1417WGA 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

1417WGA is a wired/wireless digital X-ray flat panel detector that can acquire radiographic images of human anatomy when used with existing radiographic x-ray systems. 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 X-ray imaging detector consists of a scintillator directly coupled to an a-Si TFT sensor. 1417WGA is designed specifically to be integrated with a console PC system and X-Ray generator to digitalize x-ray images into RAW files. The RAW files can be made to DICOM compatible image files which can be viewed by console SW for a radiographic image diagnosis and analysis.

AI/ML Overview

This submission is for a digital flat panel X-ray detector, 1417WGA, which is very similar to a previously cleared device, 1417PGA. The study conducted to demonstrate substantial equivalence primarily relied on comparing the new device against the predicate device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantified table format for the new device (1417WGA). Instead, the performance of the 1417WGA is compared directly to the predicate device (1417PGA), with the implication that performing "almost same" as the predicate device meets the acceptance criteria for substantial equivalence.

Characteristic	Acceptance Criteria (Implied: "almost same as 1417PGA")	Reported Device Performance (1417WGA)	Predicate Device Performance (1417PGA)
Image Quality (MTF)	"almost same" as 1417PGA	"performed almost same with 1417PGA"	-
Image Quality (DQE)	"almost same" as 1417PGA	"demonstrated almost same DQE performance"	42% (at lowest spatial frequency)
DQE (at lowest spatial freq.)	"almost same" as 1417PGA	41%	42%
Image Quality (NPS)	"almost same" as 1417PGA	"exhibited NPS which has almost same performance"	-
SNR Transfer	"almost same" as 1417PGA	"provides almost same Signal-to Noise Ratio (SNR) transfer"	-
Clinical Image Review	Images from 1417WGA are comparable to 1417PGA by expert opinion	Clinical images reviewed by a licensed US radiologist, expert opinion supports substantial equivalency	-
Safety & EMC	Compliance with IEC 60601-1, IEC 60601-1-2, FCC Rule part(s) 47CFR PART 15.107(B) / 47CFR PART 15.109(G) CLASSB	All test results were satisfactory for these standards	-

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

Non-clinical Test Set: The document does not specify a quantitative sample size for the non-clinical tests (MTF, DQE, NPS). It states that both 1417WGA and 1417PGA were tested using identical equipment and analysis methods.
Clinical Test Set: The document simply states "clinical images are taken from both devices" (1417WGA and 1417PGA). A specific number of images or patients is not provided.
Data Provenance: Not explicitly stated, but the company is based in South Korea. The U.S. Designated agent is in Houston, TX. No specific country of origin for the data is mentioned. The study is retrospective as it compares the new device to a predicate device that was already cleared and presumably has a history of use.

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

Number of Experts: "a licensed US radiologist" (singular).
Qualifications of Experts: "a licensed US radiologist." No further details on years of experience or specialization are provided.

4. Adjudication Method for the Test Set:

The document implies a "none" adjudication method in the traditional sense of multiple readers coming to an agreement. It states that "clinical images are taken from both devices and reviewed by a licensed US radiologist to render an expert opinion." This suggests a single expert's opinion was sufficient for the comparison.

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

No, a MRMC comparative effectiveness study was not explicitly conducted or reported. The clinical evaluation was based on a single expert's review of images from both devices, not a study comparing human reader performance with and without AI assistance. The device itself is a detector, not an AI interpretation tool.

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

Yes, the non-clinical performance tests (MTF, DQE, NPS) are considered standalone (algorithm/device-only) evaluations as they measure the intrinsic physical performance of the detector. The device itself is a detector, not an "algorithm" in the sense of AI.

7. Type of Ground Truth Used:

Non-clinical Tests: Ground truth is established by standardized physical measurements (e.g., MTF, DQE, NPS measurements according to IEC 6220-1).
Clinical Review: Ground truth is established by expert opinion/consensus from a licensed US radiologist comparing images from the two devices according to established diagnostic radiography evaluation procedures.

8. Sample Size for the Training Set:

This information is not applicable/not provided. The device is an X-ray detector, not a machine learning algorithm that requires a "training set" for its operation. The performance is based on its physical and electronic characteristics.

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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K131114
Page 1 of 5
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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 510K summary prepared: April 19, 2013

7 2013

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

Submitter's Name :	Rayence Co., Ltd.
Submitter's Address:	1F, 2F, 3F, #402, 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
Official Correspondent:	Dave Kim (davekim@mtech-inc.net)
(U.S. Designated agent)
Address:	12946 Kimberley Ln, Houston, TX 77079
Telephone:	+713-467-2607
Fax:	+713-464-8880

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:	1417WGA
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	: 1417PGA
510(k) Number	: K122928 (Decision Date - JAN. 30. 2013)

Device Description :

Indication for use :

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

The 1417WGA SSXI detector described in this 510(k) has the same indications for use and same technical characteristics as its predicate device. 1417GA flat panel detector, of Rayence Co., Ltd. Table 1 summarizes the technological characteristics of the 1417WGA and 1417GA. the predicate device.

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Characteristic	ProposedRayence Co.,Ltd.1417WGA	PredicateRayence Co.,Ltd.1417PGA
510(k) number	-	-K122928
Intended Use	1417WGA Digital Flat Panel X-Ray Detector is indicated fordigital imaging solution designedfor general radiographic systemfor human anatomy. It is intendedto replace film or screen basedradiographic systems in allgeneral purpose diagnosticprocedures. Not to be used formammography.	1417PGA Digital Flat Panel X-Ray Detector is indicated fordigital imaging solution designedfor general radiographic systemfor human anatomy. It is intendedto replace film or screen basedradiographic systems in allgeneral purpose diagnosticprocedures. Not to be used formammography.
Detector Type	Amorphous Silicon, TFT	Amorphous Silicon, TFT
Scintillator	Gadolinium Oxysulfide	Gadolinium Oxysulfide
Imaging Area	14 x 17 inches	14 x 17 inches
Total PixelNumber	3328 x 2816 pixels	3328 x 2816 pixels
Pixel pitch	127 um	127 um
Resolution	3.9 lp/mm	3.9 lp/mm
A/D conversion	14 bit	14 bit
Preview Image	2~~3 seconds (wired)/ 3~~5 seconds (wireless)	2~3 seconds
Data output	RAW*The RAW files areconvertible into DICOM 3.0by console S/W	RAW*The RAW files areconvertible into DICOM 3.0by console S/W
Dimensions	460 x 417 x 15.9 mm	460 x 417 x 15.9 mm
Weight	3.6 kg (incl. battery pack)	3.4 kg
Application	Wireless portable systemAvailable with upright stand,table, universal stand	Portable systemAvailable with upright stand,table, universal stand
Feature	Image: portable system	Image: portable system

Table I: Comparison of 1417WGA and 1417PGA

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510(k) Submission - 1417WGA

Table 2: Size Comparison of 1417WGA and 1417PGA

Item	Unit	1417WGA	1417PGA
Pixel Pitch	μm	127 x 127	127 x 127
Total Pixel Number	pixels	3328 x 2816	3328 x 2816
Effective Pixel Area	mm	415 x 350	415 x 350
Effective Pixel Number(lightsensitive)	pixels	3268x 2756	3268x 2756
Fill factor	%	61.03	61.03
Weight	Kg	3.6 Kg	3.4 Kg

Summary of Performance Testing:

The wireless/wired 1417WGA flat panel detector is a modified version of 1417PGA (K122928), FDA cleared predicate device from Rayence. Indications for use, material, form factor, performance, and safety characteristics between 1417WGA and 1417PGA are the same. The non-clinical test report and clinical consideration report were prepared and submitted to FDA separately to demonstrate the substantial equivalency between two different detectors. The non-clinical test report contains the MTF, DQE and NPS test results of 1417WGA and 1417PGA by using the identical test equipment and same analysis method described by IEC 6220-1 The comparison of the MTF for 1417WGA and 1417PGA detector demonstrated that the MTF of the 1417WGA detector performed almost same with 1417PGA. Therefore the overall resolution performance and sharpness of 1417WGA is almost same with 1417PGA. The DQE represents the ability to visualize object details of a certain size and contrast. 1417WGA demonstrated almost same DQE

Rev.0

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performance with 1417PGA at various spatial frequencies and provides almost same Signal-to Noise Ratio (SNR) transfer from the input to the output of a detector as a function of frequency. At the lowest spatial frequency, the 1417WGA has a DQE: of 41% and that of 1417PGA is 42%. 1417WGA exhibited NPS which has almost same performance with 1417PGA. Therefore, the image quality of 1417WGA is almost same with 1417PGA 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 test (1417WGA) and control group (1417PGA) are evaluated according to similar age group and anatomical structures were compared in accordance with the test protocol of diagnostic radiography evaluation procedure.

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 1417WGA and its predicate device, 1417PGA in terms of image quality.

Safety, EMC and Performance Data :

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1:1988 + A1:1991 + A2:1995 (Medical electrical equipment Part 1: General Requirements for Safety) was performed, and EMC testing were conducted in accordance with standard IEC60601-1-2:2007 (CISPR 11:2009/A1: 2010), EN60601-1-2:2007 +A1:2010 (Medical electrical equipment - Part 1-2: General Requirements for safety -- Collateral Standard : Electromagnetic Compatibility Requirements and tests). The equipment also complies with the standard FCC Rule part(s) 47CFR PART 15.107(B) / 47CFR PART 15.109(G) CLASSB. All test results were satisfactory.

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 1417WGA is safe and effective and substantially equivalent in comparison with 1417PGA, , the predicate device as described herein.

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

September, 17, 2013

Ravence Co. Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 12946 Kimberley Lane HOUSTON TX 77079

Re: K131114

Trade/Device Name: Digital Flat Panel X-ray Detector/1417WGA Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: August 30, 2013 Received: September 4, 2013

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Smh)

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): K131114

Digital Flat Panel X-Ray Detector /1417WGA Device Name:

Indications for Use:

Prescription Use (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)

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

K131114 510(k)

Page 1 of 1

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.