ViVIX-S is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography and/or for fluoroscopy.

Device Description

ViVIX-S is a digital X-ray flat panel detector which has 43x43cm (FXRD-1717SA, FXRD-1717SB) or 35.8x43cm (FXRD-1417SA, FXRD-1417SB) imaging area. The device intercepts 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, it is converted to digital value, and the images will be displayed on monitors.

This device should be integrated with an operating PC and an X-Ray generator. It can do to utilize as digitalizing x-ray images and transfer for radiography diagnostic. Advanced digital imaging process allows considerably efficient diagnosis, all kind of information management, sharing of image information on network.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the ViVIX-S device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The document describes both non-clinical and clinical studies conducted to demonstrate substantial equivalence to predicate devices. The acceptance criteria are implicitly met by showing "no significant differences" in the clinical study and "satisfactory" results and "substantially equivalent" characteristics in the non-clinical studies.

Acceptance Criteria Category	Reported Device Performance (ViVIX-S)
Non-clinical Performance
Detective Quantum Efficiency (DQE)	Substantially equivalent to predicate device
Quantum Limited Performance	Substantially equivalent to predicate device
Modulation Transfer Function (MTF)	Substantially equivalent to predicate device
Effects of Aliasing	Substantially equivalent to predicate device
Sensitivity Linearity	Substantially equivalent to predicate device
Lag (Erasure Thoroughness)	Substantially equivalent to predicate device
Change in Detection Sensitivity	Substantially equivalent to predicate device
Dose Requirement & Reciprocity	Substantially equivalent to predicate device
Stability of Device Characteristics with Time	Substantially equivalent to predicate device
Uniformity of Device Characteristic	Substantially equivalent to predicate device
Noise Power Spectrum (NPS)	Substantially equivalent to predicate device
Spatial Resolution	Substantially equivalent to predicate device
Minimum Dose	Substantially equivalent to predicate device
Image Acquisition Time	Substantially equivalent to predicate device
Black Level	Substantially equivalent to predicate device
Clinical Performance
Image Concurrence Study	No significant differences compared to predicate device images
Electrical Safety & EMC
IEC 60601-1 (Electrical Safety)	All test results were satisfactory
IEC 60601-1-2 (EMC Testing)	All test results were satisfactory

Study Details

Here's the detailed information about the studies conducted:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: 30 clinical images.
- Data Provenance: Not explicitly stated, but given the manufacturer is based in South Korea, it is likely the data was collected there. The study is described as a "concurrence study," which often implies prospective collection for the purpose of the study, though it's not explicitly stated as retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts used or their qualifications for the clinical image concurrence study. It only states a "concurrence study of 30 clinical images was conducted to compare the performance of the ViVIX-S to the predicate device."
Adjudication method for the test set:
- The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the clinical image concurrence study. It implies a comparison without detailing the consensus process.
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, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not done. This study solely compared the image quality of the new device to a predicate device. The device is a "Digital Flat Panel X-ray Detector," not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The clinical study was a "concurrence study" of images. While not explicitly stated as "standalone algorithm performance," the nature of comparing image quality to a predicate device implies an assessment of the device's output (the image) rather than a human reading process. The non-clinical studies (DQE, MTF, NPS, etc.) are inherently standalone assessments of the device's physical performance characteristics.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical study, the "ground truth" was implicitly established by the images from the predicate device (K090742) being the standard against which the ViVIX-S images were compared. The statement "There were no significant differences between the images of the ViVIX-S and the predicate device images" indicates the predicate device's image quality was the benchmark. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for diagnostic accuracy.
The sample size for the training set:
- The document does not mention a training set or any machine learning/AI components that would require one. The ViVIX-S is a hardware device (a digital X-ray detector).
How the ground truth for the training set was established:
- As there is no mention of a training set, the establishment of ground truth for a training set is not applicable.

Summary

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510(k) Summary (K120020)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: May 2, 2011

Company and Correspondent making the submission:

Name - Vieworks Co., Ltd.

Address – #604, Suntechcity 2, 307-2, Sangdaewon-dong, Jungwon-gu, Seongnam-city, Gyeonggi-do, 462-806 South Korea .

Telephone -- +82-70-7011-6176

Fax - +82-31-737-4953

Contact - Ms. JungMi Kim / Compliance Officer

Internet – http://www.vieworks.com

Proposed Device :

Trade/	Proprietary	Name	: ViVIX-
		Shttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?start_search=1&ProductCode=MLR
Common Name		: Digital Flat Panel X-ray Detector
Classification Name		: Solid State X-ray Imager
Product Code		: MOB

Device Class	: 2
Regulation Number	: 892.1650

Predicate Device :

Manufacturer	: VARIAN Medical Systems Inc.
Trade/ Proprietary Name	: Paxscan 4030 Medical Digital Imaging System
Common Name	: Flat Panel Digital Imager
Classification Name	: Solid State X-ray Imager
Product Code	: MQB

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Device Class	: 2
510(k) Number	: K024147
Manufacturer	: Samsung Mobile Display Co., Ltd.
Trade/ Proprietary Name	: LTX-240AA01-A
Common Name	: Digital Plate Panel X-ray Detector
Classification Name	: Solid State X-ray Imager
Product Code	: MQB
Device Class	: 2
510(k) Number	: K090742

Description :

Intended use :

Comparison with predicate device:

The imaging principle, intended use, technology and materials of ViVIX-S are substantially equivalent to the predicated devices, Paxscan 4030R of VARIAN Medical Systems Inc. and LTX240AA01-A of Samsung Mobile Display Co., Ltd. for the specified indications and satisfy the FDA regulatory requirements for a 510(k).

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Safety, EMC and Performance Data :

· Electricl safety and EMC testing

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. All test results were satisfactory.

■ Non-clinical study

The following non-clinical studies have been performed and the results show that the ViVIX-S is substantially equivalent to the predicate devices in these characteristics.

Detective quantum efficiency(DQE), Quantum limited performance, Modulation transfer function(MTF), Effects of aliasing, Sensitivity linearity, Lag(Erasure thoroughness), Change in detection sensitivity, Dose requirement and reciprocity changes, Stability of device characteristics with time, Uniformity of device characteristic, Noise power spectrum(NPS), Spatial resolution, Minimum dose, Image Acquisition time, & Black level
· Clinical study
A concurrence study of 30 clinical images was conducted to compare the performance of the ViVIX-S to the predicate device (K090742). There were no significant differences between the images of the ViVIX-S and the predicate device images.

Conclusions :

Based on the results of the non-clinical and the clinical studies performed, we conclude that the ViVIX-S is effective, and substantially equivalent to the predicate devices.

END

Vieworks Co., Ltd.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

MAY - 4 2012

Vieworks Co., Ltd. Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 951 Starbuck Street, Unit J FULLERTON CA 92833

Re: K120020

Trade/Device Name: ViVIX-S Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: April 24, 2012 Received: April 26, 2012

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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.fdaggov/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 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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K120020

Device Name: ViVIX-S

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

MhD'O'M

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number Klaaaaaa

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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.