VIVIX-S 1717V series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film/ screen systems. The VIVIX-S 1717V series is not intended for mammography applications.

Device Description

VIVIX-S 1717V - Models FXRD-1717VA and FXRD-1717VB 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, and image information sharing on the network.

VIVIX-S 1717V - Models FXRD-1717VA and FXRD-1717VB are digital X-ray flat panel detectors, and each model has a 17 x 17 inch imaging area.

The scintillator used in FXRD-1717VA is Csl and Gadox was used for FXRD-1717VB.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided document:

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" in a separate, defined table with specific metrics that needed to be met to demonstrate equivalence. Instead, it relies on demonstrating substantial equivalence to a predicate device (VIVIX-S 1717N, K152894) through a comparison of technological characteristics and performance metrics, primarily DQE and MTF. The underlying acceptance criterion for these performance metrics is that they are "similar" to or within an acceptable range of the predicate device's performance.

Implicit Acceptance Criteria and Reported Device Performance:

Parameter	Predicate Device (VIVIX-S 1717N) Performance	Subject Device (VIVIX-S 1717V) Performance	Acceptance Criteria (Implicit)
DQE (%) (1lp/mm)	FXRD-1717NAW: 54FXRD-1717NBW: 31	FXRD-1717VA: 53.5FXRD-1717VB: 29	Performance to be "similar" to the predicate device, indicating equivalent diagnostic capability. The reported values are very close.
MTF (%) (1lp/mm)	FXRD-1717NAW: 72FXRD-1717NBW: 58	FXRD-1717VA: 66.5FXRD-1717VB: 58	Performance to be "similar" to the predicate device, indicating equivalent diagnostic capability. The reported values are very close.
Resolution	3.5 lp/mm	3.5 lp/mm	Identical to the predicate device.
Indications for Use	General-purpose diagnostic procedures (not mammography)	General-purpose diagnostic procedures (not mammography)	Identical to the predicate device.
Design/Technological Characteristics	Square Panel, 17x17inch Field of View, 0.14mm Pixel Pitch, Csl:TI / Gd2O2S:Tb Scintillator, Wired/Wireless Communication	Square Panel, 17x17inch Field of View, 0.14mm Pixel Pitch, Csl:TI / Gd2O2S:Tb Scintillator, Wired Communication (for subject device)	Substantially equivalent (e.g., similar or identical) characteristics to the predicate device.

The document concludes that "The results of these tests demonstrate that VIVIX-S 1717V - FXRD-1717VA and FXRD-1717VB Digital X-ray detectors meets the acceptance criteria and is adequate for this intended use."

Study Details

The primary study mentioned is a single-blinded concurrence study and a comparison test of non-clinical data.

Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for the clinical concurrence study. The document mentions "clinical images were provided," but doesn't quantify them. For the non-clinical data (DQE, MTF, spatial resolution), standard phantom images are typically used, but the quantity is not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It's likely prospective data gathered for the submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The term "ground truth" is not used in the context of the clinical study; rather, it refers to a "concurrence study," implying comparison of image interpretations.
Adjudication method for the test set:
- Not explicitly stated. A "single-blinded concurrence study" suggests that readers were unaware of which device generated the image, and their interpretations were compared. However, the method for resolving discrepancies or establishing an ultimate "truth" for evaluation is not detailed.
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, an MRMC comparative effectiveness study was not done in the context of evaluating AI assistance. This study aims to demonstrate substantial equivalence between two X-ray detectors (subject device vs. predicate device), not the impact of AI on human reader performance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this device is an X-ray detector, not an AI algorithm. Therefore, a standalone performance evaluation of an algorithm is not applicable. The device's performance is assessed through image quality metrics (DQE, MTF, resolution) and a clinical concurrence study with human readers.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies expert consensus/interpretation for the clinical concurrence study ("provide images of equivalent diagnostic capability"). For the non-clinical performance data (DQE, MTF, Resolution), the "ground truth" is established by physical measurements and adherence to international standards (IEC 62220-1).
The sample size for the training set:
- This device is an X-ray detector, not an AI or machine learning algorithm that requires a "training set." Therefore, this question is not applicable to the information provided.
How the ground truth for the training set was established:
- As this device does not involve an AI algorithm with a training set, this question is not applicable.

Summary

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May 15, 2018

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Vieworks Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 690 Roosevelt IRVINE CA 92620

Re: K181003

Trade/Device Name: VIVIX-S 1717V Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: March 29, 2018 Received: April 16, 2018

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 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);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Hsl 2 Nils

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)

K181003

Device Name

VIVIX-S 1717V

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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510(k) Summary

[As required by 21 CFR 807.92] (K181003)

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

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

05/11/2018

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-gu, 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 1717V
Model Name:	FXRD-1717VAFXRD-1717VB
Common Name:	Digital Flat Panel X-ray Detector
Classification Name:	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Classification Panel:	Radiology
Classification Regulation:	21 CFR 892.1680
Regulation Name:	Stationary X-ray System
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
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
VIVIX-S 1717V - Models FXRD-1717VA and FXRD-1717VB 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, and image information sharing on the network.

O Differences between models
VIVIX-S 1717V - Models FXRD-1717VA and FXRD-1717VB are digital X-ray flat panel detectors, and each model has a 17 x 17 inch imaging area.

The scintillator used in FXRD-1717VA is Csl and Gadox was used for FXRD-1717VB.

6. Indications for 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 VIVIX-S 1717V - FXRD-1717VA and FXRD-1717VB devices to be substantially equivalent to the predicate devices. The proposed devices are functionally similar 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-1717VA and FXRD-1717VB presented in this submission has the same:

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

There is similar performance as follow.

Performance (MTF)
Performance (DQE)

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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
Manufacturer	Vieworks Co., Ltd.
Model Name	FXRD-1717NA,FXRD-1717NB,FXRD-1717NAW,FXRD-1717NBW	FXRD-1717VA,FXRD-1717VB
Common Name	Digital Flat Panel X-ray Detector
Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Classification Panel	Radiology
Classification Regulation	21 CFR 892.1680
Product Code		MQB
Device Class		2
Indications for 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 purposes ofdiagnostic procedures. It is not tobe used for mammography.	VIVIX-S 1717V series is used forthe general-purpose diagnosticprocedures, and as well asintended to replace radiographicfilm/ screen systems. The VIVIX-S1717V series is not intended formammography applications.
Design
Panel Shape	Square Panel	Square Panel
Field of View	17 x 17inch	17 x 17inch
Dimensions(H x W x D)	460.0 x 460.0 x 15.5mm	460.0 x 460.0 x 15.5mm
Pixel Pitch	0.14mm	0.14mm
Materials Scintillator	Csl: TI,Gd2O2S:Tb	Csl: TI,Gd2O2S:Tb
Performance
DQE (%) (1lp/mm)	FXRD-1717NAW:54FXRD-1717NBW:31	FXRD-1717VA:53.5FXRD-1717VB:29
MTF (%) (1lp/mm)	FXRD-1717NAW:72FXRD-1717NBW:58	FXRD-1717VA:66.5FXRD-1717VB:58
Resolution	3.5 lp/mm	3.5 lp/mm
Communication Method	Wired(FXRD-1717NA,FXRD-1717NB),Wireless(FXRD-1717NAW,FXRD-1717NBW)	Wired

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9. Summary of Non-Clinical Data

A comparison test was conducted between the subject devices 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][IEC 60601-1-2, Edition 3]	Medical Electrical Equipment -- Part 1: GeneralRequirements For Basic Safety And Essential PerformanceMedical 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 thedetective quantum 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 AndBatteries Containing Alkaline Or Other Non-AcidElectrolytes• Safety Requirements For Portable SealedSecondary Cells, And For Batteries Made From Them, ForUse In Portable Applications [Including: Corrigendum 1(2013)

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

Although clinical images were provided, they are not necessary to establish substantial equivalence based on the modifications to the device (note X-ray digital detector that is based on the predicate technology) but they provide further evidence in addition to the laboratory performance data to show that the subject device works as intended.

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

The VIVIX-S 1717V - FXRD-1717VA and FXRD-1717VB 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, IEC 60601-1-2, 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 VIVIX-S 1717V - FXRD-1717VA and FXRD-1717VB 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.

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.