Synapse 3D Lung and Abdomen 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 Lung and Abdomen 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 Lung and Abdomen Analysis is intended to;

use non-contrasted and contrast enhanced computed tomographic images of the lung, perform boundary detection and volume calculation for pulmonary nodes in the lung based on the location specified by the user and display low absorption areas.
use non-contrasted CT images and calculate subcutaneous fat and visceral fat areas in 2D and both volumes in 3D.

Device Description

Synapse 3D Lung and Abdomen Analysis is an application that can perform volume calculation for pulmonary nodes, display of low absorption areas, and other analysis for Lung contrasted and non-contrasted CT volume date. In addition, the application can calculate the area and volume (3D) of subcutaneous fat and visceral fat using abdomen CT images. The result can be displayed as a graph, and the fat quantity at each slice position can be presented.

Synapse 3D Lung and Abdomen 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 Lung and Abdomen Analysis is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting, and treatment planning and accepts DICOM compliant medical images.

Synapse 3D Lung and Abdomen 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 Lung and Abdomen 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the Synapse 3D Lung and Abdomen Analysis device:

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or numerical reported device performance in a table format. It focuses on the general statement that "All planned verification and validation tests for Synapse 3D Lung and Abdomen Analysis have passed and the design validation has been successfully completed."

However, based on the device's intended use, we can infer the functional performance aspects that would have been tested:

Acceptance Criteria (Inferred)	Reported Device Performance (General)
Accurate boundary detection of pulmonary nodes.	All planned verification and validation tests passed.
Accurate volume calculation for pulmonary nodes.	All planned verification and validation tests passed.
Correct display of low absorption areas in the lung.	All planned verification and validation tests passed.
Accurate calculation of subcutaneous fat area (2D).	All planned verification and validation tests passed.
Accurate calculation of visceral fat area (2D).	All planned verification and validation tests passed.
Accurate calculation of subcutaneous fat volume (3D).	All planned verification and validation tests passed.
Accurate calculation of visceral fat volume (3D).	All planned verification and validation tests passed.
Proper display of fat quantity at each slice position.	All planned verification and validation tests passed.
Compatibility with DICOM-compliant CT images.	Verification and validation tests indicate compatibility.
Integration with Synapse 3D Basic Tools, Synapse Workstation, and Synapse Cardiovascular.	Verification and validation tests confirm integration.
No new safety or efficacy issues compared to predicate devices.	Hazard Analysis combined with preventive measures indicates moderate concern, device is substantially equivalent to predicates.

Study Information:

Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the sample size used for the test set (verification and validation testing).
- Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective.
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 of experts or their qualifications used to establish ground truth for the test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe any adjudication method used for the test set.
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 or any effect size related to human reader improvement with AI assistance. The device is described as "tools to aid them in reading, interpreting, reporting, and treatment planning," implying an assistative role rather than a standalone AI for primary diagnosis that would typically necessitate such a study.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document does not explicitly state that a standalone (algorithm only) performance study was conducted. The description emphasizes the device providing "tools to aid" medical professionals, suggesting it's intended for use with human interpretation rather than as a fully autonomous diagnostic tool.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document does not specify the type of ground truth used for its verification and validation testing. Given the functions (volume calculation, boundary detection, fat measurement), it's highly likely that a form of expert consensus or highly accurate manual measurements by trained professionals on the CT images themselves would have served as ground truth.
The sample size for the training set:
- The document does not provide information on the sample size used for the training set. This is a 510(k) for a medical image processing and analysis software, not typically a machine learning-based device where a training set is a central component of the submission. While such software may use algorithms developed with training data, the 510(k) summary focuses on the validation of the final product.
How the ground truth for the training set was established:
- Since information about a training set or its sample size is not provided, the method for establishing its ground truth is also not described.

Summary

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5. 510(k) Summary

Date Prepared:

MAR 1 6 2011

December 20, 2010

Submitter's Information:

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

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

Device Trade Name:

Synapse 3D Lung and Abdomen 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 Lung and Abdomen Analysis 510(k)

Decision Date:

TBD

Decision:

TBD

Predicate Devices:

Lung Nodule Assessment and Comparison Option (K023785), Philips .
. Aquarius Workstation (K011142), TeraRecon

Description of the Device

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

Indication for Use

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 Lung and Abdomen Analysis is intended to;

use non-contrasted and contrast enhanced computed tomographic images of the lung, .

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perform boundary detection and volume calculation for pulmonary nodes in the lung based on the location specified by the user and display low absorption areas.

. use non-contrasted CT images and calculate subcutaneous fat and visceral fat areas in 2D and both volumes in 3D.

Technological Characteristics

Synapse 3D Lung and Abdomen Analysis 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 Lung and Abdomen Analysis is tested with reference to its Software Requirements Specification, as documented in Section 16.2 as well as design verification and validation documents and Traceability Matrix document included in this 510(k) filing. Functional testing is a part of the Product Development process, and also included in Section 16 of this filing.

The Synapse 3D Lung and Abdomen Analysis software has undergone Verification and Validation Testing, as described in Section 18. Results: All planned verification and validation tests for Synapse 3D Lung and Abdomen Analysis have passed and the design validation has been successfully completed.

Documentation provided in Section 18 demonstrates that our proposed Synapse 3D Lung and Abdomen Analysis software device is 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/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an 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

Ms. Kimberly A. Sharp Quality Assurance/Regulatory Affairs Associate FUJIFILM Medical Systems, USA Inc. 419 West Avenue STAMFORD CT 06902

MAR 1 6 2011

Re: K103720

Trade/Device Name: Synapse 3D Lung and Abdomen Analysis Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 20, 2010 Received: January 6, 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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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 51010). THM sket notification. The FDA finding of substantial equivalence of your device to a legally manaketed predicate device results in a classification for your device and thus, permits your dry man 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 (01) 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): 七山37202

Device Name: Synapse 3D Lung and Abdomen Analysis

Indications for Use:

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 Lung and Abdomen Analysis is intended to;

use non-contrasted and contrast enhanced computed tomographic images of the ● lung, perform boundary detection and volume calculation for pulmonary nodes in the lung based on the location specified by the user and display low absorption areas.
use non-contrasted CT images and calculate subcutaneous fat and visceral fat . areas in 2D and both volumes in 3D.

Prescription Use X Prescription Use______________________________________________________________________________________________________________________________________________________________

ND/OR Over-The
(21 CFR

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. Posth

510K K163220

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).