Synapse 3D Liver Analysis is medical imaging software used with Synapse 3D Basic Tools that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Liver Analysis accepts DICOM compliant medical images acquired from CT.

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

Addition to Synapse 3D Basic Tools, Synapse 3D Liver Analysis uses contrast enhanced computed tomographic images of the body and provides custom workflows and UI, and reporting functions for liver analysis including, liver segmentation, tumor segmentation, segmentation of intrahepatic vessels as well as the approximation of vascular territories.

Device Description

Synapse 3D Liver Analysis is an application which uses the intravenous contrasted CT study of a liver to segment the liver and various blood vessels and to perform 3D display of the results. Using the information of segmented liver, hepatic vessels, tumors, and the morphological structure of vessel system and blood supply volume of each vessel, the user can analyze the liver, vessels and tumors and plan the treatment.

Synapse 3D Liver Analysis is used in addition to the previously-cleared features available from Synapse 3D Basic Tools (K101662) to analyze the images acquired from CT. Synapse 3D Liver Analysis is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, and treatment planning and accepts DICOM compliant medical images.

Synapse 3D Liver Analysis with Synapse 3D Basic Tools can be integrated with our cleared Fujifilm's Synapse Workstation, version 3.2.1 and above, and can be used as a part of a Synapse system. Synapse 3D Liver Analysis also can be integrated with Fujifilm's Synapse Cardiovascular for cardiology purposes.

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

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study report to prove the device meets these criteria. The document is a 510(k) summary and FDA decision letter for the Synapse 3D Liver Analysis software. It primarily focuses on the regulatory submission, device description, indications for use, and substantial equivalence to a predicate device, rather than a detailed performance study.

However, based on the information available and the general type of device (medical image processing software), we can infer certain aspects and identify what is missing.

Here's an attempt to answer the questions, highlighting what is present and what is not:

Acceptance Criteria and Study Details for Synapse 3D Liver Analysis

1. A table of acceptance criteria and the reported device performance

The provided text does not include a table of acceptance criteria or reported device performance metrics. For a device like Synapse 3D Liver Analysis, which segments structures and provides analysis tools, typical acceptance criteria would involve:

Accuracy of segmentation: e.g., Dice Similarity Coefficient (DSC), volumetric overlap, surface distance metrics for liver, vessels, and tumors.
Precision/Reproducibility: Consistency of results across different users or repeated analyses.
Performance/Speed: Time taken for segmentation and analysis.
Usability: User satisfaction and efficiency with the interface.

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

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective).

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

The document does not provide information on the number or qualifications of experts used to establish ground truth. For a device performing segmentation, ground truth would typically be established by radiologists, surgeons, or other specialists manually segmenting structures on images.

4. Adjudication method for the test set

The document does not mention any adjudication method (e.g., 2+1, 3+1) for a 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 indicate that a MRMC comparative effectiveness study was done. The device is described as providing "tools to aid them [medical professionals] in reading, interpreting, and treatment planning," suggesting an assistive role. However, no study demonstrating an improvement in human reader performance with the aid of the software is reported.

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

The document does not explicitly describe a standalone performance study for the algorithm. While it performs liver and vessel segmentation automatically (as implied by "segment the liver and various blood vessels"), no specific metrics for this standalone performance are provided.

7. The type of ground truth used

The document does not explicitly state the type of ground truth used. For segmentation tasks in medical imaging, ground truth is most commonly established through expert consensus (manual delineation by medical professionals, sometimes with pathology correlation if available).

8. The sample size for the training set

The document does not mention the sample size used for the training set. Given the date (2011), the use of deep learning (which requires large training sets) was not as prevalent as it is today, but some form of training data would have been necessary for segmentation algorithms.

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

The document does not describe how the ground truth for the training set was established. Similar to the test set, it would likely involve manual annotation by experts.

Summary

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APR - 7 2011

5. 510(k) Summary

Date Prepared:

January 20, 2011

Submitter's Information:

FUJIFILM Medical Systems USA, Inc. 419 West Avenue Stamford, Connecticut 06902

Telephone: (203) 602-3665 Fax: (203) 251-7863 Kimerly A. Sharp Contact:

Device Trade Name:

Synapse 3D Liver Analysis

Device Common Name:

Medical Image Processing and Analysis Software

Regulation Number:

21 CFR 892.2050

Device Classification:

Class II

Device Classification Name

Picture Archiving Communication System (PACS)

Panel:

Radiology

Product Code:

90-LLZ

Date Received:

TBD

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FUJIFILM Medical Systems U.S.A. Inc., Synapse 3D Liver Analysis 510(k)

Decision Date:

TBD

Decision:

TBD

Predicate Devices:

IQQA-Liver Software (K061696), EDDA Technology .

Description of the Device

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

Indication for Use

Synapse 3D Liver Analysis is medical imaging software used with Synapse 3D Basic Tools that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, and treatment planning. Synapse 3D Liver Analysis accepts DICOM compliant medical images acquired from CT.

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

Addition to Synapse 3D Basic Tools, Synapse 3D Liver Analysis uses contrast enhanced computed tomographic images of the body and provides custom workflows and UI, and reporting

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is depicted in a simple, abstract style, with thick, curved lines forming its body and wings. The text is in a sans-serif font and is evenly spaced around the circle.

Public Health Service

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

Ms. Kimerly A. Sharp Quality Assurance/Regulatory Affairs Associate FUJIFILM Medical System U.S.A., Inc. 419 West Avenue STAMFORD CT 06902

APR - 7 2011

Re: K110186

Trade/Device Name: Synapse 3D Liver Analysis Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 20, 2011 Received: January 21, 2011

Dear Ms. Sharp:

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 comply with 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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Page 2

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.

Mary Pastel

Mary S. Pastel, Sc.D. 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 Liver Analysis

Indications for Use:

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

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH. Office of In Vitro Diagnostic Device (OIVD)

Mary S. Patel

(Division Sign-Off)

Office of In Vitro

510K K110186

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).