Multi-Modality Image Fusion is a software application to be used by physicians in the clinic or hospital for 2-D and 3-D visualization, image registration, and fusion of MRI, CT and Ultrasound imaging modalities for mapping planning information across modalities. Additional software features include database management, data communication, surface rendering, segmentation, regions of interest (ROI) delineation, volumetric measurements, and data reporting.

Device Description

Multi-Modality Image Fusion (MMIF) is software, which comprises of two software components, which is referred to as offline and online. The offline component perfains to the preparation of gland and suspected lesion boundaries on a DICOM image file days or hours prior to the biopsy procedure. The online component fuses the DICOM image files, which were, prepared on the offline component, with a snap shot incoming TRUS image. Each of the two software components can work together or independently.

AI/ML Overview

The provided 510(k) summary for the Multi-Modality Image Fusion device does not contain a specific table of acceptance criteria or detailed results of a study proving the device meets those criteria. However, it does outline the types of tests performed and provides a general statement of success.

Based on the available information, here is a description of the acceptance criteria (inferred from the testing) and the study conducted:

1. Acceptance Criteria and Reported Device Performance

Since explicit acceptance criteria are not provided, they are inferred from the types of tests performed. The document states that "All product and engineering specifications were verified and validated" and that "All the above mentioned tests passed." This implies that the device successfully met the intended performance parameters for each test.

Acceptance Criteria (Inferred from Tests)	Reported Device Performance
Functional/Hardware Verification	Tests Passed
- Hardware Verification	Successfully verified the MMIF hardware.
- Online Software Application Verification	Successfully verified the online software application.
- Offline Software Application Verification	Successfully verified the offline software application.
Risk Mitigation Verification	Tests Passed
- Risk Mitigation Verification	Successfully verified risk mitigation strategies.
Accuracy (Benchmarking)	Tests Passed
- Registration Accuracy for Clinical Data	Demonstrated accuracy in registration for clinical data.
- Phantom Volume Measurements	Demonstrated accurate volume measurements using phantoms.
- Phantom Registration Accuracy	Demonstrated accurate registration using phantoms.
System Performance (Static & Dynamic)	Tests Passed
- Overall System Performance	Confirmed static and dynamic performance of the complete system (both online and offline software on specified hardware) and compliance to specifications in a simulated real environment.

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

The document mentions "clinical data collected from the hospital setting" for the "Registration Accuracy for Clinical Data (bench test)." However, the sample size for this test set (number of cases/patients) is not specified. The data provenance is generally stated as "clinical data collected from the hospital setting," indicating it is likely retrospective clinical data used for a bench test.

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

The document does not specify the number of experts used or their qualifications for establishing the ground truth of the "clinical data" used in testing. It only mentions that the "offline software would be typically executed by Radiologists."

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth on the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not mentioned or described in the provided summary. The focus of the performance testing appears to be on the device's standalone accuracy and functionality.

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

Yes, a standalone performance evaluation of the algorithm (referred to as "the new MMIF software") was performed. The "Testing and Performance Data" section describes "bench testing" activities conducted "to ensure the performance of the new MMIF software by verifying the accuracy of the specifications and simulating real customer data collected from the hospital setting." The registration accuracy and volume measurements were assessed for the software itself.

7. The Type of Ground Truth Used

The ground truth for the bench tests involved:

Simulated prostates in test phantoms: Used for "Phantom Volume Measurements" and "Phantom Registration Accuracy." This represents a controlled and precisely known ground truth.
"Clinical data collected from the hospital setting": Used for "Registration Accuracy for Clinical Data." The method for establishing ground truth for this clinical data (e.g., expert consensus, pathology, surgical outcomes) is not explicitly stated.

8. The Sample Size for the Training Set

The document does not specify a training set size. The summary focuses on device verification and validation, implying that the device was perhaps developed or configured based on various data, but the specific characteristics of a "training set" (in the machine learning sense) are not outlined.

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

Since a training set is not explicitly mentioned, the method for establishing its ground truth is not provided. The device seems to be a software application for image processing and fusion, rather than a machine learning model that requires explicit training data in the context of this 510(k) summary. For software applications of this nature, ground truth is often implicitly established by the underlying physical principles of image registration algorithms and validated against physical models or existing clinical standards.

Summary

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510(k) Summary

APR - 6 2012

510(k) Summary

Submitter's Name: Submitter's Address: Submitter's Telephone: Contact Name:

Date Summary was Prepared: Trade or Proprietary Name: Common or Usual Name: Classification Name:

Predicate Devices:

IGT, LLC dba Eigen 13366 Grass Valley Avenue, Grass Valley, CA 95945 530-274-1240 . William Mandel 21 Oct 2011

Multi-Modality Image Fusion Multi-Modality Image Fusion

System, Image Processing, Radiological, LLZ

Picture Archiving and Communications, 21CFR 892.2050

Device Name	510(k) Number
Syntegra	K041182
UniSyn	K081987
Aegis Navigation	K093672
Abaris	K053610

Intended Use

Description of the Device and Summary of the Technological Characteristics:

Offline Software

The offline software can delineate suspected areas of interest using visualization and save this data in a standard format, e.g. as a surface mesh in VTK or STL format. Furthermore, the

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offline software can ontionally delineate the gland boundary from a DICOM image, or other volumes where the boundary can be easily observed. This addition data is also saved in a standard format. e.g. surface mesh in VTK or STL or as a binary volume. This software would be typically executed by Radiologists.

Online Software

The online unit software is designed to fuse two images by entering a fusion mode and load the DICOM image and the boundary data provided by the offline unit. The online unit performs rigid alignment, either selecting globally align that orients the two DICOM volumes based on the known relative orientation difference between the two or specify landmarks to register images rigidly. The online unit then elastically warps the image to register on the incoming image from the offline unit.

The registered image volume is displayed on the incoming offline image frame of reference. Also overlaid on the incoming offline and registered image volumes annotating the suspected lesion boundaries. The two volumes are displayed side-by-side in a locked view. Rotation, slicing, panning, or zooming one of the volumes has the same effect on the other enabling visualization of similar features in both volumes simultaneously.

Plan targets on the volumes by selecting suitable locations within the suspected areas of interest boundary. When sufficient targets have been added, exiting fusion mode imports all targets planned in the offline frame of reference back to the original reconstructed ultrasound volume. This is done based on the deformation field that was estimated from registration (rigid followed by elastic registration).

Substantial Equivalence:

Manufacturer	Eigen	ADACLaboratories	ConvergentImagingSolutions	Sentinelle MedicalInc.	TraxtalTechnologies lhc.
ProductName	Multi-ModalityImage Fusion	Syntegra	UniSyn	Aegis Navigation	Abaris
510(k)number	pending	K041182	K081987	K093672	K053610
IntendedUse	Multi-ModalityImage Fusion is asoftwareapplication used by	Syntegra is asoftwareapplication formulti-modality	UniSyn is asoftwareapplication forimage	This deviceprovides two andthree-dimensionalimage review.	ABARIS is astereotaxicaccessory forComputed

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physicians in the	image registration	registration and	manipulation, and	Tomography
clinic or hospital	and diagnostic	fusion display	analysis tools to	(CT), Magnetic
for 2-D and 3-D	fusion. Images are	of scanned	assist users in	Resonance, (MR),
visualization,	registered and	image data	screening,	Ultrasound (US),
multi-modality	displayed in a	from CT, PET,	diagnosis, planning	Positron Emission
image registration,	"fused" (overlaid	SPECT and	and performing	Tomography
and fusion of	in the same spatial	MR scanners.	image-guided	(PET), Single
medical images.	orientation)	UniSyn creates	interventional	Photon Emission

Additional	format to provide	multi-planar	procedures.	Computed
software featuresinclude database	combined	reformat and	Supported imaging	Tomography
	functional and	maximum	modalities include	(SPECT),
management,	anatomical data	intensity	Magnetic	Fluoroscopy,
communication.	providing	projection	Resonance (MR),	Endoscopy and
surface rendering,	different angular	displays of the	Ultrasound (US),	other imaging
segmentation, ROI	perspectives for	data and	Single Photon	systems. it
delineation,	interpretation by	provides	Emission	displays the
measurements, and	trained	measurements	Computed	simulated image
reporting.	professionals	such as area,	Tomography	of a tracked
		volume and	(SPECT),	insertion tool
		Standard	Computed	such as a biopsy
		Uptake Values	Tomography (CT),	needle, guidewire
		for user defined	Positron	or probe on a
		regions on the	Emission	computer monitor
		image	Tomography	screen that shows
			(PET),	images of the
			Fluoroscopy and	target organs and
			Endoscopy. Images	the current and the
			and data are	projected future
			received from	path of the
			various imaging	interventional
			systems and other	instrument taking
			sources such as	into account
			calibrated spatial	movements of the
			positioning	patient. This is
			devices.	intended for
			This device	treatment
			provides the	planning and
			capability to	intra-operative
			overlay annotations	guidance for
			on 2D or 3D	surgical
			medical image	procedures.
			displays.	The device also
			These annotations	supports an
			may represent the	image-free mode
			position of	in which the
			instruments	proximity of the
			including but not	interventional
			limited to biopsy	device is
			needles, guidance	displayed relative
			wires, imaging	to another device.
			probes or other	The device is
			tracked devices.	intended to be
			This device is	used in clinical
			intended to assist	interventions and
			skilled medical	for anatomical
			professionals in	structures where
					skilled medicalprofessionals inclinical screeningand	clinical screening	for anatomicalstructures whereimaging iscurrently used for	imaging is

510(k) Summary

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				510(k) Summary

				interventions, foranatomicalstructures whereimaging iscurrently used forvisualizing suchstructures,including head andneck, breast,thoracic, andabdominalapplications(including	visualizing suchprocedures. Thedevice is alsointended for usein clinicalinterventions todetermine theproximity ofone devicerelative toanother.
				pelvis).Lossy compressedmammographicimages anddigitized filmscreen images mustnot be
				reviewed forprimary imageinterpretations.Mammographicimages may onlybe interpretedusing
				a FDA approvedmonitor that offersat least 5 MPixelresolution andmeets othertechnical
				specificationsreviewed andaccepted by theFDA.
WhereUsed	Office settings inclinic or hospital	Office settings inclinic or hospital	Office settingsin clinic orhospital	Not specified	clinicalinterventions
SoftwareDevice	Yes	Yes	Yes	Yes	Yes
ImageRegistration	Multi-modalityimage registration	Multi-modalityimage registration	Multi-modalityimageregistration	Multi-modalityimage registration	Yes
ImageFusion/OverlayDisplay	Fused overlay ofimages frommultiple modalities	Fused overlay ofimages frommultiplemodalities	Fusion overlayof images frommultiplemodalities	overlay of imagesfrom multiplemodalities	Yes
OpacityControl	Yes	Yes	Yes	Not Specified	Not Specified
3-DRendering	Yes	Yes	Yes	Yes	Yes
SurfaceRendering	Yes	Yes	Yes	Yes	Yes
Regions ofinterest	Yes	Yes	Yes	Yes	Yes
Configura	Yes	Yes	Yes	Yes	Yes

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510(k) Summary

ble image layouts
3DContouring	Yes	Not Specified	Yes	Yes	Yes
Export of3D contoursforplanning	Yes	Not Specified	Yes	Not Specified	Yes
ImageStorageandCommunication	DICOM, JPEG	DICOM (check)	DICOM	DICOM	DICOM
Modalities	CT, MRI,Ultrasound	Positron EmissionTomography(PET) andX-ray ComputedTomography(CT).	CT, PET,SPECT andMR scanners	MRI, US, SPECT,CT, PET,Fluoroscopy,Endoscopy andothers	ComputedTomography(CT), MagneticResonance, (MR),Ultrasound (US),Positron EmissionTomography(PET), SinglePhoton EmissionComputedTomography(SPECT),Fluoroscopy,Endoscopy andother imaging

The product's technical features are substantially equivalent to Syntegra (K041182). UniSyn (K081987), Aegis Navigation (K093672) and Abaris (K053610). The Multi-Modality Image Fusion is a software product that runs on PC-based workstations. Image data is input to the devices and used to generate 3-D views and perform image processing. Like the four predicate devices, the software has image measurement, multi-planar reformatting, segmentation and image registration abilities, fusion of images from different modalities, image storage and retrieval, as well as patient information management functions.

The Syntegra and UniSyn are software products that accept multiple image data types including magnetic resonance, and computed tomography. Aegis Navigation and Abaris are systems that accept multiple modalities that include magnetic resonance, computed tomography and ultrasound. The Multi-Modality Image Fusion has been designed for processing medical images in standard DICOM format. The system is composed of two modules: an offline and an online module for image fusion for planning a procedure.

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Testing and Performance Data:

All product and engineering specifications were verified and validated. Test phantoms incorporating simulated prostates were developed and were used to verify system performance.

The device has been designed and manufactured to conform to the following standards:

ACRINEMA PS3.1-3.18 Digital Imaging and Communications in Medicine (DICOM)

ISO 14971 Application of Risk Management to Medical Devices

ISO 13485 Medical Devices - Quality Management Systems - Requirements For Regulatory purposes

The following tests were performed:

MMIF Hardware verification Test Procedure

MMIF Online Verification Test Procedure

MMIF Offline Software Application Verification Test Procedure .

MMIF Risk Mitigation Verification Test Procedure

Registration Accuracy for Clinical Data (bench test)

Phantom Volume Measurements (bench test)

Phantom Registration Accuracy (bench test)

All the above mentioned tests passed. Theses testing activities were conducted to establish the performance, safety, effectiveness, functionality usability, and reliability characteristics of the new device.

The purpose of the performance testing (bench testing) was to ensure the performance of the new MMIF software by verifying the accuracy of the specifications and simulating real customer data collected from the hospital setting.

The conducted verification tests have confirmed static and dynamic performance of the complete system consisting of both the online and off line software installed on specified hardware. Furthermore these tests establish compliance to the specification under conditions simulation real environment of use.

Conclusion:

The results of comparing the intended use, function, technological characteristics, mode of operation and specifications of the Multi-Modality Image Fusion with those of the two predicate devices demonstrate that the Multi-Modality Image Fusion is substantially

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equivalent to existing products on the market today.

. . . .

ﺎ ﺳﮯ ﺍ

1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -

The verification and validation testing included bench performance tests, functionality tests, and system test. All tests were successfully completed.

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Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

APR - 6 2012

IGT LCC dba Eigen % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services 1394 25th Street NW BUFFALO MN. 55313

Re: K120187

Trade/Device Name: Multi-Modality Image Fusion Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications System Regulatory Class: II Product Code: LLZ Dated: March 1, 2012 Received: March 2 2012

Dear Mr. Job:

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 class II (Special Controls), it may be subject to such additional controls: Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 or uny 1 vict all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known):

Device Name: Multi-Mogality Image Fusion

Indications for Use: Multi-Modality Image Fusion is a software application to be used by physicians in the clinic or hospital for 2-D and 3-D visualization, image registration, and fusion of MRI, CT and Ultrasound imaging modalities for mapping planning information across modalities. Additional software features include database management, data communication, surface rendering, segmentation, regions of interest (ROI) delineation, volumetric measurements, and data reporting.

Prescription Use (Part 21 CFR 801 Subpart D)	X
	AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety

510(k) K120187

1-2

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).