ViVIX-S wireless 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

The ViVIX-S Wireless is a digital X-ray flat panel detector which has 35.8cm x 43cm (FXRD-1417WA, FXRD-1417WB) imaging area and communicates via not only the wireless communication feature (IEEE 802.11a/b/g/n) but also wired communication feature (Giga-bit Ethernet communication method by connecting to a tether cable) optionally. 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 a digital value, and an image will be displayed on the monitor. This device should be integrated with an operating PC and an X-Ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic.

AI/ML Overview

Here's an analysis of the provided text to extract information about acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria or a specific table for them in the traditional sense of performance metrics with thresholds. However, it implicitly uses a "substantial equivalence" framework. The performance data presented focuses on comparing the new device, ViVIX-S Wireless, to a predicate device, ViVIX-S.

Acceptance Criteria Category (Implicit)	Reported Device Performance
Non-clinical equivalence	- Detective Quantum Efficiency (DQE): No significant difference reported when compared to predicate.- Quantum limited performance: No significant difference reported.- Modulation Transfer Function (MTF): No significant difference reported.- Effects of aliasing: No significant difference reported.- Sensitivity linearity: No significant difference reported.- Lag (Erasure thoroughness): No significant difference reported.- Change in detection sensitivity: No significant difference reported.- Dose requirement and reciprocity changes: No significant difference reported.- Stability of device characteristics with time: No significant difference reported.- Uniformity of device characteristic: No significant difference reported.- Noise power spectrum (NPS): No significant difference reported.- Spatial resolution: No significant difference reported.- Minimum dose: No significant difference reported.- Image Acquisition time: No significant difference reported.- Black level: No significant difference reported.
Clinical equivalence	- Comparison of Clinical Images: "No significant difference between the images of the ViVIX-S Wireless and those of the predicate device."
Safety and EMC (Implicit)	- Electrical safety and EMC testing: "All test results were satisfactory" according to IEC 60601-1 and IEC 60601-1-2.

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

Sample Size for Test Set: 30 clinical images were used for the clinical study.
Data Provenance: Not explicitly stated, but the company is based in South Korea. The study compares the new device to a predicate device, implying these images likely originated from a clinical setting where both devices could be used, or the predicate device was the source. This would likely be retrospective as it compares existing images or recent acquisitions for the purpose of demonstrating equivalence, rather than a planned prospective study where specific patient cohorts are followed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts or their qualifications for establishing ground truth in either the non-clinical or clinical studies. The clinical study states a "concurrence study" was done, implying expert review, but details are absent.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The term "concurrence study" suggests some form of agreement or comparison, but the methodology for resolving discrepancies or establishing the "true" finding is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The document describes a "concurrence study of 30 clinical images" to compare performance. While clinical images were used and a comparison was made, it does not explicitly describe an MRMC comparative effectiveness study with human readers improving with AI vs. without AI assistance. This device is an X-ray detector, not an AI diagnostic algorithm. The study's aim was device equivalence, not reader performance with AI. Therefore, no effect size for human reader improvement with AI is provided.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Yes, the "non-clinical study" can be considered a standalone performance evaluation of the device's technical specifications. It assessed intrinsic image quality metrics like DQE, MTF, NPS, spatial resolution, etc., independent of human interpretation for diagnostic tasks.

7. The Type of Ground Truth Used

Non-clinical study: The "ground truth" for the non-clinical studies was based on objective, quantifiable physical and technical performance metrics of the X-ray detector itself (e.g., measured DQE, MTF, NPS, etc.) compared to established benchmarks or the predicate device's measured performance.
Clinical study: For the clinical images, the "ground truth" or reference standard for comparison was the images from the predicate device. The study aimed to show "no significant difference" between images produced by the new device and the predicate device. This implies that the image quality and diagnostic information contained within the predicate device's images served as the de facto reference. The document does not mention pathology, outcomes data, or a separate expert consensus establishing specific diagnoses as ground truth for these 30 images, but rather the quality and equivalence of the images themselves.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The ViVIX-S Wireless is a digital X-ray detector, a hardware device, not an AI algorithm that requires a training set of data.

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

This information is not applicable and not provided, as the device is a hardware component and not an AI algorithm requiring a training set.

Summary

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510(k) Summary

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

Date: JAN. 7, 2013_

Company and Correspondent Making the Submission:

Name - Vieworks Co., Ltd.

Address - #107~~108, 601~~610 Suntechcity II, 52 Sagimakgol-ro, Jungwon-gu Seongnam-si, Gyeonggi-do

462-736, South Korea

Telephone - +82-70-7011-6176

Fax - +82-31-737-4953

Contact - Ms. Sungwhie Kim

Official website - http://www.vieworks.com

Proposed Device:

Trade/ Proprietary Name	: VIVIX-S Wireless
Common Name	: Digital Flat Panel X-ray Detector
Classification Name	: Solid State X-ray Imager
Product Code	: MQB
Device Class	: 2
Regulation Number	: 892.1650

Predicate Device:

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Description:

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 a digital value, and an image will be displayed on the monitor.

This device should be integrated with an operating PC and an X-Ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic.

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

Intended use:

The ViVIX-S Wireless is 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.

Comparison with Predicate Device:

The predicate device (ViVIX-S) and candidate device (ViVIX-S Wireless) share most of primary product specifications including intended use, technology, material, and imaging principle, etc. Difference lies in the means of connectivity. While predicate device provides only a wired connection between the detector and System Control Unit (SCU), the candidate device supports both wired and wireless connections. The wireless functions that are newly added to the candidate device aim to promote less restricted use of the imaging system. Beside the connection methods, there are also several differences of minor significance. For example, the candidate device is offered only in 14" x 17" while the predicate device comes in 17" x 17" and 14" x 17".

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Safety, EMC and Performance Data:

· Electrical safety and EMC testing

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

■ Non-clinical study

The following non-clinical studies have been performed and the results have shown that the ViVIX-S Wireless is substantially equivalent to the predicate devices on the Market (ViVIX-S).

-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 Wireless to that of the predicate device (K120020). There was no significant difference between the images of the ViVIX-S Wireless and those of the predicate device.

Conclusions:

Based on the robust set of results from the non-clinical and clinical studies that have been performed, the ViVIX-S Wireless has been found to be substantially equivalent to the predicate device as well as found to be a safe and effective X-ray imaging system.

END

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 emblem featuring a symbol with three curved shapes.

Public Health Service

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

February 1, 2013

Vieworks Co., Ltd C/O Pricilla Chung Official Correspondent LK Consulting Group USA, Inc. 951 Starbuck St., Unit J FULLERTON CA 92833

Re: K122865

Trade/Device Name: ViVIX-S Wireless Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: January 8, 2013 Received: January 15, 2013

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sean M. Boyd -S

for

Janine M. Morris 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): K122865

Device Name: ViVIX-S Wireless

Indications for Use:

Prescription Use X (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 Diagnostics and Radiological Health (OIR)

Sean M. Boyd -S

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) K122865

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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.