Dynamic Visualization II Image Processing is an optional software for the FDX Console, intended to provide optimized image quality over a wide range of patient thicknesses, especially for bariatric imaging. The device is not intended for mammography use.

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 svstems. 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 Acquisition Workstation for the DR-ID600 is the FDX Console. Dynamic Visualization II Image Processing (DVII) is optional software included in v9.0 of the FDX Console. The FDX Console and Dynamic Visualization II software may be used with Fujifilm DR and CR X-ray systems.

Dynamic Visualization II is an enhanced version of Fujifilm's Dynamic Visualization™ (DV) image processing software. The enhancements made to DVII are designed to provide optimized image quality over a wide range of patient thicknesses, and can be particularly useful when imaging bariatric patients.

DVII uses the same image processing sequence as the predicate DV, but the EDR (Exposure Data Recognition) and MFP (Multi-objective Frequency Processing) algorithms have been modified. When compared to the current EDR and MFP algorithms, the corresponding new algorithms (EDR2, MFP2) have been modified as follows:

EDR2 - to identify and optimize various anatomic structures in an acquired image prior to the subsequent application of contrast and sharpness image processing steps, EDR2 uses a feature recognition method as opposed to conventional EDR's histogram analysis method.

MFP2 - similar to MFP, MFP2 sharpens and balances contrast in anatomic structures in an image after being subject to Exposure Data Recognition. MFP2 uses additional low frequency tables and a combination of automatic and preset dynamic range control operations.

AI/ML Overview

Here's an analysis of the provided information regarding the acceptance criteria and study for the Dynamic Visualization II Image Processing Option:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, the "acceptance criteria" are implied by the comparative image quality evaluation, which aimed to show that the new processing option (DV2) optimizes image quality relative to the predicate (DV), especially for bariatric patients.

Implied Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Image quality optimization for all patient thicknesses	The evaluation "demonstrates that DV2 optimizes image quality for all patients."
Improved image quality for bariatric patients	The evaluation "demonstrates that DV2 optimizes image quality for all patients, even when images of larger patients are processed using the proposed, modified device." (This implicitly covers bariatric patients as "larger patients" and notes their specific inclusion in the study design).
Device is as safe and effective as the predicate	"FMSU concludes the Dynamic Visualization II Image Processing Option... is as safe and effective as the legally marketed device K153464 and does not raise different questions of safety and effectiveness than K153464."
Conformity to voluntary standards (e.g., AAMI/ANSI ES60601-1)	"The conformity 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 remains unaffected."
Satisfactory verification and validation of improvements	"all verification and validation activities related to the improvements made to the Dynamic Visualization II Image Processing Option were performed and the results were satisfactory."

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: The document states that "Raw clinical images were processed" and "Randomized image pairs (DV vs. DV2) were then evaluated." However, the exact number of images in the test set is not specified.
- Data Provenance: The data consisted of "Raw clinical images," but the country of origin is not specified. It is stated that "Slightly more than half of the images were of bariatric patients," indicating a focus on a specific patient demographic relevant to the device's indications for use. The study is retrospective as it used "Raw clinical images" that were then processed by both the predicate and proposed algorithms.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Three readers evaluated the randomized image pairs.
- Qualifications of Experts: The qualifications of these readers are not specified. It is only mentioned that they were "readers," implying they are likely medical professionals, but their specific specialty (e.g., radiologist) and experience level are not provided.
Adjudication method for the test set:
- The document states that "Randomized image pairs (DV vs. DV2) were then evaluated by three readers." It does not specify an explicit adjudication method like 2+1 or 3+1. The phrasing suggests individual evaluations by each reader rather than a consensus-building process with formal adjudication rules.
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:
- A comparative effectiveness study was performed, focusing on the image processing algorithms (DV vs. DV2) rather than direct AI assistance to human readers. The study compared images processed by the predicate algorithm to images processed by the new algorithm. It was a "comparative image quality evaluation" where "Randomized image pairs (DV vs. DV2) were then evaluated by three readers."
- This was not an MRMC study comparing human readers with vs. without AI assistance. It was a comparison of two different image processing algorithms applied to images, and human readers then evaluated the quality differences between the outputs of these algorithms. Therefore, an effect size of human readers improving with/without AI assistance is not applicable in this context. The study aimed to show the new algorithm itself produces better images.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The study implicitly involves a standalone performance aspect if you consider the algorithms' ability to process images. The output of the algorithms (processed images) was then directly evaluated by human readers. However, the direct performance of the algorithm without human evaluation is not specifically detailed or presented (e.g., objective metrics of image quality without human perception). The evaluation method involved human readers assessing the output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the "image quality optimization" was based on the evaluation of three readers (experts). There's no mention of pathology, outcomes data, or a formal expert consensus process to establish ground truth in the sense of a definitive diagnostic label. The evaluation was relative: which processed image (DV or DV2) looked "better" or "optimized."
The sample size for the training set:
- The document does not specify the sample size for any training set. The device is described as an enhanced image processing software (Dynamic Visualization II) with modified algorithms (EDR2, MFP2) from a predicate (Dynamic Visualization), not necessarily a machine learning model that requires a distinct training set. While these algorithms were "modified," the process of their development or any explicit "training" of a machine learning model with a defined training set size is not detailed.
How the ground truth for the training set was established:
- As no training set is explicitly mentioned or detailed, the method for establishing its ground truth is not provided. The changes are described as modifications to existing image processing algorithms (EDR and MFP), suggesting an engineering or algorithmic refinement process rather than, for example, supervised machine learning requiring labeled training data.

Summary

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

August 31, 2017

FUJIFILM Medical Systems U.S.A., Inc. % Dharaben Desai Sr. Regulatory Affairs Specialist 419 West Avenue STAMFORT CT 06902

Re: K163624

Trade/Device Name: Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: May 23, 2017 Received: May 24, 2017

Dear Dharaben Desai:

This letter corrects our substantially equivalent letter of June 30th, 2017. 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/ResourcesforYou/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,

Robert Ocks

Robert Ochs, Ph.D. 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)

Device Name

Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600).

Indications for Use (Describe)

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

2 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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510(k) Summary

Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of DR-ID600)

Date: May 23, 2017

Submitter's Information:

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

Contact Person:

Name:	Dharaben Desai
Title:	Sr. Regulatory Affairs Specialist
Telephone:	(203) 276-3445
Facsimile:	(203) 602-3785

Identification of the Device:

Proprietary/Trade Name:	Dynamic Visualization II Image Processing Optionfor the FDX Console (DR-ID300CL of DR-ID600)
Classification Name:	Stationary X-ray system
Regulations Number:	21 CFR 892.1680
Product Codes:	MQB
Device Class:	Class II
Review Panel:	Radiology
Common Name:	Flat Panel Digital Detector System

Identification of the Legally Marketed Predicate Device:

FDR D-EVO Flat Panel Detector System (DR-ID600) with Improved Virtual Grid Software, K153464 cleared 4/8/2016

l. DEVICE DESCRIPTION

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II. INDICATIONS FOR USE

. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

FDR D-EVO FPD System (DR-ID600) continues to offer 600 series detectors with two different scintillator materials - GOS (Gadolinium oxysulfide) or Csl (Cesium lodide) - and various detector sizes to choose from. All detector characteristics including indirect conversion method using Fujifilm's unique Irradiated Side Sampling (ISS) technology, pixel pitch (150µm), resolution (16 bit), DQE (Detective Quantum Efficiency) measurements, MTF (Modulation Transfer Function) performance remains the same. The wireless communication feature, and automatic x-ray detection function (known as 'SmartSwitch' in the US) also stay unaffected by the changes. The same acquisition workstation, FDX Console will continue to support FDR D-EVO FPD System (DR-ID600). FDX Console v9.0 or later will release the Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600).

	Subject/Modified DeviceDynamic Visualization II ImageProcessing Option for the FDXConsole (DR-ID300CL of the DR-ID600)	Predicate DeviceFDX Console (DR-ID300CL) WithVirtual Grid Software Optionfor the FDR D-EVO FPD system (DR-ID600)(K153464 cleared 4/8/2016)
Indications for Useof the DR D-EVOFPD system DR-ID600	The Wireless/Wired FDR D-EVO flatpanel detector system is intended tocapture for display radiographicimages of human anatomy. It is	The Wireless/Wired FDR D-EVO flatpanel detector system is intended tocapture for display radiographicimages of human anatomy. It is
	Subject/Modified Device	Predicate Device
	Dynamic Visualization II ImageProcessing Option for the FDXConsole (DR-ID300CL of the DR-ID600)	FDX Console (DR-ID300CL) WithVirtual Grid Software Optionfor the FDR D-EVO FPD system (DR-ID600)(K153464 cleared 4/8/2016)
(unchanged)	intended for use in general projectionradiographic applications includingpediatric and neonatal examswherever conventional film /screenor CR systems may be used. TheFDR D-EVO is not intended formammography, fluoroscopy,tomography, and angiographyapplications.	intended for use in general projectionradiographic applications includingpediatric and neonatal examswherever conventional film /screen orCR systems may be used. The FDRD-EVO is not intended formammography, fluoroscopy,tomography, and angiographyapplications.
Indications for usefor option	Dynamic Visualization II ImageProcessing is an optional softwarefor the FDX Console, intended toprovide optimized image quality overa wide range of patient thicknesses,especially for bariatric imaging. Thedevice is not intended formammography use.	The FDR D-EVO can be used withVirtual Grid Software, which isoptional image processing softwareinstalled on Fujifilm's FDX Console.Virtual Grid Software can be used inlieu of an anti-scatter grid to improveimage contrast in generalradiographic images by reducing theeffects of scatter radiation.
Option for	Same as Predicate	FDX Console of the Wireless/WiredFDR D-EVO flat panel detectorsystem DR-ID600
	Image Processing Characteristics
DynamicVisualizationAlgorithm	DV II uses a combination of EDR2and MFP2	DV uses a combination of EDR andMFP
Exposure DataRecognizerAlgorithm (EDR)	EDR2- to identify and optimizevarious anatomic structures in anacquired image prior to thesubsequent application MFP2processing, EDR2 uses a featurerecognition method to identifydirect x-ray, bone, tissue, andartificial object regions	EDR- uses the conventional histogramanalysis method prior to thesubsequent application MFPprocessing.
Frequency NoiseControl (FNC)	Same as Predicate	Performs noise suppression
Multi objectiveFrequencyProcessing (MFP)	MFP2 performs Spatial FrequencyEnhancement and DynamicRange Control similar to that ofMFP, but with two new lowerfrequency bands and automatedDynamic Range Control Features.	MFP performs Spatial FrequencyEnhancement and Dynamic RangeControl using six frequency bands andfixed Dynamic Range ControlFeatures.
GradationProcessing (Gp)	Same	Performs global brightness andcontrast adjustment following MFPprocessing.
	Miscellaneous
Available flat paneldetectors	Same	Same
Detector WirelessFeatures	Same	Same
	Subject/Modified Device	Predicate Device
	Dynamic Visualization II ImageProcessing Option for the FDXConsole (DR-ID300CL of the DR-ID600)	FDX Console (DR-ID300CL) WithVirtual Grid Software Optionfor the FDR D-EVO FPD system (DR-ID600)(K153464 cleared 4/8/2016)
Auto X-ray detectionfeature	Same	Same
WorkstationSoftware Version	Same as Predicate	FDX Console Version 9.0
Minimum BasicComputerConfiguration (asprovided in US)	Model: HP ProDesk 600 G2 SeriesSmall Form Factor PCProcessor: Intel Core i5-6500 with3.2GHzRAM: 4GB (4x1GB)Hard Drive: 500GBCD/DVD: Slim SuperMulti DVDdriveDisplay: 17 " or 21" color(touchscreen optional) Monitor.Accessories: Keyboard, Mouse,Barcode scanner	Model: Mini TowerProcessor: Core 2 DuoRAM: 2GBHard Drive: 80GBCD/DVD: DVD driveDisplay: 17 " or 21" color (touchscreenoptional) Monitor.Accessories: Keyboard, Mouse,Barcode scanner
Operating System	Windows 7 Professional 32-bit	Windows Vista/Windows 7Professional 32-bit
Image Transfer	Same as Predicate	Standard network connectivity viaDICOM protocol & via Fuji DMSNetwork

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IV. SUBSTANTIAL EQUIVALENCE

The FDR D-EVO FPD System (DR-ID600) with the Dynamic Visualization II Image Processing Option 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)with Improved Virtual Grid Software	K153464	4/8/2016

The FDX Console version 9.0 software was cleared with the FDR D-EVO FPD System (DR-ID600) in K153464. The FDR D-EVO's detector characteristics as well as other maior features such as wireless communication and automatic x-rav detection function ('SmartSwitch') remain unchanged. The FDR D-EVO can be used with or without the Dynamic Visualization II Image Processing Option, and the improvements do not affect the intended use or alter the fundamental scientific technology of the legally marketed device. The only change between the predicate device and the proposed device of this submission is the addition of the Dynamic Visualization II Image Processing Option, which is an improvement of the Dynamic Visualization option available with the predicate device.

V. SUMMARY OF STUDIES

Non-clinical Performance Data: The conformity 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 remains unaffected. As required by the risk analysis, all verification and validation activities related to the improvements made to the

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Dynamic Visualization II Image Processing Option were performed and the results were satisfactory.

FUJIFILM conducted a comparative image quality evaluation between the predicate device Dynamic Visualization (DV) and the proposed modified device, Dynamic Visualization II (DV2). Raw clinical images were processed with the predicate image processing algorithms (DV), and then the raw images were processed using the proposed image processing algorithms (DV2). Randomized image pairs (DV vs. DV2) were then evaluated by three readers. Slightly more than half of the images were of bariatric patients. The results of the evaluation demonstrates that DV2 optimizes image quality for all patients, even when images of larger patients are processed using the proposed, modified device.

Clinical Performance Data: The changes do not require clinical studies. The substantial equivalence has been demonstrated by non-clinical studies.

VI. CONCLUSION

Based upon the supporting data summarized above. FMSU concludes the Dynamic Visualization II Image Processing Option offered with FDR D-EVO Flat Panel Detector System (DR-ID600) is as safe and effective as the legally marketed device K153464 and does not raise different questions of safety and effectiveness than K153464.

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.