VIVIX-S 1417N Series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film / screen systems. The VIVIX-S 1417N Series is not intended for mammography applications.

FXRD-1417NAW and FXRD-1417NBW are indicated for digital imaging solution designed as a general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purposes of diagnostic procedures. It is not to be used for mammography.

Device Description

Models FXRD-1417NAW and FXRD-1417NBW intercept X-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)-detectors that create an electrical signals. After the electrical signals are generated, these are converted to a digital value, and an image will be displayed on the monitor.

These devices should be integrated with an operating PC and an X-Ray generator to digitalize Xray images and transfer the digitalized images for radiography diagnostic.

Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, andimage information sharing on the network.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, specifically a digital flat panel X-ray detector (VIVIX-S 1417N). It focuses on demonstrating substantial equivalence to a predicate device (VIVIX-S 1717N), rather than providing detailed acceptance criteria and a study to prove meeting those criteria for an AI/CADe device.

Therefore, this document does not contain the information required to answer the prompt regarding acceptance criteria and a study proving a device meets those criteria, especially for an AI/CADe device.

The document details the technical characteristics and non-clinical and clinical data used to support the substantial equivalence claim for a hardware device (an X-ray detector). It does not describe the performance of an AI or CADe algorithm or a study designed to evaluate such a system against specific performance metrics for diagnostic accuracy.

Here's why the requested information cannot be found in the provided text:

No AI/CADe device: The VIVIX-S 1417N is an X-ray detector, which captures images. It is not an AI algorithm or a computer-aided detection (CADe) system that analyzes images for specific findings.
Focus on Substantial Equivalence: The entire submission is built around proving the new device is "substantially equivalent" to an existing predicate device based on similar intended use, technological characteristics, and performance, primarily in terms of image quality metrics (MTF, DQE, etc.).
"Clinical Data" section: While a "clinical data" section exists, it refers to a "single-blinded concurrence study" to confirm the new X-ray detectors provide "images of equivalent diagnostic capability" to the predicate devices. This is about image quality for human interpretation, not about the performance of an AI algorithm in detecting or diagnosing conditions, and it doesn't specify how "diagnostic capability" was quantified or what the acceptance criteria for it were. It serves to show the hardware works as intended for human readers.

To answer the prompt, I would need a document that describes the development and validation of an AI or CADe medical device, including:

Specific diagnostic task: What condition is the AI designed to detect or diagnose (e.g., lung nodules, fractures, diabetic retinopathy)?
Performance metrics: What metrics are used to measure the AI's accuracy (e.g., sensitivity, specificity, AUC, FROC, precision, recall)?
Ground truth derivation: How was the definitive diagnosis for the test cases established (e.g., biopsy, follow-up, expert consensus with adjudication)?
Study design for AI performance: Details of an MRMC study, standalone performance study, etc.

Since none of this is present, I cannot fill out the requested table or answer the specific questions about AI/CADe device performance directly from this document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

February 8, 2017

Vieworks Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 800 Roosevelt Suite 417 IRVINE CA 92620

Re: K163703

Trade/Device Name: VIVIX-S 1417N Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: January 5, 2017 Received: January 9, 2017

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. 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.

Michael D'Hara

For 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)

K163703

Device Name VIVIX-S 1417N

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

[As required by 21 CFR 807.92]

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

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

02/06/2017

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

Name of Sponsor:	Vieworks Co., Ltd.
Address:	(Gwanyang-dong) 41-3, Burim-ro 170beon-gil, Dongan-guAnyang-si, Gyeonggi-do, 431-060 Republic of Korea
Contact Name:	Kim, Jordin / Regulatory AffairsAssociate
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 1417N
Model Name:	FXRD-1417NAWFXRD-1417NBW
Common Name:	Digital Flat Panel X-ray Detector
Classification Name:	Stationary x-ray system
Classification Panel:	Radiology
Classification Regulation:	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:	K152894
Product Code:	MQB
Classification Name:	Stationary x-ray system
Classification Regulation:	21 CFR 892.1680
Applicant:	Vieworks Co., Ltd.
Trade Name:	VIVIX-S 1717N
Model Name:	FXRD-1717NAFXRD-1717NBFXRD-1717NAWFXRD-1717NBW
Decision Date:	02/26/2016
Type:	Traditional

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

General Description o

These devices should be integrated with an operating PC and an X-Ray generator to digitalize Xray images and transfer the digitalized images for radiography diagnostic.

Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, andimage information sharing on the network.

Differences between models O

Models FXRD-1417NAW and FXRD-1417NBW are digital X-ray flat panel detectors, and each model has a 14 x 17 inch imaging area.

Both FXRD-1417NAW and FXRD-1417NBW communicate by using a wireless communication feature (IEEE 602.Ila/b/g/n).

The scintillator used in FXRD-1417NAW is Csl andGadox was used for FXRD-1417NBW.

Mode	Description
AED	The detector detects X-ray exposure from the generator automatically and then performs image acquisition without any cable connection.
DR Trigger	The detector and generator receive and send their signal to each other for image acquisition. SCU and X-ray generator should be connected with the generator interface cable.

Device Integration21 CFR 1020.30 (a) (1)(ii) O

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

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

Comparisons with the predicate, devices show the technological characteristics of the proposed FXRD-1417NAW and FXRD-1417NBW devices 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 (K152894), the FXRD-1417NAW and FXRD-1417NBW 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)

There are no significant difference between the FXRD-1717NAW and FXRD-1717NBW and the predicate device that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use.

Parameter	Predicate Devices	Subject Device
510(k) Number	K152894	K163703
Manufacturer	Vieworks Co., Ltd.
Model Name	FXRD-1717NA,FXRD-1717NB,FXRD-1717NAW,FXRD-1717NBW	FXRD-1417NAW,FXRD-1417NBW
Common Name	Digital Flat Panel X-ray Detector
Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)

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Classification Panel	Radiology
Classification Regulation	21 CFR 892.1680
Product Code	MQB
Device Class	2
Intended Use	FXRD-1717NA, FXRD-1717NB,FXRD-1717NAW and FXRD-1717NBW are indicated fordigital imaging solution designedas a general radiographic systemfor human anatomy. It isintended to replace film orscreen based radiographicsystems in all general purposesof diagnostic procedures. It isnot to be used formammography.	FXRD-1417NAW and FXRD-1417NBW are indicated fordigital imaging solution designedas a general radiographic systemfor human anatomy. It isintended to replace film orscreen based radiographicsystems in all general purposesof diagnostic procedures. It is notto be used for mammography.
Design	Panel Shape	Square Panel	Square Panel
	Field of View	17 x 17inch	14 x 17inch
	Dimensions(H x W x D)	460.0 x 460.0 x 15.5mm	384mm x 460mm x 15.0mm
	Pixel Pitch	0.14mm	0.14mm
	Materials Scintillator	Csl: TI,Gd2O2S:Tb	Csl: TI,Gd2O2S:Tb
DataTransmission	Wired	Max. 1Gbps	Max. 1Gbps
	Wireless	• IEEE802.11n: Max. 300Mbps(MIMO 2X2)	• IEEE802.11n: Max. 450Mbps(MIMO 3X3)• IEEE802.11ac: Max.1300Mbps (MIMO 3X3)
	Communication Method	Wired onlyWireless & Wired	Wireless & Wired
Performance	DQE	FXRD-1717NAW:min. 47 (typ.50)FXRD-1717NBW:min. 25 typ.(27)	FXRD-1417NAW:min. 47 (typ.50)FXRD-1417NBW:min. 25 typ.(27)
	MTF	FXRD-1717NAW:min. 68 (typ. 72)FXRD-1717NBW:min. 58 (typ. 60)	FXRD-1417NAW:min. 68 (typ. 72)FXRD-1417NBW:min. 58 (typ. 60)
	Resolution	3.5 lp/mm	3.5 lp/mm
	Sensitivitylinearity	FXRD-1717NAW:LinearFXRD-1717NBW:Linear	FXRD-1417NAW:LinearFXRD-1417NBW:Linear
	NPS	FXRD-1717NAW:0.9FXRD-1717NBW:	FXRD-1417NAW:0.9FXRD-1417NBW:
	1.09	1.09
SpatialResolution	FXRD-1717NAW:4.1-4.3	FXRD-1417NAW:4.1-4.3
	FXRD-1717NBW:3.8-4.1	FXRD-1417NBW:3.8-4.1
MinimumDose	FXRD-1717NAW:0.2 uGy (2.5-2.8 cycles/mm )	FXRD-1417NAW:0.2 uGy (2.5-2.8 cycles/mm )
	FXRD-1717NBW:0.3 uGy(2.5-2.8 cycles/mm)	FXRD-1417NBW:0.3 uGy(2.5-2.8 cycles/mm)
Lag	FXRD-1717NAW:Non	FXRD-1417NAW:Non
	FXRD-1717NBW:Non	FXRD-1417NBW:Non
QuantumLimitedPerformance	FXRD-1717NAW:0.004 (mR)	FXRD-1417NAW:0.004 (mR)
	FXRD-1717NBW:0.008(mR)	FXRD-1417NBW:0.008(mR)
ImageAcquisition	2.0-2.5 sec	2.0-2.5 sec
Black Level	800-1,600	800-1,600

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9. Summary of Non-Clinical Data

A comparison test was conducted between the subject devices (FXRD-1417NAW and FXRD-1417NBW) and the predicate device (K152894) on the items such as DQE, MTF and spatial resolution.

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

[IEC 60601-1 2005, Edition 3.1]	Medical Electrical Equipment -- Part 1: GeneralRequirements For Basic Safety And Essential Performance
[IEC 60601-1-2, Edition 3]	Medical Electrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Compatibility -Requirements And Tests
[IEC 62220-1, Edition 1.0]	Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detectivequantum efficiency
[NEMA PS 3.1 - 3.20 2011]	Digital Imaging and Communications in Medicine (DICOM)Set

[IEC 62133, Edition 2.0] IEC 62133 Edition 2.0 2012-12 Secondary Cells And Batteries Containing Alkaline Or Or Other Non-Acid Electrolytes•Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications [Including: Corrigendum 1 (2013)

Test Item	Type	Subject Device	Predicate Device
Sensitivitylinearity	Csl	Linear	Linear
	Gadox	Linear	Linear
MTF	Csl	min. 68 (typ. 72)	min. 68 (typ. 72)
	Gadox	min. 58 (typ. 60)	min. 58 (typ. 60)
DQE	Csl	min. 47 (typ.50)	min. 47 (typ.50)
	Gadox	min. 25 typ.(27)	min. 25 typ.(27)
NPS	Csl	0.9	0.96
	Gadox	1.09	1.165
SpatialResolution	Csl	4.1-4.3	4.3-4.5
	Gadox	3.8-4.1	4.3-4.5
MinimumDose	Csl	0.2 uGy (2.5-2.8 cycles/mm)	0.2 uGy (2.5-2.8 cycles/mm )
	Gadox	0.3 uGy(2.5-2.8 cycles/mm)	0.3 uGy(2.5-2.8 cycles/mm)
Lag	Csl	None	None
	Gadox	None	None

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QuantumLimitedPerformance	CsI	0.004 (mR)	0.008 (mR)
	Gadox	0.008(mR)	0.014 (mR)
ImageAcquisition	-	2.0-2.5 sec	2.0-2.5 sec
Black Level	-	800-1,600	1,400-1,500

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 FXRD-1417NAW and FXRD-1417NBW provide images of equivalent diagnostic capability to the predicate devices, the VIVIX-S 1717N, and its results demonstrate substantial equivalence.

Clinical images were provided; these images were not necessary to establish substantial equivalence based on the differences from the predicate but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.

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

The FXRD-1417NAW and FXRD-1417NBW Digital X-ray detectors are substantially equivalent to the currently marketed and predicate devices(K152894) 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, IEC60601-1-2, IEC62220-1 and NEMA PS 3.1 - 3.20, IEC 62133 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 X-ray Imaging Devices.

The results of these tests demonstrate that FXRD-1417NAW and FXRD-1417NBW Digital X-ray detectors meet the acceptance criteria and are 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.

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.