ASPIRE Bellus is intended to receive digital mammography images and to display these images on monitors for radiologists' review for diagnostic and screening purposes. To assist radiologists, ASPIRE Bellus provides functions such as image review, measurement, post-processing, film printing, displaying mammography CAD results, and image manipulation.

ASPIRE Bellus does not accept lossy compressed mammographic images, which should not be used for primary diagnostic interpretation. Display monitors connected to ASPIRE Bellus for diagnostic interpretation of mammographic images must be cleared for use in digital mammography. All images sent to or imported into the ASPIRE Bellus must conform to regulatory requirements. Image quality must conform to applicable quality guidelines.

Device Description

FUJIFILM's Mammography Viewer SMV658 (V3.0) system receives mammography images directly from FUJIFILM's digital mammography acquisition systems using DICOM protocol and PACS via network. These images are displayed on mammography diagnostic monitors for doctors' review. The SMV658 system works as mammography workstation depending on its configuration (monitors) and license information (software key). The system provides visualization and image enhancement tools (such as image review, measurement, postprocessing, film printing, displaying mammography CAD results, and image manipulation) to assist the radiologists' review of mammography images for diagnostic and screening purposes.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the FUJIFILM Medical Systems U.S.A., Inc. SMV658 V3.0 (ASPIRE Bellus / Mammography Viewer SMV658) 510(k) submission.

Critical Note: The provided 510(k) summary is for a mammography viewer software (PACS), not an AI or CAD device. Therefore, the typical performance metrics (sensitivity, specificity, AUC) and study designs (MRMC, standalone) associated with AI diagnostic aids are not present because the device's function is image display and manipulation, not diagnostic interpretation. The "acceptance criteria" discussed are primarily related to software functionality and safety, not diagnostic accuracy.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance	Comments from the Document
Software Functionality	Passed all tests	"Mammography Viewer SMV658 is tested successfully with reference to its Software Requirements Specification, as well as design verification and validation documents and Traceability Matrix document." "Test results showed that all tests successfully passed."
Segmentation Accuracy	Passed all tests	"Testing involved system level functionality test, segmentation accuracy test, measurement accuracy test, interfacing test, usability test, serviceability test, labeling test, as well as the test for risk mitigation method analyzed and implemented in the risk management process."
Measurement Accuracy	Passed all tests	(See above for Segmentation Accuracy)
Interfacing	Passed all tests	(See above for Segmentation Accuracy)
Usability	Passed all tests	(See above for Segmentation Accuracy)
Serviceability	Passed all tests	(See above for Segmentation Accuracy)
Labeling	Passed all tests	(See above for Segmentation Accuracy)
Risk Mitigation	Passed all tests	(See above for Segmentation Accuracy)
Bench Performance (with clinical images)	Achieved expected accuracy performance	"In addition, we conducted the bench performance testing using actual clinical images to help demonstrate that the proposed device achieved the expected accuracy performance."
Safety and Effectiveness	Deemed safe and effective and substantially equivalent to predicate	"Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the Mammography Viewer SMV658 software, which is found to be safe and effective and substantially equivalent to the currently cleared predicate devices."

Study Details (Based on the provided text)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document mentions "bench performance testing using actual clinical images." However, it does not specify the sample size of these clinical images.
- The provenance (country of origin, retrospective/prospective) of the clinical images used for bench performance testing is not mentioned in the provided text.
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 describe an expert-based ground truth establishment process for a diagnostic performance study. The "testing" mentioned is primarily focused on software functionality and its ability to display images and perform measurements as intended. For "bench performance testing using actual clinical images," it's implied that the accuracy of the software's display and measurement capabilities was assessed, but not against a "ground truth" of disease presence/absence established by experts for diagnostic purposes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / not mentioned. Since there is no expert-based ground truth establishment for diagnostic performance, adjudication methods for disagreements among experts are not relevant to the described testing.
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:
- No, an MRMC comparative effectiveness study was not done. The device is a mammography viewer, not an AI or CAD system intended to provide diagnostic interpretations or assist human readers in lesion detection/diagnosis. Therefore, the concept of human reader improvement with or without AI assistance is not relevant to this device's intended use and testing.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone diagnostic performance study was not done. This device is a viewer that supports radiologists; it is not an algorithm designed to make diagnostic interpretations or detections independently. Its "performance" relates to its functionality, display accuracy, and measurement capabilities, not standalone diagnostic accuracy. The bench testing with clinical images likely validated its ability to correctly display and measure features, not to diagnose.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "bench performance testing using actual clinical images," the document does not explicitly state the type of "ground truth" used. However, given the device's function (viewer with measurement tools), the "ground truth" for these tests would likely involve:
  - Reference measurements: For measurement accuracy, a known, precise measurement (e.g., from a calibrated tool or pre-adjudicated measurement on the image) would serve as ground truth to compare against the device's measurement function.
  - Image integrity/display fidelity: For display-related performance, the ground truth would be the original image data and its accurate representation on the monitor.
- It is not using pathology, expert consensus on disease, or outcomes data, as those are typical for diagnostic AI devices, which this is not.
The sample size for the training set:
- Not applicable / not mentioned. This device is an image viewer with image processing and manipulation tools. It does not appear to be an AI or machine learning model that requires a "training set" in the conventional sense for diagnostic prediction. Its development likely involved standard software engineering practices and testing against specifications.
How the ground truth for the training set was established:
- Not applicable / not mentioned. As there's no indication of a training set for an AI/ML model, the establishment of ground truth for such a set is not discussed.

Summary of Device and Context:

It's crucial to understand that the FUJIFILM Medical Systems U.S.A., Inc. SMV658 V3.0 (ASPIRE Bellus / Mammography Viewer SMV658) is a PACS (Picture Archiving and Communications System) or a specialized workstation for viewing digital mammography images. Its primary functions are receiving, displaying, enhancing, and manipulating images, as well as displaying CAD results (generated by other cleared CAD systems, not the viewer itself).

Therefore, the "acceptance criteria" and "study" described in this 510(k) are focused on:

Software verification and validation: Ensuring the software functions as designed, is reliable, and meets its specifications.
Safety: Hazard analysis and mitigation.
Substantial equivalence: Demonstrating that it performs similarly to other legally marketed mammography viewers without raising new safety or effectiveness concerns.

It is not a diagnostic AI device, and thus, its regulatory submission does not include the typical performance metrics or study designs (e.g., MRMC, standalone performance, sensitivity/specificity) associated with AI-based diagnostic aids.

Summary

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FUJIFILM Medical Systems U.S.A., Inc. SMV658 V3.0 510(k)

5. 510(k) Summary

Date Prepared:

September 10, 2013

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

OCT 2 5 2013

Device Trade Name:

ASPIRE Bellus / Mammography Viewer SMV658

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)

Pane I:

Radiology

Product Code :

LLZ

Date Received:

TBD

Decision Date:

TBD

Decision:

TBD

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FUJIFILM Medical Systems U.S.A., Inc. SMV658 V3.0 510(K)

Predicate Device:

. MammoWorkstation (K081630), Image Diagnostic International GmbH

Description of the Device

Indication for Use

ASPIRE Bellus is intended to receive digital mammography images and to display these images on monitors for radiologists' review for diagnostic and screening purposes.

· To assist radiologists, ASPIRE Bellus provides functions such as image review, measurement, post-processing, film printing, displaying mammography CAD results, and image manipulation.

Technological Characteristics

The proposed Mammography Viewer SMV658 and the predicate device, MammoWorkstation (K081630), are medical application software running on Windows operating system installed on commercial general-purpose Windows-compatible computers. These devices are connected to mammography systems with DICOM standard and retrieve image data via network communications. These devices provide image visualization, enhancement, and manipulation tools for mammography images with various user interfaces and measurement tools for analysis of rendered images. Both the Mammography Viewer SMV658 and the predicate devices support the workflows, UI, and reporting functions for supporting the radiologists' review of mammography images for screening and diagnosis purposes.

Mammography Viewer SMV658 introduces no new safety or efficacy issues other than those already indentified with the predicate device. 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."

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FUJIFILM Medical Systems U.S.A., Inc. SMV658 V3.0 510(k)

Testing

Mammography Viewer SMV658 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 Mammography Viewer SMV658 software, which is found to be safe and effective and substantially equivalent to the currently cleared predicate devices.

Testing involved system level functionality test, segmentation accuracy test, measurement accuracy test, interfacing test, usability test, serviceability test, labeling test, as well as the test for risk mitigation method analyzed and implemented in the risk management process. In addition, we conducted the bench performance testing using actual clinical images to help demonstrate that the proposed device 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 successfully passed.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol with three lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the bird symbol.

Public Health Service

Foud and Drug Administration 10903 New Hampshire Avenue Document Control Center - WObo6-Gods Silver Spring, MD 20993-0002

October 25. 2013

FUJIFILM Medical System U.S.A., Inc. % Jyh-Shyan Lin, Ph.D. Senior Manager, Regulatory, Quality and Clinical Affairs 419 West Avenue STAMFORD CT 06902

Re: K132188

Trade/Device Name: Mammography viewer SMV658/ASPIRE Bellus Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ. Dated: October 2, 2013 Received: October 4, 2013

Dear Dr. 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 commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or 10 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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRFI 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2 - Dr. Lin

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2) 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/McdicalDevices/Safey/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

ரொ

Janine M. Morris 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): K132188

Device Name: ASPIRE Bellus/ Mammography Viewer SMV658

Indications for Use:

Prescription Use メ (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 IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) == K132188

Page 1 of _I

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).