Xmaru View V1(Xmaru Chiroview or Xmaru Podview) software carries out the image processing and administration of medical X-ray data which includes adjustment of window leveling, rotation, zoom, and measurements. Xmaru View V 1(Xmaru Chiroview or Xmaru Podview) is not approved for mammography and is meant to be used by qualified medical personnel only. Xmaru Chiroview or Xmaru Podview) is complying with DICOM standards to assure optimum communications between network systems.

Xmaru PACS receives, stores, searches and views the diagnostic image data from imaging modalities in DICOM compliant. Xmaru PACS is capable of communicating with electronic medical records systems, hospital information systems, and radiology information system via DICOM standard.

Xmaru View V1(Xmaru Chiroview or Xmaru Podview) and Xmaru PACS can be packaged together or offered as a standalone imaging solution to be installed in a PC for trained medical professionals.

Device Description

XmaruView V1(Xmaru Chiroview or Xmaru Podview) is a software program designed to provide image acquisition, processing and operational management functions for digital radiography.

XmaruView V1(Xmaru Chiroview or Xmaru Podview) controls a flat-panel detector and a X-ray generator to acquire digital images. The software also manages patient information, capture and store diagnostic images in an internal database. It also supports DICOM which allows compatibility with other radiography equipment and network programs. XmaruView V1(Xmaru Chiroview or Xmaru Podview) provides a streamlined and optimized process of multiple workflows in any hospital environment for digital radiography.

Xmaru PACS is in charge of receiving the images from multiple modalities and storing data in the server. This software manages, searches and viewes the stored images in the server. Xmaru PACS is capable of communicating with electronic medical records systems, hospital information systems, and radiology information system via DICOM standard.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical image processing software (Xmaru View V1, Xmaru Chiroview, Xmaru Podview, and Xmaru PACS). However, it does not contain the detailed information required to answer many of the specific questions about acceptance criteria and the study that proves the device meets them, especially regarding AI/algorithm performance, ground truth establishment, or multi-reader studies.

The document primarily focuses on establishing substantial equivalence to a predicate device (VATECH Co.,Ltd. XmaruView V1, K102078) based on functional similarities and software validation. It mentions general software validation, risk analysis, and functional tests but lacks specific performance metrics or clinical study details.

Based only on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document states: "The validation testing verified and validated the risk analysis and individual performance results were within the predetermined acceptance criteria." However, it does not provide a table of specific acceptance criteria or the reported numeric performance of the device against those criteria. It implies that performance was assessed against functional requirements and risk mitigation, but no quantifiable metrics are given.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "The complete system configuration has been assessed and tested by the manufacturer and passed all in-house testing criteria." This refers to nonclinical testing and software validation. No information about a "test set" in the context of clinical images, sample size, data provenance (country of origin), or retrospective/prospective nature is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable/Not provided. The document describes software for image processing and PACS functionalities, not an AI or diagnostic algorithm that would require expert-established ground truth on a clinical test set. The validation described is for software functionality and risk, not diagnostic accuracy.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/Not provided. As there's no mention of a clinical test set requiring expert interpretation for ground truth, there's no adjudication method described.

5. 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. The document does not describe an MRMC comparative effectiveness study or any study comparing human reader performance with or without AI assistance. The device is image processing and PACS software, not an AI-driven diagnostic aid.

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

Not explicitly described as a "standalone performance" study in the typical sense of diagnostic metrics. The document mentions "The software validation test was designed to evaluate all input functions, output functions, and actions performed by XmaruView V1... and Xmaru PACS." This implies internal functional testing of the software itself. However, it's not a study measuring diagnostic accuracy or classification performance in a clinical context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the clinical diagnostic sense. The "ground truth" for this software's validation would be its adherence to specified functional requirements, data integrity (e.g., DICOM compliance), and risk mitigation. There's no mention of clinical ground truth like pathology or expert consensus on disease presence.

8. The sample size for the training set

Not applicable. This document describes software validation for image processing and PACS systems, not a machine learning model that would have a "training set."

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

Not applicable. As there's no training set, there's no ground truth established for it.

Summary

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

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

April 8, 2016

Rayence Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025

Re: K160579

Trade/Device Name: Xmaru View V1(Xmaru Chiroview or Xmaru Podview) and Xmaru PACS, Medical Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 26, 2016 Received: March 1, 2016

Dear Mr. Kim:

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

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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/ResourcesforYou/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) K160579

Device Name

Xmaru View V1(Xmaru Chiroview or Xmaru Podview) and Xmaru PACS Medical Image Processing Software

Indications for Use (Describe)

Xmaru View V1(Xmaru Chiroview or Xmaru Podview) and Xmaru PACS can be packaged together or offered as a standalone imaging solution to be installed in a PC for trained medical professionals.

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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1. 510(k) Summary

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

Date 510K summary prepared: FEB. 26, 2016

Submitter's Name, address, telephone number, a contact person:

Submitter's Name :	Rayence Co., Ltd.
Submitter's Address:	14, Samsung 1-ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea
Submitter's Telephone:	+82-31-8015-6459
Contact person:	Mr. Kee Dock Kim / RA Team Manager / +82-31-8015-6459
Official Correspondent:	Dave Kim (davekim@mtech-inc.net)
Address:	8310 Buffalo Speedway, Houston, TX 77025
Telephone:	+713-467-2607
Fax:	+713-583-8988

Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:

Trade/proprietary name:	XmaruView V1, Xmaru Chiroview, Xmaru Podview andXmaru PACS
Common Name:	Medical Image Processing Software
Regulatoin number:	21 CFR 892.2050
Classification Name :	System, Image Processing, Radiological
Product Code:	LLZ

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2. Device Description

XmaruView V1(Xmaru Chiroview or Xmaru Podview) is a software program designed to provide image acquisition, processing and operational management functions for digital radiography.

Image /page/4/Figure/4 description: This image shows a diagram of the Xmaru PACS system. The diagram includes the XmaruView V1, Xmaru Chiroview, and Xmaru PodView software. The diagram also shows the different types of modalities that can be used with the system, such as DX, CR, CT, US, and MR. The image also shows the different clients that can be used to access the system, such as Client 1, Client 2, Client 3, and Client n.

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FunctionModel name	Basic	Chiropractic mode	Podiatry mode
XmaruView V1	O	X	X
Xmaru Chiroview	O	O	X
Xmaru Podview	O	X	O

Note) XmaruView V1 Naming Rules

3. Indication for use

XmaruView V1(Xmaru Chiroview or Xmaru Podview) software carries out the image processing and administration of medical X-ray data which includes adjustment of window leveling, rotation, zoom, and measurements. XmaruView V1(Xmaru Chiroview or Xmaru Podview) is not approved for mammography and is meant to be used by qualified medical personnel only. XmaruView V1(Xmaru Chiroview or Xmaru Podview) is complying with DICOM standards to assure optimum communications between network systems.

XmaruView V1(Xmaru Chiroview or Xmaru Podview) and Xmaru PACS can be packaged together or offered as a stand-alone imaging solution to be installed in a PC for trained medical professionals.

4. The Main Functions of XmaruView V1(Xmaru Chiroview or Xmaru Podview) and Xmaru PACS

The major functions of XmaruView V1(Xmaru Chiroview or Xmaru Podview) are as follows.

Automatic acquisition of patient information and photo-taking when taking a shot through the DICOM Worklist.
Auto Query that searches the Worklist server at every designated interval, facilitating to handle newly added works rapidly and efficiently.
Display an acquired image within a very short period of time after taking an image. -

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Reduce input time for patient information by automatically applying the preset Image Processing Parameter, ROI, Marker, LUT etc. according to different body parts.
Enables a user to take images simultaneously while conducting a variety of functions, including DICOM image transmission, printing, and Worklist search.
Provides a variety of image editing functions, including Contrast, Invert, Flip, Rotate, ROI, and Windowing.
Enable a user to edit images upon acquisition -
Image management functions: test creation, modify and delete of information, move and delete of image, and image storage management.
Supports DICOM 3.0 and image transmission to the PACS server, print and worklists. -
Chiropractic mode, Podiatry mode -

The major functions of Xmaru PACS are as follows.

Adjust images in real time through searching functions of acquired images -
Perform DICOM image sending and printing -
Provide various image processing functions such as contrast, invert, flip, rotate, ROI, windowing
Perform image searching, transferring, deleting, managing storage capacity easily -
Perform image sending to PACS, printing and Worklist because DICOM 3.0 is supported -
Provide Server and Client mode -

5. Predicate device

Manufacturer	: VATECH Co.,Ltd.
Device	: XmaruView V1
510(k) Number	: K102078 (Decision Date - AUG 10, 2011)
CharacteristiC	ProposedRayence Co.,Ltd.Xmaru View V1, XmaruChiroview, Xmaru Podview andXmaru PACS	PredicateVATECH Co.,Ltd.XmaruView V1
	* Rayence Co., Ltd - May, 2011(Separated from Vatech Co., Ltd. as an Independent Affiliate Company)
510(k) number		K102078Decision Date - AUG. 10, 2011
CharacteristiC	ProposedRayence Co.,Ltd.XmaruView V1, XmaruChiroview, Xmaru Podview andXmaru PACS	PredicateVATECH Co.,Ltd.XmaruView V1
Processor	Intel® Core™ i3 or higher	Intel Core Duo/Core 2 Duo CoreProcessor
RAM	4GB or higher	min. 1GByte RAM
Hard Disk	min. 80GByte	min. 80GByte
Network	100MBit or 1GBit	100MBit or 1GBit
OperationSoftware	Microsoft Windows 7(32 bit / 64 bit)ProfessionalMicrosoft Windows 8 Professional orEnterprise	Windows XP
Resolution	min. 1280 x 768	1280 x 1024
X-rayGeneratorControl	XmaruView V1(Xmaru Chiroviewor Xmaru Podview) – YesXmaru PACS - No	Yes
ImageProcessing	Yes (same with the predicate device)	Yes
Windowing	Yes	Yes
ImageFormatting	Yes (1x1,1x2,2x1,2x2,3x3)	Yes (1x1,1x2,2x1,2x2,3x3)
Electronic zoom	Yes	Yes
Image rotation	Yes	Yes
DICOMWorklist	Yes	Yes
DICOM Store	Yes	Yes
CharacteristiC	ProposedRayence Co.,Ltd.Xmaru View V1, XmaruChiroview, Xmaru Podview andXmaru PACS	PredicateVATECH Co.,Ltd.Xmaru View V1
DICOM Print	Yes	Yes
SW Ver.	XmaruView V1(Xmaru Chiroviewor Xmaru Podview) - 2.0Xmaru PACS - 1.0	Xmaru View V1 -1.0
AddedFunctions	XmaruView V1(Xmaru Chiroviewor Xmaru Podview) - 2.01. Add features- Auto Stitching2. Improve features- Change Image Processing Tab- GPR parameter selectable3. Added mode- Chiropractic mode- Podiatry mode4. Xmaru View V1 divided themodel name.- XmaruView V1- Xmaru Chiroview- Xmaru PodviewXmaru PACS - 1.01. Store SCP :Ability to receive imagestransmitted from modalities2. Available Modality ImageDisplayDX, CR, CT, MR, MG, US andPET image modalities

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6. Substantial Equivalence

The subject device and predicate device are substantially equivalent, having the same/similar indications for use and functionalities like operation software, resolution, X-ray generator control, image processing, windowing, zoom, rotation, DICOM worklist, DICOM store and DICOM print. Both subject device and predicate devices are categorized in product code

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LLZ; equivalence between these models is evident.

1. The pre / post image processing algorithm is the same for XmaruView V1( ver 1.0) and XmaruView V1( ver 2.0).

The differences betweeen XmaruView V1 (ver 1.0) and XmaruView V1 (ver 2.0) are as follows:

1). Add features
Auto Stitching
2). Improve features
Change Image Processing Tab
Selectable GPR parameter
3). Added mode
Chiropractic mode
Podiatry mode
4). XmaruView V1 divided into different model names.
XmaruView V1
Xmaru Chiroview
Xmaru Podview

The SW Validation, hazard analysis and FMEA, modality validation and functional test were conducted for the software features which are added or changed from XmaruView V1 (ver 1.0), the previous version. The risks identified have been mitigated and any residual risks were evaluated and accepted for XmaruView V1 (ver 2.0).

Chiropractic mode and Podiatry mode in XmaruView V1 ( ver 2.0) are additional features for XmaruView V1 ( ver 2.0). However, they are similar to the measurement function of length and angle already incorporated in XmaruView V1 (Ver 1.0) For the user convenience, a specific region of interest for chiropractic and podiatry was designated as a dedicated mode in XmaruView V1 ( ver 2.0).

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7.Summary of Performance Testing

Nonclinical Testing:

The complete system configuration has been assessed and tested by the manufacturer and passed all in-house testing criteria. The software validation test was designed to evaluate all input functions, output functions, and actions performed by XmaruView V1(Xmaru Chiroview or Xmaru Podview) and Xmaru PACS. Each operational mode and the process followed are documented in the Software Validation Report.

The validation testing verified and validated the risk analysis and individual performance results were within the predetermined acceptance criteria.

Safety and Performance Data:

IEC 62304 Medical device software Software life-cycle processes : 2006
ISO 14971 Medical Devices Application of risk management to medical device : 2007
NEMAPS 3.1-3.20 Digital Imaging and Communications in Medicine (DICOM) Set (Radiology)

8. Conclusions

None of the modifications alter the Indications for Use in a significant way, nor the fundamental scientific technology, and do not introduce a fundamentally new scientific technology. Therefore, it is our opinion that the XmaruView V1(Xmaru Chiroview or Xmaru Podview) described in this submission is substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).