UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT and MR scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.

Device Description

UniSyn is a software only package designed for use on Intel Pentium and higher compatible computers running Microsoft Windows XP and later operating systems. It loads and writes images using a proprietary format.

UniSyn provides the following features:

manual registration of images, where users can use user interface widgets to align the images in three dimensions;
automated registration of images from hybrid PET-CT and SPECT-CT scanners, which provide the registration parameters in their image headers;
multi-planar reformat (MPR) and image triangulation using cursors: linked transverse, sagittal and coronal views. When the user moves a cursor on one view, the corresponding orthogonal planes of the image are computed and displayed on the other.
image fusion with variable opacity
Maximum Intensity Projection (MIP)
3D Render
Surface Render
2D regions of interest and 2D statistics such as area
3D volumes of interest and 3D statistics such as volume, average Standard Uptake Value (SUV) and maximum SUV
user configurable layouts: type of image (ie which modality and what type of display: one of MIP, MPR/), size, color map, position - can be preconfigured;
triangulation from MIP image: if the user clicks on the MIP image when it is in the coronal view, the MPR/fusion displays will update their position to that point
color maps individually assigned for fusion and non-fusion views
screen capture to clipboard and to disk

AI/ML Overview

The provided text for KO81997 does not contain the detailed information necessary to complete a table of acceptance criteria and reported device performance, nor does it describe a study that explicitly proves the device meets specific acceptance criteria in the manner requested.

Instead, this document is a 510(k) summary for a medical device (UniSyn) seeking clearance based on substantial equivalence to predicate devices, rather than comprehensive performance testing against numerical acceptance criteria.

However, based on the information provided, I can infer some aspects and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for UniSyn does not define explicit "acceptance criteria" in a quantitative sense (e.g., accuracy percentages, sensitivity/specificity thresholds) or report device performance against such criteria. The document focuses on demonstrating substantial equivalence to predicate devices by comparing features.

Here's an attempt to structure a table based on the provided information, emphasizing the comparison to predicates as the "performance" described:

Feature/Criterion	Predicate Device(s) (Syntegra, Medical Image Merge) Performance/Presence	UniSyn Performance/Presence	Basis for "Meeting Criteria"
Software Device	✓ (Present)	✓ (Present)	Identical feature.
Intended Use	Similar	Similar	Similar.
Multimodality Registration	✓ (Present)	✓ (Present)	Identical feature.
Multimodality Fusion Display	✓ (Present)	✓ (Present)	Identical feature.
Fusion Opacity Control	✓ (Present)	✓ (Present)	Identical feature.
Regions of Interest	✓ (Present)	✓ (Present)	Identical feature.
Standard Uptake Value Calc.	✓ (Present)	✓ (Present)	Identical feature.
Multiplanar Reformat with Triangulation	✓ (Present)	✓ (Present)	Identical feature.
Maximum Intensity Projection (MIP)	✓ (Present)	✓ (Present)	Identical feature.
3D (Surface) Render	✓ (Present)	✓ (Present)	Identical feature.
Variable Color Maps	✓ (Present)	✓ (Present)	Identical feature.
Configurable Image Pres. Layouts	✓ (Present)	✓ (Present)	Identical feature.
PC Hardware Compatibility	✓ (Present)	✓ (Present)	Identical feature.
Automated Registration (patient outlines/fiducial markers)	✓ (Present on Syntegra, not on Medical Image Merge)	✗ (Absent)	Difference noted, but cleared as substantially equivalent.
Export of 3D contours for treatment planning	✓ (Present on Syntegra)	✗ (Absent)	Difference noted, but cleared as substantially equivalent.

Important Note: The "acceptance criteria" here are implicitly "having features substantially equivalent to the predicate devices." The document explicitly states: "UniSyn is substantially equivalent to the predicate devices Syntegra and Medical Image Merge, in terms of its image processing and display capability. UniSyn does not introduce any new features or issues of safety and effectiveness."

The following information is largely not present in the provided 510(k) summary for KO81997. The document is for a software device seeking clearance based on substantial equivalence, which typically does not require extensive clinical studies or detailed performance metrics against ground truth like a novel diagnostic algorithm might.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The document does not describe a specific test set or data used for performance evaluation in the context of clinical accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not provided. Ground truth establishment for a test set is not discussed as no such test set for performance evaluation is detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided. No test set or adjudication method 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

Not conducted/described. This device is an image processing and display software for image fusion, not a diagnostic AI algorithm intended to assist human readers in a comparative effectiveness study. Its purpose is to present existing image data in a fused format, similar to its predicates.

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

Not applicable/described as a standalone performance study. The device is software for image manipulation and display, which inherently relies on user input for tasks like manual registration and region of interest definition. Its "performance" is in its ability to execute these functions as expected, similar to the predicates.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not provided/applicable. Given the nature of the device (image processing/fusion software) and the 510(k) pathway, these types of ground truth for performance evaluation are not discussed. The "ground truth" for this type of device would likely be its success in accurately performing image registration and display functions, which is assessed through technical verification and validation, rather than clinical outcome data.

8. The sample size for the training set

Does not apply / Not provided. The document does not describe a "training set" in the context of machine learning or AI. UniSyn is described as software that performs image registration and display functions based on programmed algorithms, not trained models.

9. How the ground truth for the training set was established

Does not apply / Not provided. As there is no described training set, there is no mention of how ground truth would be established for it.

Summary

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KO81997

CONVERGENT IMAGING SOLUTIONS

UniSyn 510(k) Summary of Safety and Effectiveness July 2, 2008

510(k) Summary of Safety and Effectiveness

(APPENDIX II)

1. Submitted by:	Convergent Imaging Solutions49 First Avenue, Suite BOttawa, Ontario K1S 2G1, Canada
SEP 2 6 2008

1. Date of Preparation: July 02, 2008

3. Name, Title and Phone Number of Contact

Mathew A. Thomas
Phone: 613-239-0421	Fax, 801-315-9085

4. Tradename and Common Name of the Device

Tradename:	UniSyn
Common Name:	Image Processing (Image Fusion)Software

5. Intended Use

6. Device Description

UniSyn provides the following features:

� manual registration of images, where users can use user interface widgets to align the images in three dimensions;
automated registration of images from hybrid PET-CT and SPECT-CT scanners, . which provide the registration parameters in their image headers;
multi-planar reformat (MPR) and image triangulation using cursors: linked . transverse, sagittal and coronal views. When the user moves a cursor on one view, the corresponding orthogonal planes of the image are computed and displayed on the other.
. image fusion with variable opacity
. Maximum Intensity Projection (MIP)
� 3D Render

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Convergent Imaging SOFUTIONS

UniSyn 510(k) Summary of Safety and Effectiveness July 2. 2008

. Surface Render
2D regions of interest and 2D statistics such as area .
3D volumes of interest and 3D statistics such as volume, average Standard Uptake ● Value (SUV) and maximum SUV
user configurable layouts: type of image (ie which modality and what type of . display: one of MIP, MPR/), size, color map, position - can be preconfigured;
triangulation from MIP image: if the user clicks on the MIP image when it is in the coronal view, the MPR/fusion displays will update their position to that point
color maps individually assigned for fusion and non-fusion views .
screen capture to clipboard and to disk ●

7. Predicate Device:	Common Name:	Syntegra Image Fusion
	Manufacturer: Philips Medical Systems
	510K#:	K041182

Comon Name: Medical Image Merge (Image Fusion) Manufacturer: Syntermed (now MIM Vista) K001276

8. Technological Comparison to Predicate Devices:

510K#:

Feature	Syntegra	MedicalImage Merge	UniSyn	Comments
software device	✓	✓	✓
intended use				Similar.
multimodality registration	✓	✓	✓	Identical feature.
multimodality fusion display	✓	✓	✓	Identical feature.
fusion opacity control	✓	✓	✓	Identical feature.
Regions of Interest	✓	✓	✓	Identical feature.
Standard Uptake Value Calculation	✓	✓	✓	Identical feature.
Multiplanar reformat with triangulation	✓	✓	✓	Identical feature.
Maximum Intensity Projection	✓	✓	✓	Identical feature.
3D (Surface) Render	✓	✓	✓	Identical feature.
Variable color maps	✓	✓	✓	Identical feature.
configurable image presentation layouts	✓	✓	✓	Identical feature.
PC hardware	✓	✓	✓	Identical feature.
automated registration using patientoutlines and fiducial markers	✓
export of 3D contours for treatmentplanning	✓

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Convergent Imaging SOI UTIONS

UniSyn 510(k) Summary of Safety and Effectiveness July 2, 2008

Conclusion:

UniSyn is substantially equivalent to the predicate devices Syntegra and Medical Image Merge, in terms of its image processing and display capability. UniSyn does not introduce any new features or issues of safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of what appears to be a bird or abstract human figure, composed of three curved lines that converge at the bottom.

SEP 2 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Mathew A. Thomas Convergent Imaging Solutions 49 First Avenue, Suite B OTTAWA ONTARIO K1S 2G1 CANADA

Re: K081987

Trade/Device Name: UniSyn Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communication System Regulatory Class: II Product Code: LLZ Dated: August 25, 2008 Received: September 2, 2008

Dear Mr. Thomas:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jaque In Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

( APPENDIX III)

510K Number (if known):	K081987
DEVICE NAME:	UniSyn
SUBMITTER NAME:	CONVERGENT IMAGING SOLUTIONS

INDICATIONS FOR USE:

UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT and MR scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planer reformand maximum intensity projection displays of the data and provides measurements such an area, volume and Standard Uptake Values for user defined regions on the image.

(Please do not write below this line. Continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Over-The-Counter Use

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

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).