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. Ymaru View V (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.

Device Description

XmaruView V1 is a software program designed to provide image acquisition, processing and operational management functions for Digital Radiography. XmaruView V1 performs connects with Flat-Panel Detectors and Generator to acquire digital images. The software also manages information on patients, tests and images through an internal database. It also supports DICOM which allows excellent compatibility with other radiography equipment and network programs. XmaruView V1 provides a streamlined process of multiple workflows. This optimizes any hospital environment for digital radiography.

AI/ML Overview

The provided document is a 510(k) summary for the XmaruView V1 software, including its variants Xmaru Chiroview and Xmaru Podview. This document focuses on demonstrating substantial equivalence to a predicate device and details the software's functionalities and validation rather than presenting a performance study with specific acceptance criteria and detailed results from a clinical trial or large-scale evaluation.

Therefore, many of the requested details regarding acceptance criteria, study performance, sample sizes, expert involvement for ground truth, and MRMC studies are not explicitly stated or applicable in the context of this 510(k) submission, which is primarily a declaration of equivalence and software validation against internal testing.

However, based on the information provided, here's what can be extracted and inferred:

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

The document states that the software validation test was "designed to evaluate all input functions, output functions, and actions performed by XmaruView V1." It also mentions that "the risk analysis and individual performance results were within the predetermined acceptance criteria." However, the specific acceptance criteria (e.g., quantitative metrics like accuracy, sensitivity, specificity, or specific error rates) and the reported device performance against these criteria are not detailed in this 510(k) summary. These would typically be found in the manufacturer's internal validation reports, which are summarized but not fully presented here.

The main functional acceptance criteria implied are:

Ability to perform image acquisition and processing (window leveling, rotation, zoom, measurements).
Compliance with DICOM standards for communication.
Reliable management of patient, test, and image information.
Proper functioning of the "Grid ON" feature (for the upgraded version).

Acceptance Criteria (Implied from functions and safety)	Reported Device Performance
Image acquisition and processing functions work as intended (window leveling, rotation, zoom, measurements, contrast, invert, flip, ROI).	"passed all testing acceptance criteria." "The software validation test was designed to evaluate all input functions, output functions, and actions performed by XmaruView V1."
Compliance with DICOM standards (Worklist, Store, Print).	"complying with DICOM standards to assure optimum communications between network systems." "Supports DICOM 3.0 and image transmission to the PACS server, print and Worklist jobs."
Management of patient, test, and image information.	"manages information on patients, tests and images through an internal database." "Image management functions: test creation, modify and delete of information, move and delete of image, and image storage management."
"Grid ON" function performs as designed to enhance contrast and reduce scatter effects.	"XmaruView V1 SW is updated with Grid ON function to enhance contrast for image, Grid On function is related to Virtual grid where physical grid is not used." Performance details not quantified.
Software safety and risk mitigation.	"The SW validation and risk analysis based on FMEA were conducted. The risks identified have been mitigated and any residual risks were evaluated and accepted." Compliance with IEC 62304 and ISO 14971 cited.

2. Sample sizes used for the test set and the data provenance

The document does not specify a "test set" in the sense of a distinct set of clinical images used for a performance study. The validation described is primarily a software validation and risk analysis (IEC 62304, ISO 14971), which involves testing the software's functionality and safety internally. This is not a clinical performance study using patient data with a defined sample size for generalization.

Sample Size for Test Set: Not specified. The validation described is internal software testing, not a clinical study on a dataset of patient images.
Data Provenance: Not specified. Given it's internal software validation, it's likely using test data generated by the manufacturer or potentially anonymized internal clinical data, but this is not detailed. It is not specified as retrospective or prospective clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided as the submission describes software functional and safety validation, not a diagnostic performance study requiring expert-established ground truth on a clinical image set.

4. Adjudication method for the test set

This information is not applicable and not provided as there is no described clinical "test set" requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study was not done and is not described in this 510(k) summary. The device is image processing software (a PACS component with additional features), not an AI-assisted diagnostic tool that helps human readers. Its primary function is image display, manipulation (zoom, rotation, etc.), and management, including a "Grid ON" feature for image enhancement. It does not provide diagnostic insights or AI assistance to human readers for interpretation.

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

The device is image processing software; it doesn't perform diagnostic functions as a standalone algorithm. Its "performance" is in its ability to correctly acquire, process, and display images and manage data. The validation described is focused on the correct functioning of the software itself ("evaluate all input functions, output functions, and actions performed by XmaruView V1").

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

Not applicable in the context of a diagnostic ground truth, as this is software validation. The "ground truth" for the software validation would be based on predefined specifications for how each function should operate and the expected output for given inputs. For example, applying a "rotate 90 degrees" function would be validated by checking if the image is indeed rotated by 90 degrees.

8. The sample size for the training set

Not applicable and not specified. This is not an AI/machine learning device that requires a training set. The "Grid ON" function might involve an algorithm, but it's not described as a deep learning model requiring a large training dataset in the context of this submission.

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

Not applicable and not specified, as this is not an AI/machine learning device with a training set.

Summary

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April 30, 2019

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

Re: K190866

Trade/Device Name: XmaruView V1 (Xmaru Chiroview, Xmaru Podview) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: March 29, 2019 Received: April 3, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,

For

Thalia T. Mills, 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) K190866

Device Name XmaruView V1 Xmaru Chiroview Xmaru Podview

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X 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) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date 510K summary prepared: April 9, 2019

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:

Type of 510k Submission:	Special
Trade/proprietary name:	XmaruView V1 (Xmaru Chiroview or Xmaru Podview)
Common Name:	Medical Image Processing Software
Regulation number:	21 CFR 892.2050
Classification Name:	Picture archiving and communications system
Product Code:	LLZ
Predicate device (K160579)
Manufacturer:	Rayence Co., Ltd.
Device Name :	XmaruView V1 (Xmaru Chiroview or Xmaru Podview) andXmaru PACS
510(k) Number:	K160579 (Decision Date - Apr 08, 2016)
Common Name:	Medical Image Processing Software
Regulation number:	21 CFR 892.2050
Classification Name :	Picture archiving and communications system
Product Code:	LLZ
Reference device (K153464)
Manufacturer:	FUJIFILM Medical Systems U.S.A., Inc.
Device Name :	FDR D-EVO Flat Panel Detector System (DR-ID600) withimproved virtual grid software
510(k) Number:	K153464 (Decision Date – Apr 08, 2016)
Common Name:	Flat Panel Digital Detector System
Regulation number:	21 CFR 892.1680
Classification Name :	Stationary X-ray system
Product Code:	MQB

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2. Device Description

XmaruView V1 is a software program designed to provide image acquisition, processing and operational management functions for Digital Radiography.

XmaruView V1 performs connects with Flat-Panel Detectors and Generator to acquire digital images. The software also manages information on patients, tests and images through an internal database. It also supports DICOM which allows excellent compatibility with other radiography equipment and network programs. XmaruView V1 provides a streamlined process of multiple workflows. This optimizes any hospital environment for digital radiography.

Image /page/4/Figure/4 description: The image shows a diagram of the XmaruView V1 software architecture. The diagram is divided into three main sections: Viewer Window, Main Window, and External Connection. The Viewer Window section includes modules for image acquisition, post-image processing, thumbnail list, image display, and a side toolbar. The Main Window section is divided into two tabs: Study List and Worklist, each containing modules for study management and data management.

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.

4. The Main Functions of XmarView V1

The major functions of XmaruView V1 are as follows.

Automatic acquisition of patient information and photo-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. -
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.
Grid ON function is to reduce the effects of scatter radiation and to enhance contrast for image .
Enable a user to edit images upon acquisition
Image management functions: test creation, modify and delete of information, move and

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delete of image, and image storage management.

Supports DICOM 3.0 and image transmission to the PACS server, print and Worklist jobs. -

5. Interoperation products

XmaruView V1 are compatible with the following detectors and generators:

-Rayence's Detector
- -Generator
  - EDITOR HFe 501(Spellman) 1
  - CMP200(CPI)
  - SYNERGY(SUMMIT)
  - System
SU-3000/RU-3000(SYFM) .

6. Substantial Equivalence

XmaruView V1 SW and the predicate device(K160579), XmaruView V1 image viewer software are substantially equivalent, having the same indications for use and functionalities such as image processing, windowing, zoom, rotation, contrast, brightness, inverting view, annotation, DICOM worklist, DICOM store and DICOM print. The differences are hardware operation environment and Grid ON processing parameter. Both subject device and predicate device are categorized as the product code LLZ; equivalence between the subject and predicate device is evident.

The differences between the subject and predicate device are as follows:

The proposed device, XmaruView V1 is an upgrade version of the predicate device (K160579). XmaruView V1 SW is updated with Grid ON function to enhance contrast for image, Grid On function is related to Virtual grid where physical grid is not used. Grid On is a software algorithm designed to improve image contrast in general radiographic images by reducing the effects of scatter radiation. primarily for exams acquired without a grid. However. Grid On function should be turned off to acquire images with a real grid.

The difference is not significant since they are additional features for user convenience and do not raise new safety or effectiveness concerns. Based on the validation submitted in this 510(k) submission, we conclude that the proposed device is substantially equivalent to the predicate device.

7.Summary of Performance Testing

1. The complete system configuration has been assessed and tested by the manufacturer and passed all testing acceptance criteria. The software validation test was designed to evaluate all input functions, output functions, and actions performed by XmaruView V1. Each operational mode and the processes 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.
1. Safety and Performance Data:
  The SW validation and risk analysis based on FMEA were conducted. The risks identified have been mitigated and any residual risks were evaluated and accepted.
IEC 62304 Medical device software Software life-cycle processes : 2006
ISO 14971 Medical Devices Application of risk management to medical device : 2007

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 determined that the XmaruView V1 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).