The Wired/Wireless FDR D-EVO flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The FDR D-EVO (DR-ID 600) is not intended for mammography, fluoroscopy, tomography and angiography applications.

Device Description

The Wired/Wireless FDR D-EVO (DR-ID600/DR-ID601.SE) flat panel detector (FPD) system consists of the Fujifilm D-EVO detector, Fujifilm D-EVO system control cabinet, and power supply unit. Images captured with the flat panel digital detector can be communicated to the operator console via tethered connection. Data captured via operator console is sent electronically to the Fujifilm FDX Console to be displayed on the monitor.

Wired/Wireless FDR D-EVO flat panel detector is an indirect-conversion amorphous silicon (a-Si) portable flat panel detector utilizing GOS (Gadolinium OxySulfide) as a scintillator. Wired/Wireless FDR D-EVO detector has Fuji's unique Irradiation Side Sampling system (hereinafter "ISS system").

The X-ray Detection Feature is a minor change to our cleared Wired/Wireless FDR D-EVO FPD detector system which eliminates the need for an electrical interface between the D-EVO system's DR-ID 600 MP and the x-ray exposure system. This is accomplished by incorporating X-ray sensors into the exposure surface of the proposed Wired/Wireless FDR D-EVO Flat Panel Detector.

AI/ML Overview

The provided document describes a Special 510(k) Premarket Notification for the Wired/Wireless FDR D-EVO with X-ray Detection Feature. Here's an analysis of the acceptance criteria and study findings based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in a structured table format with specific metrics (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio, etc.). Instead, the performance evaluation is based on a qualitative assessment of diagnostic equivalence.

Evaluation Metric	Acceptance Criteria (Implied)	Reported Device Performance
Image Quality	Images from the proposed device (with X-ray Detection Feature) must be diagnostically equal to images from the predicate device (without the feature).	"all participants found the D-EVO images with the X-ray Detection Feature were diagnostically equal to the predicate device images."
Artifact Presence	X-ray sensors incorporated into the exposure surface should not be visible in the image.	"No participant was able to visualize the X-ray sensors."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document states "Identically exposed and processed anthropomorphic phantom image pairs (proposed device vs. predicate device)". The exact number of image pairs or phantom cases is not specified.
Data Provenance: The study was conducted using "anthropomorphic phantom image pairs." The country of origin of the data is not specified, but it was an internal study by Fujifilm. The study type was retrospective in the sense that images were captured and then evaluated, but it wasn't a clinical retrospective study of patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: The images were judged by "3 Fujifilm Imaging Specialists, as well as a board-certified radiologist." This makes a total of 4 experts.
Qualifications: "board-certified radiologist" and "3 Fujifilm Imaging Specialists." The specific years of experience for the radiologist or the imaging specialists are not provided.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated. The document only mentions that the images were "judged by" the experts. It's unclear if a consensus was formed, or if individual opinions were aggregated, or if the radiologist's opinion was given more weight. However, the reported outcome "all participants found the D-EVO images...were diagnostically equal" suggests a unanimous agreement or a consensus process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus human readers without AI assistance was not done. This study focused on comparing the image quality of a modified device (with X-ray detection feature) against its predicate device, not on AI assistance for human readers.

6. If a Standalone Study Was Done

No, a standalone study (algorithm only without human-in-the-loop performance) was not done. The study involved human experts evaluating images produced by the device. The device itself (the flat panel detector) is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the test set was indirectly inferred through expert consensus/opinion on "diagnostic equivalence" and visibility of artifacts in anthropomorphic phantom images. Since it's a comparison of two devices capturing phantom images, there isn't a "pathology" or "outcomes data" type of ground truth in the traditional sense. The baseline for comparison was the predicate device's image quality.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as the device is a hardware component (a flat panel detector) and not an AI/machine learning algorithm that requires training data.

9. How the Ground Truth for the Training Set Was Established

As point 8 indicates, there was no training set for this device as it is not an AI/machine learning product.

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 main logo is the text "Fujifilm Medical Systems, USA" in a smaller font. The logo appears to be a standard corporate logo.

SEP 3 0 2011

K111865

Special 510(k) Premarket Notification Summary for Wired/Wireless FDR D-EVO with X-ray Detection Feature

Date: June 29, 2011

Contact Person:

Name:	Debbie Peacock
Title:	Regulatory Affairs Manager
Telephone:	(203) 602-3774
Facsimile:	(203) 363-3813

ldentification of Device:

Proprietary/Trade Name:	Wired/Wireless FDR D-EVO with X-ray DetectionFeature
Classification Name:	Solid State X-ray Imager (Flat Panel/Digital Imager)
Classification:	Panel: Radiology
CFR Section:	21 CFR 892.1650
Product Codes:	90 MQB
Common Name:	Flat Panel Digital Detector

l, INDICATIONS FOR USE

The Wired/Wireless FDR D-EVO flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film /screen or CR systems may be used. The FDR D-EVO (DR-ID600) is not intended for mammorraphy, fluoroscopy, tomography and angiography applications.

II. DEVICE DESCRIPTION

The Wired/Wireless FDR D-EVO (DR-ID600/DR-ID601.SE).flat.panel.detector (FPD) ص ان الاست جي المورد الموري الموري الموري الموري الموري الاست Fujifilm D-EVO detector, Fujifilm D-EVO system control cabinet, and power sugply unit. Images captured with the flat panel digital detector can be communicated to the operator console via tethered connection. Data captured via operator console is sent electronically to the Fujifilm FDX Console to be displayed on the monitor.

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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.

There is no difference in preparation between both the predicate and proposed device. In both cases, the FPDs are informed that an x-ray exposure is imminent by selecting an anatomical menu at the acquisition workstation. Once the anatomical menu is selected, the detectors become "ready" for the exposure. Ready indicators illuminate on both the detector and the acquisition workstation signaling to the technologist that an exposure can be made.

SUMMARY OF STUDIES

Wired/Wireless FDR D-EVO with X-ray Detection Feature has successfully completed internal and international IEC testing requirements, as well as Verification and Veliced in Studies, and the following anthropomorphic phantom image evaluation.

Identically exposed and processed anthropomorphic phantom image pairs (proposed device vs. predicate device) were judged by 3 Fujifilm Imaging Specialists, as well as a board-certified radiologist (See Section 18, Performance Testing). No participant was able to visualize the X-ray sensors, and all participants found the D-EVO images with the X-ray Detection Feature were diagnostically equal to the predicate device images.

III. SUBSTANTIAL EQUIVALENCE

The WiredWireless FDR D-EVO with X-ray Detector Feature is a modification to Fuji's WiredWireless FDR D-EVO Flat Panel Detector System, K103596, cleared by CDRH on 03/29/11. This feature is the only difference between the proposed and predicate device.

IV. CONCLUSION

The Wired/Wireless FDR D-EVO with X-ray Detection Feature is substantially equivalent to the cleared predicate Wired/Wireless FDR D-EVO Flat Panel Detector and conforms to applicable medical device safety standards

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's emblem on the left, which features a stylized human figure. To the right of the emblem, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is displayed in a clear, sans-serif font. The overall design is simple and professional, reflecting the department's role in public health and human services.

Public Health Service

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

Ms. Debra A. Peacock Regulatory Affairs Manager Fuji Medical Systems U.S.A., Inc. 419 West Avenue STAMFORD CT 06902

AUG 2 3 2013

Re: K11865

Trade/Device Name: Wireless/Wireless FDR D-EVO with X-ray Detection Feature Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: August 16, 2011 Received: August 17, 2011

Dear Ms. Peacock:

This letter corrects our substantially equivalent letter of September 30, 2011.

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 for use stated in the encreated 776, 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 I va may, morelore, mains 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 or any I cuttar statutes and reguirements, 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 (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 notheation. The FDF imanis of fication 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 11 you done specific de rice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket s 150. Thise, process now are roganized on 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 Totallay 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

Acting 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): Kl (845

Device Name: Wired/Wireless FDR D-EVO with X-ray Detection Feature

Indications for Use:

ess

Prescription Use × (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 Stattl

Division Sign-Off

Office of In Vi

510K K111865

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.