Synapse 3D Cardiac Tools is medical imaging software used with Synapse 3D Base Tools that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Cardiac Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, NM, and XA.

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Addition to the tools in Synapse 3D Base Tools, Synapse 3D Cardiac Tools provides the tools for specific clinical applications which provide targeted workflows, custom Ul, targeted measurements and reporting functions including:

Functional cardiac analysis for CT left ventriculography images: which is intended to evaluate the functional characteristics of heart
Functional cardiac analysis for non-contrast MR heart images: which is intended to evaluate the functional characteristics of heart
Coronary artery analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries
Coronary artery analysis for MR heart images: which is intended for the qualitative and quantitative analysis of coronary arteries
Calcium scoring for non-contrast CT heart images: which is intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms
Cardiac Fusion: which is intended to analyze cardiac anatomy and pathology with a fused image of functional data (e.g. NM image, Bulls eye) and anatomical data.

Device Description

Synapse 3D Cardiac Tools (V3.0) is the updated version of previously-cleared Synapse 3D Cardiac Tools software (cleared by CDRH via K103465 on 01/31/2011).
Synapse 3D Cardiac Tools is used in addition to the Synapse 3D Base Tools (K120361, cleared on April 6, 2012) to analyze the images acquired from CT and MR. Synapse 3D Cardiac Tools is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning of DICOM compliant medical images. This product is not intended for use with or for the primary diagnostic interpretation of mammography images.

Synapse 3D Cardiac Tools (V3.0) is an application that supports the cardiac function, cardiac fusion, and coronary artery analysis of both the computed tomography (CT) and magnetic resonance (MR) images. Synapse 3D Cardiac Tools also supports the calcium scoring for noncontrast CT images.

AI/ML Overview

The provided text describes the Synapse 3D Cardiac Tools (V3.0) and its substantial equivalence to a predicate device, but it does not include specific acceptance criteria or details of a study (e.g., performance metrics, statistical analysis) that proves the device meets those criteria.

Instead, the document states: "Synapse 3D Cardiac Tools is tested successfully with reference to its Software Requirements Specification, as well as design verification and validation documents and Traceability Matrix document. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the Synapse 3D Cardiac Tools software, which is found to be safe and effective and substantially equivalent to the currently-cleared predicate device."

Therefore, I cannot provide the requested table or detailed study information. I can only infer what the general approach to testing was.

Based on the provided text, here is what can be extracted and what information is not available:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Compliance with Software Requirements Specification	Tested successfully
Performance characteristics	Established, deemed safe and effective
Functionality characteristics	Established, deemed safe and effective
Reliability characteristics	Established, deemed safe and effective
Substantial equivalence to predicate device (K103465) for cardiac function (CT/MR), coronary artery analysis (CT), calcium scoring, and cardiac fusion	Demonstrated for V3.0 (including new MR Coronary Artery analysis)

Note: The document only states that testing was "successful" and that characteristics were "established." It does not provide quantitative metrics for device performance against specific targets.

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not specified.
Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "images acquired from CT and MR" but provides no details on how these images were assembled for testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of experts: Not specified.
Qualifications of experts: Not specified.

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

Adjudication method: Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

MRMC study: Not mentioned or implied. The document focuses on the software's functionality and substantial equivalence rather than comparative effectiveness with human readers.

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

Standalone performance: The testing described focuses on the device's adherence to its specifications rather than a specific standalone performance study with defined metrics against a ground truth. The device is a "medical image processing and analysis software" intended to provide "tools to aid them [trained medical professionals] in reading, interpreting, reporting, and treatment planning," suggesting it's designed as an aid, not a standalone diagnostic.

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

Type of ground truth: Not specified. Given the nature of the application (cardiac function, coronary artery analysis, calcium scoring), it would typically involve comparisons to established clinical measurements or expert interpretations, but the document does not elaborate.

8. The sample size for the training set:

Sample size for training set: Not specified. There is no mention of a "training set" as the device is presented as an updated version of a previously cleared software, implying its development might predate or not entirely rely on modern machine learning training paradigms in the same explicit way.

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

How ground truth was established for training set: Not specified.

In summary: The provided 510(k) summary focuses on the device description, its indications for use, its technological characteristics (primarily stating no new safety/efficacy issues compared to predicates), and that it underwent successful verification and validation against its Software Requirements Specification to demonstrate substantial equivalence. It lacks the detailed performance study information typically found in submissions for AI/ML devices requiring specific performance metrics against a robust ground truth.

Summary

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5. 510(k) Summary

Date Prepared:

February 28, 2012

Submitter's Information:

FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, Connecticut 06902

Telephone: (301) 251-1092 Fax: (203) 602-3785

Contact: Jyh-Shyan Lin

Device Trade Name:

Synapse 3D Cardiac Tools

Device Common Name:

Medical Image Processing and Analysis Software

Regulation Number:

21 CFR 892 2050

Device Classification:

Class II

Device Classification Name :

Picture Archiving and Communications System (PACS)

Panel:

Radiology

Product Code:

LLZ

Date Received:

TBD

Decision Date:

TBD

Decision:

TBD

5 2012 -JUL

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Predicate Device:

Synapse 3D Cardiac Tools, FUJIFILM Medical Systems U.S.A., Inc. (K103465) .
QPlaque MR, Medical Imaging Systems, B.V. (K073156) .

Description of the Device

Synapse 3D Cardiac Tools (V3.0) is the updated version of previously-cleared Synapse 3D Cardiac Tools software (cleared by CDRH via K103465 on 01/31/2011).
Synapse 3D Cardiac Tools is used in addition to the Synapse 3D Base Tools (K120361, cleared on April 6, 2012) to analyze the images acquired from CT and MR. Synapse 3D Cardiac Tools is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning of DICOM compliant medical images. This product is not intended for use with or for the primary diagnostic interpretation of mammography images.

Unchanged Applications from the cleared version K103465

(1) Cardiac Function (CT)
Cardiac Function (CT) is an application for cardiac function evaluation which obtains the boundary between left ventricle and cardiac wall from CT left ventriculography images retrieved from multiple time phases and calculates ejection fraction, end-diastolic volume, end-systolic volume, stroke volume, etc.
(2) Cardiac Function (MR)
Cardiac Function (MR) is an application for cardiac function evaluation which obtains the boundary between left ventricle and cardiac wall from non-contrasted MR images retrieved from multiple time phases and calculates ejection fraction, end-diastolic volume, endsystolic volume, output volume per beat, etc.
(3) Coronary Arterv Analysis (CT)
Coronary Artery Analysis (CT) is an application using CT coronary arteriography images to extract the path of the target blood vessels and to perform coronary artery evaluation.
(4) Calcium Scoring
The calcium scoring is an application which uses non-contrasted CT images to display the calcification area in the coronary artery with color separation and calculates the calcification quantitative values using the Agatston score method.
(5) Cardiac fusion
Cardiac fusion is an application to create an image having the mutual characteristics of source images of heart. Source images could be original image of CT, MR or NM and the functional image derived from the original image.

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New Application

(6) Coronary Artery Analysis (MR)
Coronary Artery Analysis (MR) is an application using contrast or non-contrast MR heart images to extract the path of the target blood vessels and to perform coronary artery evaluation.

Note: The detail features available in this application are very similar to those in the Coronary Artery Analysis (CT).

In addition to the common image processing functions (such as window width and window level, zooming, panning, flip, rotation, adding annotations on an image, measurement of lengths, areas, etc.), the following image processing tools are available to support the cardiac analysis of the CT and MR images. These tools belong to and are provided by Synapse 3D Base Tools (K120361) that is used with Synapse 3D Cardiac Tools (V3.0).

SUV evaluation: SUV average, standard deviation, etc. can be measured. .
Extraction and Deletion of 3D objects: Editing of mask areas using the smart cut feature. ●
3D clipping: The display area can be specified for 3D display.
Organ segmentation and removal: Organs and other areas of interest in the image data . can be segmented or removed.
Mask editing: The mask area can be edited by lines drawn in freehand. ●
. CPR: CPR images can be created along a specified center line.
Reformat: Plane images in any direction can be created. .
Creation of video files: Video files with 2D or 3D display can be created. .
. Surface display: A polygon model of an image can be created.

Indication for Use

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Functional cardiac analysis for CT left ventriculography images: which is intended to evaluate the functional characteristics of heart
Functional cardiac analysis for non-contrast MR heart images: which is intended to evaluate the functional characteristics of heart ·

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Coronary artery analysis for CT coronary arteriography images: which is intended for the A qualitative and quantitative analysis of coronary arteries
Coronary artery analysis for MR heart images: which is intended for the qualitative and quantitative analysis of coronary arteries
Calcium scoring for non-contrast CT heart images: which is intended for non-invasive identification and quantification of calcified atherosolerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms
Cardiac Fusion: which is intended to analyze cardiac anatomy and pathology with a fused image of functional data (e.g. NM image, Bulls eye) and anatomical data.

Technological Characteristics

Synapse 3D Cardiac Tools introduces no new safety or efficacy issues other than those already indentified with the predicate devices. The results of the Hazard Analysis combined with the appropriate preventive measures taken indicate that the device is of moderate concern as per the May 11, 2005 issue of the "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices."

Testing

Synapse 3D Cardiac Tools is tested successfully with reference to its Software Requirements Specification, as well as design verification and validation documents and Traceability Matrix document. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the Synapse 3D Cardiac Tools software, which is found to be safe and effective and substantially equivalent to the currently-cleared predicate device.

Conclusion

This 510(k) premarket notification submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health. We conclude the subject device to be as safe and effective as the predicate devices.

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with a double-stranded snake winding around a staff. The seal is in black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

FUJIFILM Medical Systems U.S.A., Inc. C/O JY-SHYAN LIN, Ph.D. Senior Manager, Regulatory, Quality and Clinical Affairs 419 West Avenue Stamford, Connecticut 06902

5 2012 JUL

Re: K120636

Trade/Device Name: Synapse 3D Cardiac Tools Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System (PACS) Regulatory Class: Class II Product Code: LLZ Dated: June 21, 2012 Received: June 22, 2012

Dear Mr. Lin:

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 101 use stated in the encreases, it together than the of the Medical Device Amendments, or to commores that have been reclassified in accordance with the provisions of the Federal Food, Drug, de vices that nave been receasined in assere approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tournal controls provisions of the Act include requirements for annual registration, listing of general controll pro reserving 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 11 your device is elaborited (ove as regulations affecting your device can be found in Title 21, additional controls. Extraing mayor regulation, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination and mean that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a dolor regulations administered by other Federal agencies. You must of any rederal statutes and regenances including, but not limited to: registration and listing (21) Comply with an the Act 3 requirements, articles, " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , "

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device-related active systems (QS) regulation (21 CFR Part 820). This letter requireliens as set forth in the quality of evice as described in your Section 510(k) premarket will anow you to begin mationing your as not a equivalence of your device to a legally marketed nonication. The I Drivinang of sication 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 CFF Pats 801 and 11 you desire specific darree 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

under the MDA regulation (2) "CFFF at 000), portal roblem/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 Tou may other other gettivers, 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

510(k) Number (if known):

Device Name: Synapse 3D Cardiac Tools

Indications for Use:

Synapse 3D Cardiac Tools is medical imaging software used with Synapse 3D Base Tools Ontapor of our of trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Cardiac Tools accepts DICOM incompliant medical images acquired from a variety of imaging devices including, CT, MR, NM, and XA.

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Functional cardiac analysis for CT left ventriculography images: which is intended to evaluate the functional characteristics of heart
Functional cardiac analysis for non-contrast MR heart images: which is intended to evaluate the functional characteristics of heart
Coronary artery analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries
Coronary artery analysis for MR heart images: which is intended for the qualitative and quantitative analysis of coronary arteries
Calcium scoring for non-contrast CT heart images: which is intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms
Cardiac Fusion: which is intended to analyze cardiac anatomy and pathology with a fused image of functional data (e.g. NM image, Bulls eye) and anatomical data.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

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

(Division Sign-Off)

Page 1 of

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K

Synapse 3D Cardiac Tools V3.0 510(k) Submission

22 of 1881

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).