1417WGC Digital Flat Panel X-Ray Detector 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.

Device Description

1417WGC is a wired/wireless digital solid state X-ray detector that is based on flat-panel technology. The wireless LAN(IEEE 802.11a/g/n) communication signals images captured to the system and improves the user operability through high-speed processing. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize X-ray images for radiographic diagnosis The RAW files can be further processed as DICOM compatible image files by separate console SW (not part of this 510k submission) for a radiographic diagnosis and analysis.

AI/ML Overview

The provided 510(k) submission describes the Rayence 1417WGC Digital Flat Panel X-ray Detector. This device is a modification of a previously cleared device, the 1417WGA. The submission focuses on demonstrating substantial equivalence to the predicate device rather than presenting acceptance criteria against a specific benchmark or a comprehensive study proving new clinical efficacy. Instead, the "acceptance criteria" are implicitly the performance of the predicate device, 1417WGA, and the "study that proves the device meets the acceptance criteria" is a comparative performance evaluation.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Criteria (Predicate: 1417WGA Performance)	Reported Device Performance (1417WGC)
Image Quality - MTF	Performance of 1417WGA	"almost same with 1417WGA"
Image Quality - DQE	Performance of 1417WGA (e.g., 46% at lowest SF)	Higher than 1417WGA at various spatial frequencies (e.g., 49% at lowest SF); "provides almost same Signal to Noise Ratio (SNR) transfer from the input to the output of a detector as a function of frequency."
Image Quality - NPS	Performance of 1417WGA	"almost same performance with 1417WGA"
A/D Conversion	14 bit	14 / 16 bit (improved capability)
Physical Dimensions	460 x 417 x 15.9 mm	460 x 384 x 15.4 mm (thinner and lighter)
Weight	3.9 kg	3.1 kg (lighter)
Wireless Specifications (Standard)	802.11a/g/n compliance	802.11a/g/n compliance (same)
Wireless Specifications (Peak Rate)	300Mbps	300Mbps (same)
Wireless Specifications (Frequency)	2.4 GHz / 5 GHz	2.4 GHz / 5 GHz (same)
Wireless Specifications (Bandwidth)	20MHz/40MHz	20MHz/40MHz (same)
Wireless Specifications (MIMO)	2x2	2x2 (same)
Safety (Electrical, Mechanical, Environmental)	Compliance with IEC 60601-1:2005 + CORR.1(2006) + CORR(2007) and IEC 60601-1-2:2007	"All test results were satisfactory." (Implies compliance with the same standards)
Clinical Readability	Acceptable image quality for diagnostic procedures by a licensed US radiologist based on 1417WGA.	"comparable or superior to the same view obtained from a similar patient with the 1417WGA," with "superior" spatial resolution and soft tissue contrast on 1417WGC. "No difficulty in evaluating a wide range of anatomic structures necessary to provide a correct conclusion." (Expert opinion after review of clinical images).

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

Non-clinical Test Set (MTF, DQE, NPS): Sample sizes are not explicitly stated for these tests, but they were conducted using "identical test equipment and same analysis method described by IEC 6220-1." These are laboratory measurements on the devices themselves.
Clinical Test Set: Sample size is not explicitly stated. The text mentions "taking sample radiographs of similar age groups and anatomical structures."
Data Provenance: Not explicitly stated, but given the manufacturer (Rayence Co., Ltd.) is from Korea, and the clinical review was performed by a "licensed US radiologist," it's likely the non-clinical tests were conducted in Korea, and the clinical images could have been acquired there or elsewhere, then reviewed by a US radiologist for the submission. The study is retrospective in the sense that images were "taken" and then "reviewed" for comparative analysis.

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

Number of Experts: One ("a licensed US radiologist").
Qualifications: "licensed US radiologist." No specific experience level (e.g., "10 years of experience") is mentioned.

4. Adjudication Method for the Test Set

The adjudication method used for the clinical image review was none, as only one expert reviewed the images from both devices. The expert provided a direct comparative opinion.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly conducted or reported. The clinical evaluation involved a single licensed US radiologist comparing images from the two devices. There is no mention of human readers improving with AI vs. without AI assistance, as this is a comparison between two digital X-ray detectors, not an AI-assisted diagnostic system.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

This is not applicable in the context of this submission. The 1417WGC is a digital X-ray detector, a hardware device that captures images. It does not incorporate an AI algorithm for diagnostic interpretation in a standalone capacity. The performance metrics (MTF, DQE, NPS) are standalone evaluations of the detector's physical image quality characteristics.

7. Type of Ground Truth Used (for the comparative study)

The "ground truth" for the clinical comparison was the expert opinion (expert consensus of one radiologist) on the diagnostic image quality of the radiographs. The goal was to establish "substantial equivalency" in terms of image quality for diagnostic procedures, not to detect specific pathologies.

8. Sample Size for the Training Set

This concept is not applicable here as the device is a hardware X-ray detector, not an AI algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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510(k) Submission — 1417WGC

510(k) Summary

JUL 16 2014

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: June 11, 2014

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 / Manager / +82-31-8015-6459
Official Correspondent:	Dave Kim (davekim(@mtech-inc.net)
(U.S. Designated agent)
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:	1417WGC
Common Name:	Digital Flat Panel X-ray Detector
Classification Name :	21CFR892.1680 / Stationary x-ray system
Product Code:	MQB

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Predicate Device :

Manufacturer	: Rayence Co., Ltd.
Device	: 1417WGA
510(k) Number	: K131114 (Decision Date - September 17, 2013)

Device Description :

Indication for use :

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1. Summary of Design Control Risk management

The 1417WGC digital X-ray detector is a modification of 1417WGA (K131114). The new device is designed with a thinner and lighter body compared to its predecessor, 1417WGA. The battery of 1417WGA was attached on the back of the device but the newly designed 1417WGC device has its battery inserted inside the new device.

In addition, a dedicated power supply (model name: RP003A) for 1417WGC is developed and added to its component list. (Optional user selection).

The risks and the hazardous impact of the device modification were analyzed with FMEA method. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented in the new product design phase. The overall assessment concluded that all risks and hazardous conditions identified arising from the design change were successfully mitigated and accepted.

2. Summary of the technological characteristics of the device compared to the predicate device:

The 1417WGC SSXI detector described in this 510(k) has the same indications for use and technical characteristics as its predicate device, 1417WGA flat panel detector, of Rayence Co., Ltd.

2.1 Detector

The mechanical design for each device is different as following.

Image /page/2/Figure/9 description: This image shows an exploded diagram of a product, with labels indicating the different components. The components are labeled 1 through 6, and include the carbon plate, carbon case, PC sheet assembly, middle block assembly, main board, and cap assembly. The image also includes the product names 1417WGC and 1417WGA, along with their dimensions and weights. The dimensions for 1417WGC are 460 x 384 x 15.4 mm with a weight of 3.1 kg, while the dimensions for 1417WGA are 460 x 417 x 15.9 mm with a weight of 3.9 kg.

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Image /page/3/Figure/1 description: This image shows an exploded view of a device with its components labeled. The components are: 1. Carbon Plate, 2. Front cover, 3. Middle block & Panel, 4. Rear Cover, 5. Battery Pack, and 6. Handle. The exploded view shows how the components fit together to form the device.

2.2 Power supply

1417WGC requires power supply (Model Name: RP003A)

	1417WGC	1417WGA
Model Name	RP003A
	Image: RP003A device
	Image: Connectors	The power supplyunit is not providedfrom Rayence.
	① Power plug connector: Connect withAC power supply cord② LAN connector : Ethernet port fortransmitting the image/command betweendetector and PC③ Link cable connector: Power connectorfor detector operating④ LED indicator: Four LEDs to displaythe status*Changeable part: Fuse T3.15 AL 250V
Manufacturer	Rayence Co., Ltd.

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510(k) Submission - 1417WGC

Dimension	188 X 92 X 41.5 mm
Weight	0.46 kg
		* Use CE or UL approved product
Powerrequirements	Input rate : 100~240VAC (50/60Hz)Output : Typ. 24VDC (Max 1.6A)		Min	Max
		Voltage	18V	24V
		Current	1.9A

The 1417WGC flat panel detector is equipped with a dedicated power supply (Model Name: RP003A). The electromagnetic compatibility test for the new device with the power supply has been conducted and the test report is included in this submission. The risk factors associated with the power supply such as power overload and overheating have been assessed and control measures to mitigate risks are discussed.

2.3 A/D conversion (analog-to-digital conversion)

The detector displays an image by digitizing and recording DN value of the analog electrical signal measured. The predicate device used 14 bit series to represent 16,384 values on the gray scale whereas the newly improved subject device is capable of processing both 14 and 16 bit (65,536 gray scale values) series based on the user needs and market requirements.

Characteristic	ProposedRayence Co.,Ltd.1417WGC	PredicateRayence Co.,Ltd.1417WGA
A/Dconversion	14 / 16 bit	14 bit

2.4 Recommended Generator Specification

Model	Manufacture	Specification
CMP 200	Communications & PowerIndustries	32kW	40kW	50kW
		kVp	40-125	40-150
		mA	10-400	10-500

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510(k) Submission - 1417WGC

EDITOR HFe 501	Rontgenwerk Bochum	kVp	40-150
		mA	10-630
UD150L-40E/40F	Shimadzu	kVp	40-150
		mA	@100 kVp- 500(320)
		mA	@80 kVp- 630(400)
PXR-321B	Poskom Co.,Ltd.	kVp	125/150
		mA	500

ा

Note: To our best knowledge, the 1417WGC detector is compatible with the X-ray generators with the specifications described above. For any questions regarding the compatibility issue for other generators which are not listed above, please contact Rayence representative.

3. Proposed Labeling- Changes in comparison to the predicate device

Item	Difference	1417WGC	1417WGA
DeviceLabe1	Detector	Image: Detector label for 1417WGC	Image: Detector label for 1417WGA
	PowerSupply	Image: Power supply label for 1417WGC	-
Manual	Indications forUse	1417WGC Digital Flat PanelX-Ray Detector is indicated fordigital imaging solutiondesigned for generalradiographic system forhuman anatomy. It is intendedto replace film or screen basedradiographic systems in allgeneral purpose diagnostic	1417WGA Digital Flat Panel X-Ray Detector is indicated fordigital imaging solution designedfor general radiographic systemfor human anatomy. It isintended to replace film or screenbased radiographic systems in allgeneral purpose diagnosticprocedures. Not to be used formammography.

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		procedures. Not to be used formammography.
	ProductSpecification	(page 25)Pixel matrix: 3328 x 2816Pixel area (active): 415 x 350mmDimensions : 460 x 384 x15.4 mmWeight: 3.1 kg	(page 25)Pixel matrix: 3328 x 2816Pixel area (active): 415 x 350mmDimensions : 460 x 417 x 15.9mmWeight: 3.9 kg
WirelessSpec	Standard	802.11a/g/n compliance	802.11a/g/n compliance
	PeakRate	300Mbps	300Mbps
	Frequency	2.4 GHz / 5 GHz	2.4 GHz / 5 GHz
	Bandwidth	20MHz/40MHz	20MHz/40MHz
	MIMO	2×2	2×2

4. Summary of Performance Testing

The 1417WGC flat panel detector is a modified version of 1417WGA (K131114), FDA cleared predicate device from Rayence. Indications for use, material, form factor, performance, and safety characteristics between 1417WGC and 1417WGA are identical.

The non-clinical test report and clinical consideration report were prepared and submitted to FDA separately to demonstrate the substantial equivalency between two similar detectors. The nonclinical test report contains the MTF, DQE and NPS test results of 1417WGC and 1417WGA by using the identical test equipment and same analysis method described by IEC 6220-1. The comparison of the MTF for 1417WGC and 1417WGA detector demonstrated that the MTF of the 1417WGA detector performed almost same with 1417WGC. Therefore, the overall resolution performance and sharpness of 1417WGC is almost same with 1417WGA. The DQE represents the ability to visualize object details of a certain size and contrast. 1417WGC demonstrated higher DOE performance than 1417WGA at various spatial frequencies and provides almost same Signalto Noise Ratio (SNR) transfer from the input to the output of a detector as a function of frequency. At the lowest spatial frequency, 1417WGC has a DQE of 49% and that of 1417WGA is 46%. 1417WGC also exhibited NPS which has almost same performance with 1417WGA. Therefore, the image quality of 1417WGC is found to be substantially equivalent to 1417WGA at the same patient exposure.

To further demonstrate the substantial equivalency of two devices, clinical images are taken from both devices and reviewed by a licensed US radiologist to render an expert opinion. Both the test subject (1417WGC) and control group (1417WGA) are evaluated and compared by taking sample radiographs of similar age groups and anatomical structures in accordance with the test protocol of diagnostic radiography evaluation procedure.

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Based on the non-clinical and clinical consideration test and the outcome of a comparative review by an expert for both devices, we can claim the substantial equivalency between 1417WGC and its predicate device, 1417WGA in terms of image quality.

After comparing a broad review of plain radiographic images taken with the 1417WGC and the 1417WGA, the images obtained with the 1417WGC are comparable or superior to the same view obtained from a similar patient with the 1417WGA. In general, both the spatial resolution and soft tissue contrast are superior using the 1417WGC. Specifically, the soft tissues on extremity films were seen with better clarity. There is no difficulty in evaluating a wide range of anatomic structures necessary to provide a correct conclusion.

The manufacturing facility is in conformance with the design control procedure requirements and the relevant EPRC standards as specified in 21 CFR 802.30 and the records are available for review.

5. Summary for any testing in the submission:

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1: 2005 + CORR.1(2006) + CORR(2007) (Medical electrical equipment Part 1:General requirements for basic safety and essential performance) was performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2:2007.

Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed.

All test results were satisfactory.

6. Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Rayence Co., Ltd. concludes that 1417WGC is safe and effective and substantially equivalent in comparison with 1417WGA, the predicate device as described herein.

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Image /page/8/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above two wavy lines.

Public Health Service

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

July 16, 2014

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

Re: K141563

Trade/Device Name: Solid State X-ray Imaging Device, Digital Flat Panel X-ray Detector,

1417wgc Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: June 12, 2014 Received: June 16, 2014

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. Ilisting 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 or any I 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 clectronic form in the quand of oversions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Kim

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/ReportalProblem/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,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K141563

Device Name

1417WGC Digital Flat Panel X-Ray Detector

Indications for Use (Describe)

1417WGC Digital Flat Parel X-Ray Detector 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

$(m,p)$

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Regulation Number and Section

N/A