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.

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, pre-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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a table format with pass/fail thresholds. Instead, it reports performance metrics from various tests. I will present the reported performance as if these were the evaluation metrics against which the device's performance was assessed.

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Volumetric Measurement Accuracy (on simulated images)	Minimizing difference compared to ground truth.	Less than 1.5% in volume measurement difference as compared with the ground truth for simulated images (ellipsoid, crescent, cylinder shapes).
Intra-observer Consistency (mean volume measurement difference by two physicians)	Minimizing difference between observers.	For retrospective clinical patient studies of CT and MR modalities (thoracic, abdominal, pelvic):- Thoracic: 0.4%- Abdominal: 1.5%- Pelvic: 2.5%
Interactive Registration Error (phantom studies)	Minimizing registration error.	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.
Initial Automated Registration Error (patient studies with synthetic deformations)	Minimizing registration error.	Mean initial automated registration error of 0.5594mm with a standard deviation of 0.5448mm on patient studies with synthetic deformations.
Interactive Registration Error (retrospective patient studies)	Minimizing registration error.	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.
Major Functionality Validation	N/A (Qualitative feedback)	Software testing conducted at two clinical sites; physicians used the software to review CT and MR body imaging scans, validate major functionalities, and provide feedback along the line of intended use.
Overall Safety and Effectiveness	Device is safe and effective; no new safety risks.	"The IQQA-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." "Test results demonstrate that the device is safe, effective, and does not raise any new potential safety risks."
Substantial Equivalence	Equivalent to predicate devices in technical characteristics, principles of operation, and functional features, without new safety risks.	"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."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a single number for all tests.
- Simulated images: An unspecified number of simulated images described as containing "ellipsoid, crescent, and cylinder shapes."
- Retrospective clinical patient studies: An unspecified number of "clinical patient studies" of CT and MR for thoracic, abdominal, and pelvic body parts.
- Phantom image pairs: An unspecified number of "phantom image pairs scanned at different times with different positioning and orientations."
- Patient studies with synthetic deformations: An unspecified number of "patient studies with synthetic deformations."
- Retrospective patient studies for registration: An unspecified number of "retrospective patient studies that are scanned at different times during clinical practice."
Data Provenance:
- Simulated images: Artificially generated (simulated).
- Clinical Patient Studies (for intra-observer consistency): Retrospective, specific country of origin not mentioned, but described as "clinical patient studies."
- Phantom Studies (for registration): Acquired from physical phantoms, specific country/institution not mentioned.
- Patient Studies (for automated and interactive registration): Retrospective, specific country of origin not mentioned, but described as "patient studies."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts:
- For intra-observer consistency in volume measurement validation, "two physicians" were used.
- For clinical site validation/feedback, "physicians" at "two clinical sites" were involved, but the specific number involved in establishing ground truth for the performance metrics is not detailed.
Qualifications of Experts: The document states "physicians" were used. No further details about their specific qualifications (e.g., specialty, years of experience, subspecialty) are provided.

4. Adjudication Method for the Test Set

Intra-observer consistency: Implies a comparison between the measurements of two physicians, not necessarily an adjudication to establish a "ground truth" but rather to assess agreement between human operators using the device.
For other tests where "ground truth" is mentioned (e.g., volumetric measurement accuracy on simulated images, registration error relating to phantom studies), the method of establishing this ground truth is not specified as an adjudication process. The ground truth for simulated images would be known by design. For phantom studies, it's typically based on physical measurements or precise setup parameters.
No specific adjudication method like "2+1" or "3+1" is described.

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

No MRMC comparative effectiveness study is described in the provided text. The document focuses on the performance of the software's sub-components (segmentation, measurement, registration) and intra-observer consistency when physicians use the tools.
There is no mention of comparing human readers with AI assistance versus without AI assistance to measure an effect size of improvement. The device is positioned as a tool to support physician evaluation, not explicitly to replace or augment their accuracy in a comparative study.

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

Yes, partially.
- The "Volumetric Measurement Accuracy" test on simulated images would likely represent a standalone performance evaluation against a known ground truth.
- The "Initial Automated Registration Error" on patient studies with synthetic deformations also appears to be a standalone measurement of the algorithm's performance before any interactive adjustment.
However, other tests, like "Intra-observer Consistency" and "Interactive Registration Error," specifically involve human interaction with the device.

7. The Type of Ground Truth Used

Simulated Images: "Ground truth" was established by the design of the simulated objects (ellipsoid, crescent, cylinder shapes).
Phantom Studies (for registration): "Ground truth" would likely be derived from the known physical properties or precise measurements of the phantom and its setup.
For clinical patient studies (intra-observer consistency and general registration performance), the "ground truth" for the observed differences is not explicitly described as pathology or outcomes data. Instead, the evaluations focus on consistency between human measurements or the accuracy of the software against a reference (which for patient studies might be a manual measurement considered as the reference standard, though not specified).

8. The Sample Size for the Training Set

Not provided. The document describes validation and testing, but it does not mention the sample size used for training the algorithms within the IQQA-BodyImaging Software.

9. How the Ground Truth for the Training Set Was Established

Not provided. Since the training set sample size is not mentioned, neither is the method for establishing its ground truth.

Summary

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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.

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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

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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)

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)

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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

1. 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
1. 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

1. 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.
1. 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.

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

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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.

1. 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

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	Device of 510(k) submission:IQQA-BodyImagingSoftware (version1.0) K141745	Predicate Device:VolumeViewer PlusK041521	Predicate Device:VisiaOncologyK120484	Predicate Device:IQQA-LiverMultimodalitySoftwareK131498	Predicate Device:ClearStart SVMK113541
	lesions in terms ofsize, position, margin,and enhancementpattern, providinginformation forphysician's evaluationand treatmentplanning, monitoring,and follow-up.The software isdesigned for use bytrained professionals,including physiciansand technicians.Image source:DICOM.		designed forsegmentationand volumetricanalysis offindings. Theintegratedreporting helpsthe user to trackfindings andnote changes,such as shapeor size, overtime.	terms of size,position, marginand enhancementpattern, providinginformation forphysician'sevaluation andtreatment planning.The software isdesigned for use bytrainedprofessionals,includingphysicians andtechnicians. Imagesource: DICOM.	professionals areauthorized users.
ImageModalityInput	CT, MR	CT, MR, PET,PET/CT	From varioussources such asCT	CT, MR	CT
ImagingCoverage	Thoracic, Abdominal,Pelvic	Thoracic,Abdominal,Pelvic,Neuro.& more	Oncologycoverage ingeneral	Abdominal	Thoracic, Abdominal
Segmentation& volumetricanalysis ofstructures ofinterest	Yes	Yes	Yes	Yes	Yes
Trackingthroughmultipleimages	automated imageregistration	Not specified	automatedimageregistration	automated imageregistration	allows user to trackeach patient's CT datafrom initial diagnosisthrough therapeuticinterventions andfollow up exams
Used by	for use by trainedprofessionals,including physiciansand technicians	clinician,referringphysicians	physician	for use by trainedprofessionals,includingphysicians andtechnicians	trained medicalprofessionals
HardwareConfiguration	standard PC hardware	standard PChardware	standard PChardware	standard PChardware	standard PC hardware
User Interface	A graphical userinterface for users tointeract with thesoftware, select toolsand drive workflow	A graphicaluser interfacefor users tointeract withthe software,select tools anddrive workflow	A graphicaluser interfacefor users tointeract withthe software,select tools anddrive workflow	A graphical userinterface for usersto interact with thesoftware, selecttools and driveworkflow	A graphical userinterface for users tointeract with thesoftware, select toolsand drive workflow

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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.

1. 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.
1. 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.

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

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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.

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).