Synapse 3D Optional 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 Optional Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including CT, MR. 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 Optional Tools provides:

· Imaging tools for CT images including virtual endoscopic viewing.

· Imaging tools for MR images including delayed enhancement image viewing and diffusion-weighted MRI data analysis.

Device Description

Synapse 3D Optional Tools is an optional software module that works with Synapse 3D Base Tools (cleared by via K120361 on 04/06/2012). Synapse 3D Base Tools is connected through DICOM standard to medical devices such as CT, MR, CR, US, NM, PT, XA, etc. and to a PACS system storing data generated by these medical devices, and retrieves image data via network communication based on the DICOM standard. The retrieved image data are stored on the local disk managed by Synapse 3D Base Tools, and the associated information of the image data is registered in the database and used for display, image processing, analysis, etc.

Synapse 3D Optional Tools provides imaging tools for CT and MR images such as virtual endoscopic simulator (CT) (referred collectively as "Endoscopic Simulator"), diffusion-weighted MRI data analysis (MR) (referred collectively as "IVIM"), and delayed enhancement image viewing (MR) (referred collectively as "Delayed Enhancement"). The software can display the images on a display monitor, or printed them on a hardcopy using a DICOM printer or a Windows printer.

Synapse 3D Optional Tools runs on Windows standalone and server/client configuration installed on a commercial general-purpose Windows-compatible computer. It offers software tools which can be used by trained professionals, such as radiologists, clinicians or general practitioners to interpret medical images obtained from various medical devices to create reports or develop treatment plans.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

The provided document (K181773 for Synapse 3D Optional Tools) does not contain a detailed table of acceptance criteria or comprehensive study results for specific performance metrics in the way one might expect for a new AI/CAD device. Instead, it leverages its classification as a "Picture Archiving And Communications System" (PACS) and positions itself as substantially equivalent to predicate devices. This typically means that formal performance studies with detailed acceptance criteria and reported metrics demonstrating specific diagnostic accuracy are not required in the same way as a de novo device or a device making a new diagnostic claim.

The focus is on demonstrating that the features and technical characteristics are similar to existing cleared devices, and that the software development process and risk management ensure safety and effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

As mentioned above, the document does not present a table of quantitative acceptance criteria for performance metrics (e.g., sensitivity, specificity, AUC) and corresponding reported performance values for the Synapse 3D Optional Tools. The "acceptance criteria" are implied to be fulfilled by following software development processes, risk management, and successful functional and system-level testing, which are designed to ensure the device operates as intended and is substantially equivalent to predicate devices.

The "reported device performance" is described qualitatively as:
"Test results showed that all tests passed successfully according to the design specifications. All of the different components of the Synapse 3D Optional Tools software have been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate according to its intended use and in a manner substantially equivalent to the predicate devices."

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

The document states:
"benchmark performance testing was conducted using actual clinical images to help demonstrate that the semi-automatic segmentation, detection, and registration functions implemented in Synapse 3D Optional Tools achieved the expected accuracy performance."

However, it does not specify the sample size of the clinical images used for this benchmark performance testing. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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)

The document does not provide information on how ground truth was established for the "actual clinical images" used in benchmark performance testing, nor does it mention the number or qualifications of experts involved in this process.

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

The document does not specify any adjudication method for establishing ground truth or evaluating the test set.

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

The document does not mention a multi-reader, multi-case (MRMC) comparative effectiveness study. It explicitly states: "The subject of this 510(k) notification, Synapse 3D Optional Tools did not require clinical studies to support safety and effectiveness of the software." This reinforces the idea that the submission relies on substantial equivalence and non-clinical testing rather than new clinical effectiveness studies involving human readers.

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

The document notes that "benchmark performance testing was conducted using actual clinical images to help demonstrate that the semi-automatic segmentation, detection, and registration functions implemented in Synapse 3D Optional Tools achieved the expected accuracy performance." This implies some form of standalone evaluation of these specific functions' accuracy. However, "standalone performance" in the context of diagnostic accuracy (e.g., sensitivity/specificity of an AI model) is not explicitly detailed or quantified. The device is described as providing "tools to aid them [trained medical professionals] in reading, interpreting, reporting, and treatment planning," indicating it's an assistive tool, not a standalone diagnostic AI.

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

The document does not explicitly state the type of ground truth used for the "actual clinical images" in the benchmark testing. Given the general nature of the tools (segmentation, detection, registration), the ground truth for "accuracy performance" would likely involve expert-defined annotations or measurements on the images themselves, rather than pathology or outcomes data. However, this is an inference, not a stated fact in the document.

8. The sample size for the training set

The document does not provide information regarding a training set. This is consistent with a 510(k) for software tools that are substantially equivalent to existing PACS systems, rather than a de novo AI/ML algorithm that requires extensive training data. While it mentions "semi-automatic segmentation, detection, and registration functions," which often involve learned components, the submission focuses on the functionality of these tools as part of a PACS system rather than reporting on the underlying AI model's development details.

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

Since no training set information is provided, there is no information on how ground truth for a training set was established.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

September 25, 2018

FUJIFILM Corporation % Jeffrey Wan Specialist. Regulatory Affairs FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue STAMFORD, CT 06902

Re: K181773

Trade/Device Name: Synapse 3D Optional Tools Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: September 6, 2018 Received: September 7, 2018

Dear Jeffrey Wan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Hsl 2. Nils

for Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K181773

Device Name Synapse 3D Optional Tools

Indications for Use (Describe)

· Imaging tools for CT images including virtual endoscopic viewing.

· Imaging tools for MR images including delayed enhancement image viewing and diffusion-weighted MRI data analysis.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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FUJIFILM Medical Systems U.S.A., Inc.,Synapse 3D Optional Tools (V5.2) 510(k)
510(k) Summary
Date Prepared:	July 1, 2018
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:	Jeffrey Wan
Device Trade Name:	Synapse 3D Optional Tools
Device Common Names:	Picture Archiving and Communications System (PACS)
Device Clasification Name:	System, Image Processing, Radiological
Product Code:	LLZ
Regulation Number:	21 CFR 892.2050
Device Class:	Class II
Panel:	Radiology
Primary Predicate Devices:	Synapse 3D Base Tools (K120361), FUJIFILM MedicalSystems U.S.A., Inc.
Reference Predicate Devices:	REX™ (K021099), PointDx, Inc.Olea Sphere V3.0 (K152602), Olea Medical

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FUJIFILM Medical Systems U.S.A., Inc., Synapse 3D Optional Tools (V5.2) 510(k)

1. Description of the Device

Indications for Use 2.

· Imaging tools for CT images including virtual endoscopic viewing.
· Imaging tools for MR images including delayed enhancement image viewing and diffusionweighted MRI data analysis.

Substantial Equivalence Comparison 3.

Synapse 3D Optional Tools has the same intended use, similar labeling, and clinical application tools as those of the cleared primary predicate device Synapse 3D Base Tools (K120361).and reference predicate devices REX, VERSION 1.0 (K021099) and Olea Sphere V3.0 (K152602). The device features and technical characteristics comparison with predicate and reference devices is shown as Table 1.

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Table 1 Device Features and Technical Characteristics Comparison Matrix

Device Parameters	Synapse 3D OptionalTools(This submission)	Synapse 3D Base Tools(K120361)(Primary predicate device)	REX™(K021099)(Reference device)	Olea Sphere V3.0(K152602)(Reference device)
2D Viewing	Yes	Yes	Yes	Yes
Image Storing (DICOMSCP)	Yes	Yes	N/A	Yes
Image Communication(DICOM SCU)	Yes	Yes	Yes	Yes
DICOM Interface(SCP/SCU)	Yes	Yes	Yes	Yes
Printing (DICOM SCU)	Yes	Yes	N/A	N/A
Measurements (2D and 3D)	Yes	Yes	Yes	Yes
Annotations - Standardizedand Free Text	Yes	Yes	Yes	Yes
Reporting	Yes	Yes	Yes	Yes
Cine	Yes	Yes	N/A	N/A
Volume Rendering and 3DViewing	Yes	Yes	Yes	Yes
MPRorthogonal / oblique /curved Multi-PlanarReconstructions (MPR),Sector and rectangularshape MPR imageviewingMultiple MPR images	Yes	Yes	Yes	Yes
along an object (Slicer)
Maximum, Average,Minimum IntensityProjection	Yes	Yes	N/A	N/A
4D viewing	Yes	Yes	N/A	N/A
Image fusion	Yes	Yes	N/A	N/A
Surface rendering	Yes	Yes	N/A	N/A
Image subtraction (3D)	Yes	Yes	N/A	N/A
Time-density distribution	Yes	Yes	N/A	N/A
General image datamanagement andadministration tools	Yes	Yes	Yes	Yes
Real time display ofendoscopic view	Yes	N/A	Yes	N/A
Internal and externalviewing of any hollowstructure	Yes	N/A	Yes	N/A
Visualizing the diffusionproperties (IVIM map) fromthe analysis ofdiffusion-weighted MRI data	Yes	N/A	N/A	Yes
Display of delayedenhancement MR images	Yes	N/A	N/A	N/A
Hardware Platform	Windows PC	Windows PC	Windows PC	Windows PC

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FUJIFILM Medical Systems U.S.A., Inc., Synapse 3D Optional Tools (V5.2) 510(k)

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FUJIFILM Medical Systems U.S.A., Inc., Synapse 3D Optional Tools (V5.2) 510(k)

4. Safety Information

Synapse 3D Optional Tools introduces no new safety or efficacy issues other than those already indentified with the predicate devices. The Risk Management and 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." The Synapse 3D Optional Tools labeling contains instructions for use and necessary cautions, warnings and notes to provide the safe and effective use of the device.

5. Testing and Performance Information

Nonclinical testing result:

· Software development plan
· Software hazard analysis and risk management
· Software requirements analysis/specification
· Software architectural design
· Software detailed design specification
· Software unit module) Implementation and verification
· Software integration and system testing

Clinical tests:

The subject of this 510(k) notification, Synapse 3D Optional Tools did not require clinical studies to support safety and effectiveness of the software.

Verification and Validation:

The purpose of Software Development Process for Synapse 3D Optional Tools is to carry out the activities relating to the establishment of the software development plan (or definitely conducting software requirement analysis, architectural design, the detailed design, unit implementation and verification, software integration testing, software system test, software release, software maintenance. Testing involved system level functionality test, component testing, verification testing, integration testing, installation/upgrade testing, labeling testing, as well as the testing for risk mitigations associated with the risk management process. In addition, benchmark performance testing was conducted using actual clinical images to help

05- 6 510(K) Summary

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FUJIFILM Medical Systems U.S.A., Inc.,

Synapse 3D Optional Tools (V5.2) 510(k)

demonstrate that the semi-automatic segmentation, detection, and registration functions implemented in Synapse 3D Optional Tools achieved the expected accuracy performance. Pass/Fail criteria were based on the requirements and intended use of the product. Test results showed that all tests passed successfully according to the design specifications. All of the different components of the Synapse 3D Optional Tools software have been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate according to its intended use and in a manner substantially equivalent to the predicate devices.

Cybersecurity:

The confidentiality, integrity and availability are maintained by Synapse 3D Optional Tools in accordance with Section 6 of the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Guidance for Industry and Food and Drug Administration Staff (October 2, 2014).

Synapse 3D Optional Tools is connected through DICOM standard to medical devices such as CT, MR, CR, US, NM. PT, XA, etc. and to a PACS system storing data generated by these medical devices, and it retrieves image data via network communication based on the DICOM standard. Therefore Synapse 3D Optional Tools assure an adequate degree of protection for cybersecurity.

Performance standards:

· Digital Imaging and Communications in Medicine (DICOM) Set (PS 3.1 3.20) (2016).
AAMI / ANSI / IEC 62304:2006, Medical Device Software Software Life CycleProcesses.
· ISO 14971 Second Edition 2007-03-01. Medical Devices Application of Risk Management to Medical Devices.

6. Conclusion

Performance tests were conducted to test the functionality of the subject device, Synapse 3D Optional Tools. Results of all conducted testing were acceptable in supporting the claim of substantial equivalence.

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).

Indications for Use

K181773

Indications for Use (Describe)

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1. Description of the Device

Indications for Use 2.

Substantial Equivalence Comparison 3.

Table 1 Device Features and Technical Characteristics Comparison Matrix

FUJIFILM Medical Systems U.S.A., Inc., Synapse 3D Optional Tools (V5.2) 510(k)

4. Safety Information

5. Testing and Performance Information

Nonclinical testing result:

Clinical tests:

Verification and Validation:

Cybersecurity:

Performance standards:

6. Conclusion

§ 892.2050 Medical image management and processing system.

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