VIVIX-S 1751S series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film/ screen systems. The VIVIX-S 1751S series is not intended for mammography applications.

Device Description

VIVIX-S 1751S, whose model name is VIVIX-S 1751S with 17X51 inches of imaging area. The device intercepts x-ray photons, and its Gadox (Gadolinium Oxysulfide) scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)-detectors that create electrical signals. After the electrical signals are generated, it is converted to digital value, and the software acquires and processes the data values from the detector. The resulting digital images will be displayed on monitors. These devices should be integrated with an operating PC and an X-Ray generator. The detector can communicate with the generator by cable. It is utilized for capturing and transfer of digital x-ray images for radiography diagnosis. The X-ray generator and the imaging software are not part of the VIVIX-S 1751S.

AI/ML Overview

Acceptance Criteria and Study for VIVIX-S 1751S Digital X-ray Detector

The VIVIX-S 1751S Digital X-ray detector was evaluated for substantial equivalence to its predicate device (K181003, VIVIX-S 1717V) through non-clinical performance testing and a clinical image concurrence study.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the VIVIX-S 1751S are based on demonstrating performance equivalent to or better than the predicate device (VIVIX-S 1717V). Specifically, the device was tested against recognized performance metrics for X-ray detectors.

Parameter	Acceptance Criteria (Predicate Device K181003)	Reported Device Performance (VIVIX-S 1751S)	Met Acceptance Criteria?
Image Quality
DQE (1lp/mm)	FXRD-1717VA: 40~~60 (typ. 48%)FXRD-1717VB: 20~~40 (typ. 27%)	FXRD-1751SB: 20% (for Gd2O2S:Tb scintillator)	Equivalent
MTF (1lp/mm)	FXRD-1717VA: 50~~70 (typ. 70%)FXRD-1717VB: 40~~60 (typ. 58%)	FXRD-1751SB: 40% (for Gd2O2S:Tb scintillator)	Equivalent
Resolution	3.5 lp/mm	3.5 lp/mm	Yes
Pixel Pitch	0.14mm	0.14mm	Yes
Active Area	430.08 x 430.08 (mm)	430.08(mm) x 430.08(mm)430.08(mm) x 860.16(mm)430.08(mm) x 1290.24(mm)	Yes (offers larger options)
Pixel Size	140 μm	140 μm	Yes
Grayscale	16 bit	16 bit	Yes
Spatial Resolution	3.5lp/mm	3.5lp/mm	Yes
Functional Equivalence
Intended Use	General diagnostic procedures, replace film/screen systems, not mammography.	General diagnostic procedures, replace film/screen systems, not mammography.	Yes
Operating Principle	X-ray photons strike scintillator, visible light, electric charge, digital value.	X-ray photons strike scintillator, visible light, electric charge, digital value.	Yes
Design Features	Similar to predicate	Similar to predicate	Yes
Communication Method	Wired, Max. 1Gbps	Wired, Max. 1Gbps	Yes
Scintillator Materials	Gd2O2S:Tb, Csl:TI	Gd2O2S:Tb (Csl:TI type not available for this model)	Equivalent
Active Array	3072 x 3072 pixels	3072 x 3072 pixels3072 x 6144 pixels3072 x 9216 pixels	Yes (offers larger options)
Method of Generator Interface	DR Trigger, AED, Passive Trigger	DR Trigger, AED	Equivalent (Passive Trigger omitted)
Technology	Structured scintillator for efficiency and resolution.	Structured scintillator for efficiency and resolution.	Yes
Principle of Operation	X-ray conversion to visible light then electric charge.	X-ray conversion to visible light then electric charge.	Yes

Note: While the exact DQE and MTF values vary for the specific FXRD-1751SB model compared to some predicate models (FXRD-1717VA vs FXRD-1717VB), the applicant states "Similar performance as follow" and declares the performance as "Equivalent," suggesting the overall performance is within an acceptable range for substantial equivalence.

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

The provided summary does not explicitly state the specific sample size used for the clinical image concurrence study test set. It mentions "a single-blinded concurrence study." The data provenance (e.g., country of origin, retrospective or prospective) for this clinical study is also not detailed in the provided information.

3. Number of Experts and Qualifications for Ground Truth

The number of experts used to establish the ground truth for the clinical test set and their specific qualifications (e.g., "radiologist with 10 years of experience") are not specified in the provided 510(k) summary. It only indicates that "CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices was conducted" and that it was a "single-blinded concurrence study."

4. Adjudication Method

The adjudication method for the test set is not explicitly stated. The summary mentions "a single-blinded concurrence study," which implies a comparison of images by experts, but the process for resolving disagreements or establishing a final ground truth is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to assess how much human readers improve with AI vs. without AI assistance. The device is a digital X-ray detector, not an AI-powered diagnostic tool, and the study described is a comparison of image diagnostic capability between two detector models.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study of the algorithm only without human-in-the-loop performance is not applicable in the context of this device. The VIVIX-S 1751S is a digital X-ray detector, a hardware component that produces images for human interpretation, not an independent algorithm for diagnosis. The non-clinical performance (DQE, MTF, resolution) can be considered "standalone" in terms of objective image quality metrics of the device itself.

7. Type of Ground Truth Used

For the clinical study, the ground truth was established through expert concurrence. The summary states that the study "confirmed that the new x-ray detectors VIVIX-S 1751S provide images of equivalent diagnostic capability to the predicate devices." This implies that expert readers (though unspecified in number or qualifications) evaluated the images and concurred on their diagnostic equivalence. Pathology or outcomes data are not mentioned as the ground truth.

8. Sample Size for the Training Set

The provided 510(k) summary describes a digital X-ray detector, which is a hardware device for image acquisition. This device does not have a "training set" in the context of artificial intelligence or machine learning algorithms. Its design and performance are based on physical and technical specifications.

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

As clarified in point 8, the concept of a "training set" and associated "ground truth" for a training set is not applicable to this device as it is a digital X-ray detector, not an AI/ML diagnostic software. The performance evaluations are based on engineering specifications and clinical comparison to a predicate device.

Summary

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510(k) Summary

[As required by 21 CFR 807.92]

K190611

This 510(k) summary information is prepared in accordance with 21 CFR807.92

1. Date Prepared [21 CFR 807.92(a) (1)]

03/28/2019

2. Submitter's Information [21 CFR 807.92(a) (1)]

Name of Sponsor: Vieworks Co., Ltd. (Gwanyang-dong) 41-3, Burim-ro 170beon-gil,Dongan-gu, Address: Anyang-si, Gyeonggi-do, 431-060 Republic of Korea Contact Name: Kim, Jordin / Regulatory Affairs Associate Registration Number: 3006013411 Name of Manufacturer: Same as Sponsor

3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]

Trade Name:	VIVIX-S 1751S
Model Name:	VIVIX-S 1751S
Common Name:	Digital Flat Panel X-ray Detector
Regulation Name:	Stationary X-Ray System
Classification Panel:	Radiology
Regulation Number:	21 CFR 892.1680
Product Code:	MQB
Device Class:	2

4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]

510(k) Number:	K181003
Applicant:	Vieworks Co., Ltd.
Decision Date:	03/15/2018
Type:	Traditional
Trade Name:	VIVIX-S 1717V
Model Name:	FXRD-1717VAFXRD-1717VB
Common Name:	Digital Flat Panel X-ray Detector
Regulation Name:	Stationary X-Ray System
Classification Panel:	Radiology
Regulation Number:	21 CFR 892.1680
Product Code:	MQB
Device Class:	2

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5. Description of the Device [21 CFR 807.92(a) (4)]

o General Description

6. Indications for Use [21 CFR 807.92(a)(5)]

VIVIX-S 1751S series is used for the general-purpose diagnostic procedures, and as intended to replace radiographic film/ screen systems. The VIVIX-S 1751S series is not intended for mammography applications.

7. Technological Characteristics [21 CFR 807.92(a) (6)]

Comparisons with the predicate, devices show the technological characteristics of the proposed VIVIX-S 1751S device to be substantially equivalent to the predicate devices. The proposed devices are functionally identical to the predicate devices.

8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]

When compared to the predicate devices (K181003), the VIVIX-S 1751S presented in this submission has the same:

Intended Use
Operating principle
· Design features
Communication Method
Scintillator Materials
Resolution

There is similar performance as follow.

Performance (MTF)
Performance (DQE)

For the predicate device, VIVIX-S 1717V, only one panel (for 17x17 inch imaging) is used. For this type of detector to capture images for longer body parts such as whole spine or legs, an imaging process (stitching) on the 3 separately taken images from 3 exposures are required to create one long image.

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On the other hand, the VIVIX-S 1751S detector features 3 of the panels to create longer images (17 x 34 inches and 17x51 inches) for single exposure and without the stitching process. 17 x 17 size image can be also captured with this type of detector as well.

Parameter	Predicate Device	Subject Device	Equivalence
510(k) Number	K181003	-	-
Manufacturer	Vieworks Co., Ltd.	-	-
Device Name	VIVIX-S 1717V	VIVIX-S 1751S	-
Detector	FXRD-1717VA,FXRD-1717VB	FXRD-1751SB	-
Power SupplyUnit	-	FXRP-01A	Power Supply
IO Box	FXRI-01A	-	Power Supply
Software	VXvue	-	Software
Common Name	Digital Flat Panel X-ray Detector		Equivalent
ClassificationName	Solid State X-Ray Imager (Flat Panel/Digital Imager)		Equivalent
ClassificationPanel	Radiology		Equivalent
ClassificationRegulation	21 CFR 892.1680		Equivalent
Product Code	MQB		Equivalent
Device Class	2		Equivalent
Intended Use	VIVIX-S 1717V series is indicatedfor digital imaging solutiondesigned as a generalradiographic system for humananatomy. It is intended toreplace film or screen basedradiographic systems in allgeneral purposes of diagnosticprocedures. It is not to be usedfor mammography.	VIVIX-S 1751S series is usedfor the general-purposediagnostic procedures, andas well as intended toreplace radiographic film/screen systems. The VIVIX-S1751S series is not intendedfor mammographyapplications.	Equivalent

Parameter		Predicate Device	Subject Device	Equivalence
	Device Name	VIVIX-S 1717V	VIVIX-S 1751S	-
	Panel Shape	Square Panel	Square Panel	Equivalent
Design	Field of View	17 x 17inch	17 x 51inch	3 timeslonger*
	Dimensions(H x W x D)	460.0 x 460.0 x 15.5mm	1357.0 x 532.0 x30.0mm	Equivalent
	Pixel Pitch	0.14mm	0.14mm	Equivalent
	Weight	4.5kg	About 4.5kg	Equivalent
	MaterialsScintillator		Csl: TI,Gd2O2S:Tb	Gd2O2S:Tb

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Image sensor		TFT: a-Si (Amorphous Silicon)	TFT: a-Si (Amorphous Silicon)	Equivalent
DataTransmis-sion	Wired	Max. 1Gbps	Max. 1Gbps	Equivalent
CommunicationMethod	Wired	Wired	Wired	Equivalent
Performa-nce	DQE(1lp/mm)	FXRD-1717VA:40~~60 (typ. 48%)FXRD-1717VB:20~~40 (typ. 27%)	Csl Type Not AvailableFXRD-1751SB:20%	Equivalent
	MTF(1lp/mm)	FXRD-1717VA:50~~70 (typ. 70%)FXRD-1717VB:40~~60 (typ. 58%)	Csl Type Not AvailableFXRD-1751SB:40%	Equivalent
	Resolution	3.5 lp/mm	3.5 lp/mm	Equivalent
	Active Area	430.08 x 430.08 (mm)	430.08(mm) x 430.08(mm)430.08(mm) x 860.16(mm)430.08(mm) x 1290.24(mm)	The candidate device features 3 of the panels used for the predicate device.
Pixel Size		140 μm	140 μm	Equivalent
Grayscale		16 bit	16 bit	Equivalent
Image AcquisitionTime		1.5 sec. (wired)	10 sec.	Longer
Active Array		3072 x 3072 pixels	3072 x 3072 pixels3072 x 6144 pixels3072 x 9216 pixels	Equivalent
Method ofGenerator Interface		• DR Trigger (External Line Trigger)• AED (Auto Exposure Detection)• Passive Trigger (External Line Trigger)	• DR Trigger (External Line Trigger)• AED (Auto Exposure Detection)	Equivalent


Spatial Resolution		3.5lp/mm	3.5lp/mm	Equivalent
Technology		Structured scintillator is attached in the detector to increase the X-ray photon interaction, X-ray absorption, and the amount of available visible light. This enhances potential	Structured scintillator is attached in the detector to increase the X-ray photon interaction, X-ray absorption, and the amount of available visible light. This enhances potential	Equivalent
	efficiency and partialresolution.	efficiency and partialresolution.
Principle ofOperation	Generated X-rayphotons strike thescintillator causing thevisible light emissionthat is to be convertedinto an electric chargeby the photodiodearray. The electriccharge is then collectedat each photodiode andturns into a digitalvalue by using theunderlying readoutelectronics.	Generated X-rayphotons strike thescintillator causing thevisible light emissionthat is to be convertedinto an electric chargeby the photodiodearray. The electriccharge is then collectedat each photodiode andturns into a digitalvalue by using theunderlying readoutelectronics.	Equivalent

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9. Summary of Non-Clinical Data

A comparison test was conducted between the subject devices (VIVIX-S 1751S) and the predicate device (K181003) on the items such as DQE, MTF and spatial resolution.

These detectors comply with the following international and FDA-recognized consensus standards:

· 21CFR1020.30, Diagnostic X-ray Systems and their major components
· 21CFR1020.31, Radiographic equipment
- IEC 60601-1 Medical Electrical Equipment -- Part 1: General Requirements for Basic Safety and Essential Performance.
CAN/CSA-C22.2 No. 60601-1 (2008) (Medical Equipment Part 1 : General Requirements for Basic Safety and Essential Performance) (includes National Differences for Canada)
ANSI/AAMI ES60601-1 (2005+ C1:09+A2:10) (Medical Electrical Equipment Part 1
IEC 60601-1-2 Medical Electrical Equipment Part 1-2 : General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
FDA guidance titled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"

10. Summary of Clinical Data

A single-blinded concurrence study according to CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices was conducted, and the study confirmed that the new x-ray detectors VIVIX-S 1751S provide images of equivalent diagnostic capability to the predicate devices, the VIVIX-S 1717V, and its results demonstrate substantial equivalence.

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11. Conclusion [21 CFR 807.92(b) (3)]

The VIVIX-S 1751S Digital X-ray detectors are substantially equivalent to the currently marketed and predicate devices (K181003) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.

Additionally, Substantial equivalence was demonstrated through the non-clinical performance, which complied with the requirements specified in the international and FDA-recognized consensus standards, IEC60601-1, IEC 60601-1-2, 3 and the clinical test, which complied with the requirements specified in the CDRH's Guidance for the Submission of 510(k)'s for Solid State Xray Imaging Devices.

The results of these tests demonstrate that VIVIX-S 1751S Digital X-ray detectors meets the acceptance criteria and is adequate for this intended use. The comparison of technological characteristics, non-clinical performance data, safety testing, and clinical image concurrence data demonstrates that the device is as safe, as effective, and performs as well the predicate devices.

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April 8, 2019

Image /page/6/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", and on the right, there is the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.

Vieworks Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 IRVINE CA 92620

Re: K190611

Trade/Device Name: VIVIX-S 1751S Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: March 5, 2019 Received: March 11, 2019

Dear Ms. Chung:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, 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) K190611

Device Name VIVIX-S 1751S

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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.