The Wireless/Wired 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 including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. The FDR D-EVO is not intended for mammography, fluoroscopy, tomography, and angiography applications.

Device Description

Fujifilm's FDR D-EVO Flat Panel Detector System (DR-ID600) is a portable digital detector system that interfaces with, and acquires and digitizes x-ray exposures, from standard radiographic systems. The FDR D-EVO is designed to be used in any environment that would typically use a radiographic cassette for examinations of adults, pediatrics and neonates. The detector models support both wireless and wired/tethered data communication between the detector and the system. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid exams.

The design modification made to the FDR D-EVO is adding Fujifilm's new post image processing algorithm called 'Virtual Grid Software'. The Virtual Grid Software is designed to improve image contrast in general radiographic images by reducing the effects of scatter radiation, primarily for exams acquired without a grid. Based on the displayed image, the user can decide whether or not to apply the Virtual Grid image processing by turning it ON or OFF as they see fit.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a modification to the Fujifilm FDR D-EVO Flat Panel Detector System (DR-ID600), specifically the addition of "Virtual Grid Software." This software is designed to improve image contrast by reducing scatter radiation effects, primarily for exams acquired without a physical grid.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria	Reported Device Performance
Effect on Image Contrast/Quality	Improvement in image contrast/quality for images acquired without an anti-scatter grid.	Bench testing and image quality evaluation demonstrated the Virtual Grid processing algorithm yields an improvement in image contrast and quality for those images acquired without an anti-scatter grid.
Safety and Effectiveness	As safe and effective as the legally marketed predicate device (K132509).	Concluded to be as safe and effective as K132509 and does not raise different questions of safety and effectiveness.
Intended Use	Does not affect the intended use of the previous cleared device.	Adding the Virtual Grid Software does not affect the intended use.
Fundamental Scientific Technology	Does not alter the fundamental scientific technology of the previous cleared device.	Does not alter the fundamental scientific technology.
Detector Characteristics	Detector characteristics (ISS design, wireless communication) remain unchanged.	Detector characteristics remain unchanged.
Functional/Technical Requirements	Virtually maintains the same functional and technical requirements as the currently-cleared predicate.	Virtually maintains the same functional and technical requirements.
Regulatory Compliance (Non-Clinical)	Conformance to voluntary standards.	Conforms to AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366, IEC 62494-1, and DICOM.
Risk Analysis	All verification and validation activities for the Virtual Grid Software performed and satisfactory.	All verification and validation activities for the Virtual Grid Software were performed and the results were satisfactory.

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

The document explicitly states: "Clinical Performance Data: The design modification does not require clinical studies. The substantial equivalence has been demonstrated by non-clinical studies." This indicates that no clinical test set was used for this specific modification. The evaluation relied on non-clinical data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable here in the context of a clinical test set.

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

Since no clinical test set was used for establishing ground truth related to patient images, this information is not applicable. The "image quality evaluation" mentioned under non-clinical performance data likely refers to technical assessments rather than expert clinical interpretations of diagnostic images from a patient dataset.

4. Adjudication method for the test set

Not applicable as no clinical test set was used requiring expert adjudication.

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 MRMC comparative effectiveness study was done. The document states that clinical studies were not required and that substantial equivalence was demonstrated by non-clinical studies. This modification is an image processing algorithm, not an AI-assisted diagnostic tool in the sense of improving human reader performance on a diagnostic task, but rather geared towards improving raw image quality.

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

Yes, a form of standalone evaluation of the algorithm's performance on image quality was done. The document states: "Additionally the bench testing and image quality evaluation further demonstrated the Virtual Grid processing algorithm yields an improvement in image contrast and quality, for those images acquired without an antiscatter grid." This indicates that the algorithm's output was assessed for its intended effect on image characteristics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical evaluation, the "ground truth" for the image quality assessment would likely be based on technical metrics of image contrast and visual assessment agreed upon by imaging engineers or possibly radiologists on technical merits, rather than clinical expert consensus on diagnostic findings, pathology, or outcomes data. The goal was to demonstrate improved contrast, not diagnostic accuracy in a clinical setting.

8. The sample size for the training set

The document does not specify the sample size for the training set for the Virtual Grid Software.

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

The document does not specify how the ground truth for the training set was established. It's important to note that "Virtual Grid Software" is described as a "post image processing algorithm." While some image processing algorithms can leverage machine learning and thus require training data and ground truth, the document doesn't provide details on its internal mechanisms beyond "reducing the effects of scatter radiation." If it's a rule-based or conventional signal processing algorithm, a "training set" with established ground truth in the machine learning sense might not be directly applicable. If it does involve machine learning, this information is not provided.

Summary

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

October 3, 2014

Fujifilm Medical Systems U.S.A., Inc. % Ms. Katherine Y. Choi Regulatory Affairs Lead 419 West Avenue STAMFORD CT 06902

Re: K141765

Trade/Device Name: FDR D-EVO Flat Panel Detector System (DR-ID600) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: September 2, 2014 Received: September 3, 2014

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. Please note: CDRH 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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.

Smh

for

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)

K141765

Device Name

FDR D-EVO Flat Panel Detector System (DR-ID600)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

[四] Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Attachment B: K141765, 510(k) Summary

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510(k) Summary

FDR D-EVO Flat Panel Detector System (DR-ID600)

Date: September 2, 2014

Submitter's Information:

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

Contact Person:

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

Identification of the Device:

Proprietary/Trade Name:	FDR D-EVO Flat Panel Detector System (DR-ID600)
Classification Name:	Stationary x-ray system
Regulations Number:	21 CFR 892.1680
Product Codes:	90 MQB
Device Class:	Class II
Review Panel:	Radiology
Common Name:	Flat Panel Digital Detector System

Identification of the Legally Marketed Device:

FDR D-EVO Flat Panel Detector System (DR-ID600), K132509 cleared 11/25/2013

l. DEVICE DESCRIPTION

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The Virtual Grid Software will be available as option to be installed with the FDR D-EVO's acquisition workstation, FDX Console. This Software will also be made available with all other legally marketed Fuiifilm DR Systems that use the FDX Console as the acquisition workstation, since this post-processing algorithm does not depend on how the image is acquired, or with what acquisition device.

-INDICATIONS FOR USE

. SUBSTANTIAL EQUIVALENCE

The modified FDR D-EVO FPD System (DR-ID600) is substantially equivalent to the following legally marketed device.

Legally Marketed Device	510(k) #	Clearance Date
FDR D-EVO Flat Panel Detector System (DR-ID600)	K132509	11/25/2013

Adding the Virtual Grid Software to FDR D-EVO (DR-ID600) does not affect the intended use or alter the fundamental scientific technology of the legally marketed device, K132509. The modified device's detector characteristics including Fujifilm's unique Irradiated Side Sampling (ISS) design delivering high image quality and wireless communication features remain unchanged, and the modified FDR D-EVO (DR-ID600) system virtually maintains the same functional and technical requirements as the currently-cleared predicate DR-ID600 system.

IV. SUMMARY OF STUDIES

Non-clinical Performance Data: The modified FDR D-EVO FPD System (DR-ID600) conforms to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366, IEC 62494-1 and DICOM. As required by the risk analysis, all verification and validation activities for the Virtual Grid Software were performed and the results were satisfactory. Additionally the bench testing and image quality evaluation further demonstrated the Virtual Grid processing algorithm yields an improvement in image contrast and quality, for those images acquired without an antiscatter grid. The results of the bench testing and image evaluation are provided in the submission.

Clinical Performance Data: The design modification does not require clinical studies. The substantial equivalence has been demonstrated by non-clinical studies.

V. CONCLUSION

Based upon the supporting data summarized above, we concluded the modified FDR D-EVO Flat Panel Detector System (DR-ID600) is as safe and effective as the legally marketed device K132509 and do not raise different questions of safety and effectiveness than K132509.

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.