The WirelessMired 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-EVQ 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 acquires and digitizes x-ray exposures from standard radiographic systems. It is designed to be used in any environment that would typically use a radiographic cassette. It 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 FDR D-EVO FPD system is currently indicated for general projection radiographic applications and offers two different detector types in terms of scintillator materials (gadolinium oxysulfide (GOS) and cesium iodide (Csl)). The new submission is being submitted for the same FDR D-EVO FPD system to seek the clearance of the pediatric indication for use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Fujifilm FDR D-EVO Flat Panel Detector System (DR-ID600), based on the provided text:

Acceptance Criteria and Device Performance

The provided document (a 510(k) summary) doesn't explicitly list specific quantitative "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity, or image quality metrics with thresholds). Instead, it states the device conforms to voluntary standards and provides acceptable diagnostic capability and image quality at reasonably low dose levels for pediatric use. The "reported device performance" is qualitative and based on expert evaluation.

Acceptance Criterion (Implicit)	Reported Device Performance
Conformance to voluntary standards	Conforms to IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-4, UL60601-1, and DICOM. The standardized dose index (Exposure Index (EI) and Deviation Index (DI)) comply with IEC 62494-1. Flat panel detector characteristics described per FDA Guidance for 510(k)'s for Solid State X-ray Imaging Devices (1999) fundamentally remain unchanged.
Acceptable diagnostic capability for pediatric use	Evaluation by a pediatric radiologist concluded that, when used with Fujifilm's recommended exposure conditions, the FDR D-EVO FPD system (both GOS-based and CsI-based panels) can provide acceptable diagnostic capability for pediatric patients.
Acceptable image quality at reasonably low dose for pediatric use	Evaluation by a pediatric radiologist concluded that, when used with Fujifilm's recommended exposure conditions, the FDR D-EVO FPD system (both GOS-based and CsI-based panels) can provide acceptable image quality at reasonably low dose levels typically used for pediatric use. The results of this image quality evaluation and dose assessment are explicitly stated to be provided in the submission.

Study Details

Sample size used for the test set and data provenance:
- Test Set Sample Size: The document states that images were acquired "using phantoms that mimicked the pediatric subgroups." It does not provide a specific numerical sample size (e.g., number of phantom images or specific phantom types) for this test set.
- Data Provenance: The data was generated through laboratory testing using phantoms. The country of origin is not explicitly stated, but the submission is from FUJIFILM Medical Systems U.S.A., Inc. This was a prospective study as it involved acquiring new images for the evaluation.
Number of experts used to establish the ground truth for the test set and their qualifications:
- Number of Experts: Singular: "a pediatric radiologist."
- Qualifications: "with experience in evaluating patient images and images of pediatric phantoms."
Adjudication method for the test set:
- The document mentions evaluation by "a pediatric radiologist," implying no multi-reader adjudication method (e.g., 2+1 or 3+1). It appears to be a single-reader evaluation.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
- No. The document describes an image quality evaluation by a single pediatric radiologist using phantoms. It does not mention an MRMC study or a comparison of human readers with vs. without AI assistance. The device itself is a flat panel detector, not an AI-assisted diagnostic tool in the sense of providing algorithmic interpretations for comparison with human readers.
If a standalone study (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not directly applicable in the typical sense for this type of device. The FDR D-EVO is a hardware component (a flat panel detector) that acquires images, not an algorithm that interprets them. The "performance" being evaluated here is the image quality and diagnostic capability derived from the detector's output, which is then assessed by a human expert. The study essentially is a standalone evaluation of the device's capability to produce images suitable for diagnostic interpretation across pediatric subgroups.
The type of ground truth used:
- The ground truth was established through expert consensus/evaluation by a pediatric radiologist evaluating images from phantoms designed to mimic pediatric subgroups. The phantoms themselves provide a known "truth" (e.g., structures, densities) which the radiologist assesses in the acquired images for diagnostic capability and image quality.
The sample size for the training set:
- The document does not mention a training set. This device is a digital X-ray detector, and its primary function is image acquisition, not complex image analysis or AI interpretation that would typically require a training set in the context of machine learning. The focus of the submission is on hardware performance and image output suitability.
How the ground truth for the training set was established:
- Not applicable, as no training set is mentioned or implied for this device's function.

Summary

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R132509
page 1 of 2

510(k) Summary

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

Date: November 25, 2013

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 Proposed Device:

Proprietary/Trade Name: Classification Name: Regulations Number: Product Codes: Device Class: Review Panel: Common Name:

FDR D-EVO Flat Panel Detector System (DR-ID600) Stationary x-ray system 21 CFR 892.1680 90 MQB Class II Radiology Flat Panel Digital Detector

1. INDICATIONS FOR USE

II. DEVICE DESCRIPTION

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K132509
Page 2 of 2

Image /page/1/Picture/1 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, in a smaller font, it says "Fujifilm Medical Systems, USA". The logo is simple and modern, and it is likely used on the company's products and marketing materials.

SUMMARY OF STUDIES III.

The subject device, FDR D-EVO FPD system (DR-ID600) conforms to the voluntary standards such as IEC60601-1. IEC60601-1-1. IEC60601-1-2. IEC60601-1-4. UL60601-1 and DICOM. The newly adapted standardized dose index. Exposure Index (EI) and Deviation Index (DI), comply with the international standard IEC 62494-1. In addition, the flat panel detector characteristics described per the FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, (issued on August 6, 1999) fundamentally remains unchanged.

Following the FDA's recommendations of the recently published DRAFT guidance document, Pediatric Information for X-ray Imaging Device Premarket Notifications (issued on May 10, 2012), additional laboratory testing data are provided in the submission and an image quality evaluation was performed.

The images using phantoms that mimicked the pediatric subgroups were acquired with each detector type (GOS and Csl) and these images were evaluated by a pediatric radiologist with experience in evaluating patient images and images of pediatric phantoms. Based on the results of this evaluation, Fujifilm concludes that, when used in conjunction with Fujifilm's recommended exposure conditions as a reference, the FDR D-EVO FPD system with both GOS-based and Csl-based panels can provide acceptable diagnostic capability and image quality at reasonably low dose levels typically used for pediatric use. The results of this image quality evaluation and dose assessment are provided in the submission.

SUBSTANTIAL EQUIVALENCE IV.

Fujifilm's FDR D-EVO Flat Pane! Detector System (DR-ID600) is substantially equivalent to the following legally marketed devices.

Legally Marketed Device	510(k) #	Clearance date
Wireless/Wired FDR D-EVO flat paneldetector system (DR-ID600 w/DR-ID601SE)	K103596	03/29/2011
Wireless/Wired FDR D-EVO flat paneldetector system (DR-ID600 w/DR-ID611SE)	K111548	08/30/2011

The Indication For Use (IFU) of the subject device has been updated to specify pediatric and neonatal exams, and corresponding labeling change has occurred to provide the user more information on how to use the subject device in pediatric exams. However no major design, software, and material changes have occurred to support a pediatric indication.

The subject device's detector characteristics including Fujifilm's unique Irradiated Side Sampling (ISS) design delivering high image quality and wireless communication specifications remain unchanged, and the device maintained fundamentally same functional and technical requirements as the predicate devices.

V. CONCLUSION

We concluded the FDR D-EVO Flat Panel Detector System (DR-ID600) is as safe and effective as the legally marketed devices for the proposed Indications For Use based upon the studies summarized above.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the seal is a stylized symbol resembling an abstract human figure or a bird in flight, composed of three curved lines.

ood and Drug-Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

November 25. 2013

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

Re: K132509

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: MQB Dated: November 11, 2013 Received: November 12, 2013

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

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Page 2- Ms. Katherine Choi

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 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.fda.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/MedicalDevices/Safety/ReportalProblem/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/Medica]Devices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K132509

Device Name

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

Indications for Use (Describe)

The Wireless/Wired FDR D-EVO flat panel detector system is intended to caplare for display radiographic images of human anatomy. It is intended for use in general projections including pediatic and neonatal exams wherever conventional film/screen or CR systems may be used. The FDR D-EVO is not intended for mammography, fluoroscopy, and angiography applications.

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

[X] 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)

Sm.h.7)

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.