Fujifilm's Tomosynthesis option is intended to acquire tomographic images of human anatomy and to be used with Fujifilm's DR X-ray systems. Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. It is not intended for mammographic applications.

Device Description

Tomosynthesis is an advanced radiographic application that produces individual coronal "slice" images through an anatomical region of interest (ROI). To produce these slices, multiple projection radiographic images are acquired in rapid succession as the X-ray tube sweeps and rotates across the ROI. Once acquired, these projection images are subject to image processing that registers and reconstructs them into individual tomographic slices.

AI/ML Overview

Here's a summary of the acceptance criteria and study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Regulatory Compliance	Conformance to applicable voluntary standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-4, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, IEC 60825-1, UL 60601-1, DICOM.	The proposed device conforms to the listed voluntary standards.
Device Performance	Satisfactory results from bench testing.	Bench testing to evaluate Tomosynthesis performance was completed, and the results were satisfactory.
Software Functionality	Satisfactory results from software verification and validation testing.	Software verification and validation testing demonstrated satisfactory results.
Image Quality	Diagnostic image quality substantially equivalent to legally marketed devices, including the existing linear tomography capability of the AcSelerate system.	Image quality evaluation demonstrated the proposed Tomosynthesis' diagnostic image quality is substantially equivalent to legally marketed devices, including the existing linear tomography capability of the AcSelerate system.
Substantial Equivalence	Similar Indications for Use, functional, and technical requirements as the predicate device (K051967), and similar X-ray system and generator specifications as the previously-cleared FDR AcSelerate System (K093427).	The proposed device has very similar Indications for Use, functional and technical requirements as the predicate device, K051967. Most X-ray system and X-ray generator specifications remain the same as the previously-cleared FDR AcSelerate System in K093427.

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

The document mentions "Various bench testing" and "software verification and validation testing" but does not specify the sample size of cases or tests used in these evaluations. It also does not provide details on the data provenance (e.g., country of origin, retrospective or prospective nature) for the images or data used in the image quality evaluation.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in any of the evaluations. The comparison is made against "legally marketed devices" and the "existing linear tomography capability," implying a comparative assessment rather than an independent expert ground truth establishment for a specific test set.

4. Adjudication method for the test set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating the test results.

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:

No information indicates that a multi-reader multi-case (MRMC) comparative effectiveness study was conducted, nor is there any mention of AI assistance or its effect size on human readers. The Tomosynthesis option itself is a new imaging modality, not an AI-assisted interpretation tool mentioned in this document.

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

The device described is an X-ray system component that produces images, not an algorithm that interprets images. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study as typically applied to AI interpretation algorithms is not directly applicable here. The "image quality evaluation" assesses the quality of the output images themselves, which would then be interpreted by humans.

7. The type of ground truth used:

For the image quality evaluation, the implicit ground truth appears to be established by comparison to the image quality of "legally marketed devices" and the "existing linear tomography capability" of the predicate system. This suggests a comparative evaluation against established diagnostic quality standards rather than an independent gold standard like pathology or long-term outcomes data for each case. The "satisfactory" outcomes for bench testing and software verification likely rely on meeting predefined engineering and performance specifications.

8. The sample size for the training set:

The document is a 510(k) summary for a hardware/software upgrade to an X-ray system, not a machine learning algorithm that requires a training set in the typical sense. Therefore, information about a "training set" is not relevant and not provided.

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

As this is not a machine learning device with a training set, this question is not applicable to the provided document.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Fujifilm Medical Systems, USA. The logo is in black and white, with the word "FUJIFILM" in large, bold letters. Below the company name is the text "Fujifilm Medical Systems, USA" in a smaller font. The logo is simple and modern, and it is likely used on the company's website, marketing materials, and products.

K121499

510(k) Summary

Date: October 29, 2012

Submitter's Information:

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

NOV 2 0 2012

Contact Person:

Name:	Katherine Y. Choi, RAC
Title:	Regulatory Affairs Specialist
Telephone:	(203) 602-3568
Facsimile:	(203) 602-3785

Identification of the Proposed Device:

Proprietary/Trade Name:

Common Name: Device Class: Review Panel:

FUJIFILM Tomosynthesis option for FDR AcSelerate Stationary X-ray System Stationary X-ray System Class II Radiology

Classification Information:

Classification Name	CFR Section	Product Codes
Stationary X-ray System	21 CFR 892.1680	KPR
Solid State X-ray Imager (Flat Panel/DigitalImager)	21 CFR 892.1650	MQB
Tomographic X-ray System	21 CFR 892.1740	IZF

l. INDICATIONS FOR USE

II. DEVICE DESCRIPTION

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Image /page/1/Picture/0 description: The image shows the logo for Fujifilm Medical Systems, USA. The logo is in black and white, with the word "FUJIFILM" in large, bold letters. Below the word "FUJIFILM" is the text "Fujifilm Medical Systems, USA" in a smaller font. The logo is simple and clean, and it is likely used on the company's products and marketing materials.

Tomosynthesis provides visualization of human anatomy by

1. Removing overlying anatomical structures, which could otherwise obscure a structure of interest by superimposition in a 2 dimensional presentation, and

Producing a number of slice images throughout the entire volume of the anatomy.

Tomosynthesis will be available as an option to the legally marketed FDR AcSelerate Stationary X-ray System (K093427) with some modifications. To support Tomosynthesis application, the new Tomosynthesis software and new system component called Pre-Processing Unit (PPU) are required along with the upgraded version of the FDX Console. The new 17x17" Csl (cesium iodide) built-in detector, which replaced the previous a-Se (amorphous selenium) 17x17" FPD, will be used for Tomosynthesis.

lll. SUMMARY OF STUDIES

The proposed device conforms to the following voluntary standards as applicable to the system.

IEC 60601-1	Medical electrical equipment - Part 1: General requirements for safety
IEC 60601-1-2	Medical electrical equipment - Part 1-2: General requirements for safety- Collateral standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-1-3	Medical electrical equipment - Part 1-3: General requirements for safety- Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
IEC 60601-1-4	Medical electrical equipment - Part 1-4: General requirements for safety- Collateral Standard: Programmable Electrical Medical systems
IEC 60601-2-7	Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
IEC 60601-2-28	Medical electrical equipment - Part 2-28: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
IEC 60601-2-32	Medical electrical equipment - Part 2-32: Particular requirements for the safety of associated equipment of X-ray equipment
IEC 60825-1	Safety of laser products - Part 1: Equipment classification and requirements
UL 60601-1	Medical electrical equipment - Part 1: General requirements for safety
DICOM	Digital Imaging and Communications in Medicine (DICOM)

Various bench testing in addition to software verification and validation testing to evaluate the Tomosynthesis performance were completed and the results were satisfactory. Additionally the image quality evaluation demonstrated the proposed Tomosynthesis' diagnostic image quality is substantially equivalent to the legally marketed devices, including the existing linear tomography capability of the AcSelerate system. The supporting documents are enclosed in the submission along with sample images.

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Image /page/2/Picture/0 description: The image shows the logo for Fujifilm Medical Systems, USA. The logo is in black and white, with the word "FUJIFILM" in large, bold letters. Below the word "FUJIFILM" is the text "Fujifilm Medical Systems, USA" in a smaller font. The logo is simple and clean, and it is likely used on the company's products and marketing materials.

IV. SUBSTANTIAL EQUIVALENCE

The proposed device, FUJIFILM Tomosynthesis option for FDR AcSelerate Stationary X-ray System is substantially equivalent to the following legally marketed devices.

Legally Marketed Device	510(k) #
Revolutionary XR/d with Tomosynthesis	K051967
FDR AcSelerate Stationary X-ray System	K093427

The proposed device has the very similar Indications for Use, functional and technical requirements as the predicate device, K051967. In addition, most X-ray system and Xray generator specifications remain the same as the previously-cleared FDR AcSelerate System in K093427.

V. CONCLUSION

We concluded the proposed FUJIFILM Tomosynthesis option for FDR AcSelerate Stationary X-ray System is as safe and effective as the legally marketed devices based upon the studies summarized above.

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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 features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands representing the department's various services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus. The overall design is simple and professional, reflecting the department's role in public health and welfare.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO-66 Silver Spring, MD 20993-002

November 20, 2012

Ms. Katherine Choi Regulatory Affairs Specialist FUJIFILM Medical Systems USA, Inc. 419 West Avenue STAMFORD CT 06902

Re: K121499

Trade/Device Name: FUJIFILM Tomosynthesis option for FDR AcSelerate Stationary X-ray System Regulation Number: 21 CFR 892.1740

Regulation Name: Tomographic x-ray system Regulatory Class: II Product Code: IZF Dated: October 29, 2012 Received: November 1, 2012

Dear Ms. Choi:

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 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

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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.

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 Diagnostics and Radiological Health 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,

Janine M. Morris -S

Janine M. Morris 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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510(k) Number (if known): K121499

Device Name: FUJIFILM Tomosynthesis for FDR AcSelerate Stationary X-ray System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use . (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 Diagnostics and Radiological Health (OIR)

Janine M. Morris -S 2012.11.20 15:28:15 -05'00'

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

K121499 510(k) =

Page 1 of

Regulation Number and Section

§ 892.1740 Tomographic x-ray system.

(a)
Identification. A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.