQA-
BodyImaging
Software (version
1.0) K141745 | Predicate Device:
Volume
Viewer Plus
K041521 | Predicate Device:
Visia
Oncology
K120484 | Predicate Device:
IQQA-Liver
Multimodality
Software
K131498 | Predicate Device:
ClearStart SVM
K113541 |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| | lesions in terms of
size, position, margin,
and enhancement
pattern, providing
information for
physician's evaluation
and treatment
planning, monitoring,
and follow-up.
The software is
designed for use by
trained professionals,
including physicians
and technicians.
Image source:
DICOM. | | designed for
segmentation
and volumetric
analysis of
findings. The
integrated
reporting helps
the user to track
findings and
note changes,
such as shape
or size, over
time. | terms of size,
position, margin
and enhancement
pattern, providing
information for
physician's
evaluation and
treatment planning.
The software is
designed for use by
trained
professionals,
including
physicians and
technicians. Image
source: DICOM. | professionals are
authorized users. |
| Image
Modality
Input | CT, MR | CT, MR, PET,
PET/CT | From various
sources such as
CT | CT, MR | CT |
| Imaging
Coverage | Thoracic, Abdominal,
Pelvic | Thoracic,
Abdominal,
Pelvic,Neuro.
& more | Oncology
coverage in
general | Abdominal | Thoracic, Abdominal |
| Segmentation
& volumetric
analysis of
structures of
interest | Yes | Yes | Yes | Yes | Yes |
| Tracking
through
multiple
images | automated image
registration | Not specified | automated
image
registration | automated image
registration | allows user to track
each patient's CT data
from initial diagnosis
through therapeutic
interventions and
follow up exams |
| Used by | for use by trained
professionals,
including physicians
and technicians | clinician,
referring
physicians | physician | for use by trained
professionals,
including
physicians and
technicians | trained medical
professionals |
| Hardware
Configuration | standard PC hardware | standard PC
hardware | standard PC
hardware | standard PC
hardware | standard PC hardware |
| User Interface | A graphical user
interface for users to
interact with the
software, select tools
and drive workflow | A graphical
user interface
for users to
interact with
the software,
select tools and
drive workflow | A graphical
user interface
for users to
interact with
the software,
select tools and
drive workflow | A graphical user
interface for users
to interact with the
software, select
tools and drive
workflow | A graphical user
interface for users to
interact with the
software, select tools
and drive workflow |
7
IQQA-BodyImaging software has the similar intended use and technological/functional features as the predicate devices in providing tools and workflow designs to support physician users to visualize and evaluate DICOM images of selected patient studies: supporting physicians to evaluate, quantify, and document physician-identified structures of interest; being used by physicians to support own patient management decision making.
The IQQA-BodyImaging device has no patient contacting materials and is utilized only by trained professionals. The trained professionals, providing ample opportunity for competent human intervention interpret images and information being displayed. They are competent to determine whether the images provide information that can be useful in the decision of a diagnosis and patient management. Physicians make all final diagnostic and patient management decision.
IQQA-BodyImaging and predicate devices are substantially equivalent in the areas of technical characteristics, principles of operation, and functional features. The new device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices.
-
- Safety and Effectiveness:
The IOOA-BodyImaging labeling contains instructions for use and necessary cautions, warnings and notes to provide for safe and effective use of the device. Risk Management is ensured via the company's design control and risk management procedures. Potential hazards are controlled via software development and verification and validation testing.
- Safety and Effectiveness:
-
- Testing Information and Performance:
All product specifications were verified and validated. 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.
- Testing Information and Performance:
On the segmentation and measurement tools, experimental results on simulated images containing structures of interest (including ellipsoid, crescent, and cylinder shapes) to study measurement accuracy showed less than 1.5% in volume measurement difference as compared with the ground truth. In addition, to study intra-observer consistency when using the IQOA-BodyImaging interactive segmentation and measurement tools, retrospective clinical patient studies of CT and MR modalities for the thoracic, abdominal and pelvic body parts were used -the mean volume measurement differences by two physicians were 0.4%, 1.5% and 2.5%, respectively.
On the registration tools, experiments involving phantom image pairs scanned at different times with different positioning and orientations, and retrospectively collected patient studies scanned at different times during clinical practice were conducted. The results showed a mean interactive registration error of 0.2394mm with a standard deviation of 0.2261mm on phantom studies scanned at different times with different positioning and orientations, a mean initial automated
8
registration error of 0.5594mm with a standard deviation of 0.5448mm on patient studies with synthetic deformations, and a mean interactive registration error of 0.5388mm with a standard deviation of 0.7150mm on retrospective patient studies that are scanned at different times during clinical practice.
Additionally, to supplement the software validation for IQQA-BodyImaging, the company has conducted software testing at two clinical sites. The purpose of the testing is to have physicians use the IQOA-BodyImaging software application to review CT and MR body imaging scans. validate major functionalities provided by the system, and provide feedback along the line of the intended use of the system.
Conclusion 8.
The IQQA-BodyImaging software package has the same intended use as the predicate devices. Test results demonstrate that the device is safe, effective, and does not raise any new potential safety risks. In all material respects, the IQQA-BodyImaging software tool is substantially equivalent to the predicate devices.