ViVIX-S with VXvue 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 with VXvue 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 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, and sharing of image information on network.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Metric	Predicate Device (K120020)	Proposed Device (ViVIX-S with VXvue)	Acceptance Status
Non-Clinical Performance	Detective quantum efficiency (DQE)	Not explicitly stated	Performed	Satisfactory (Substantially Equivalent)
	Quantum limited performance	Not explicitly stated	Performed	Satisfactory (Substantially Equivalent)
	Modulation transfer function (MTF)	Not explicitly stated	Performed	Satisfactory (Substantially Equivalent)
	Effects of aliasing	Not explicitly stated	Performed	Satisfactory (Substantially Equivalent)
	Sensitivity linearity	Not explicitly stated	Performed	Satisfactory (Substantially Equivalent)
	Lag (Erasure thoroughness)	Not explicitly stated	Performed	Satisfactory (Substantially Equivalent)
	Change in detection sensitivity	Not explicitly stated	Performed	Satisfactory (Substantially Equivalent)
	Dose requirement and reciprocity changes	Not explicitly stated	Performed	Satisfactory (Substantially Equivalent)
	Stability of device characteristics with time	Not explicitly stated	Performed	Satisfactory (Substantially Equivalent)
	Uniformity of device characteristic	Not explicitly stated	Performed	Satisfactory (Substantially Equivalent)
	Noise power spectrum (NPS)	Not explicitly stated	Performed	Satisfactory (Substantially Equivalent)
	Spatial resolution	Not explicitly stated	Performed	Satisfactory (Substantially Equivalent)
	Minimum dose	Not explicitly stated	Performed	Satisfactory (Substantially Equivalent)
	Image Acquisition time	Not explicitly stated	Performed	Satisfactory (Substantially Equivalent)
	Black level	Not explicitly stated	Performed	Satisfactory (Substantially Equivalent)
Clinical Performance	Concurrence Study (Image Comparison)	K120020	ViVIX-S with VXvue	No significant differences found
Safety and EMC	Electrical safety (IEC 60601-1)	Not explicitly stated	Performed	Satisfactory
	EMC (IEC 60601-1-2)	Not explicitly stated	Performed	Satisfactory

Note: The document states that the non-clinical and clinical studies "show that the ViVIX-S with VXvue is substantially equivalent to the predicate devices in the market." For the clinical study, it specifically notes "no significant differences between the images." This implies the acceptance criteria for these metrics were met by demonstrating equivalence or lack of significant difference compared to the predicate. The specific numerical thresholds for "acceptance criteria" are not provided in this document.

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

Sample Size (Test Set): 30 clinical images.
Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective. It is implied to be clinical data used for comparison.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document only mentions a "concurrence study" comparing images, but does not detail the methodology for establishing ground truth or who performed the comparison.

4. Adjudication Method for the Test Set

Not specified. The document simply states "A concurrence study of 30 clinical images was conducted to compare the performance... There were no significant differences." It doesn't describe the adjudication process if multiple reviewers were involved or how disagreements were resolved.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly stated or described. The clinical study was a concurrence study comparing images from the new device to the predicate, not an assessment of human reader performance with or without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.

While the device itself is a digital X-ray flat panel detector (hardware), and the "VXvue" part is advanced digital imaging process, the study described is a comparison of images produced by the device against a predicate, not an "algorithm-only" performance evaluation in the context of AI. The "advanced digital imaging process" implies software components, but its standalone diagnostic performance is not detailed separately from the hardware's image acquisition.

7. The type of ground truth used

The implicit "ground truth" for the clinical study was the image quality and diagnostic information provided by the predicate device (K120020). The study aimed to show "no significant differences" between the images of the proposed device and those of the legally marketed predicate. It's a comparison to an established device, rather than an independent expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable/Not specified. This device is a digital X-ray detector, not an AI/ML algorithm that requires a training set in the conventional sense. The "advanced digital imaging process" is mentioned, but there is no indication of a machine learning component requiring a distinct training set. The study focuses on the performance of the imaging hardware and its processing in comparison to the predicate.

9. How the ground truth for the training set was established.

Not applicable/Not specified, as no training set for an AI/ML algorithm is described in this submission.

Summary

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K 12 28 bb

510(k) Summary

JAN 1 1 2013

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

Date: SEP. 11, 2012_

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. Sungwhie Kim

Internet – http://www.vieworks.com

Proposed Device :

Trade/ Proprietary Name	: VIVIX-S with VXvue
Classification Name	: Solid State X-ray Image
Product Code	: MQB
Device Class	: 2
Regulation Number	: 892.1680

Predicate Device :

Manufacturer	: Vieworks Co., Ltd.
Trade/ Proprietary Name	: VIVIX-S
Classification Name	: Solid State X-ray Imager
Product Code	: MQB
Device Class	: 2
510(k) Number	: K120020

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Description:

ViVIX-S with VXvue 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 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, and sharing of image information on network.

Intended use:

Comparison with predicate device:

The imaging principle, intended use, technology and materials of ViVIX-S with VXvue are substantially equivalent to the predicate device, ViVIX-S of Vieworks Co., Ltd. for the specified indications and satisfy the FDA regulatory requirements for a 510(k).

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 with VXvue is substantially equivalent to the predicate devices in the

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market.

-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 with VXvue to the predicate device (K120020). There were no significant differences between the images of the ViVIX-S with VXvue and the predicate device images.

Conclusions :

Based on the result of the non-clinical and the clinical study performed, we conclude that the ViVIX-S with VXvue is safe, effective, and substantially equivalent to the predicate devices.

END

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract eagle or bird-like figure, composed of three curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

January 11, 2013

Vieworks Co., Ltd. C/O Ms. Priscilla Chung Regulatory Affairs Consultant 951 Starbuck St. Unit J FULLERTON CA 04300

Re: K122866

Trade/Device Name: ViVIX-S with VXvue Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: November 26, 2012 Received: November 29, 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. 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), 1 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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Page 2-Ms. Chung

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 MBoyd -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): K122866

Device Name: ViVIX-S with VXvue

Indications for Use:

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

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

(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

K122866 510(k)

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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.