1417WCA 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

1417WCA 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. 1417WCA 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 for the 1417WCA Digital Flat Panel X-ray Detector from Rayence Co., Ltd. does not contain a typical acceptance criteria table with performance metrics and a detailed study proving the device meets those criteria in the way AI/CADe devices often do. Instead, this 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (1417PCA) through non-clinical and clinical comparison.

The "acceptance criteria" here are implicitly tied to demonstrating performance equivalent to the predicate device in key imaging characteristics and a general review by an expert for clinical images.

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

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (1417WCA vs. 1417PCA)
Non-Clinical Performance:
Modulation Transfer Function (MTF) equivalence: MTF of 1417WCA should be substantially equivalent to 1417PCA.	Reported: "The comparison of the MTF for 1417WCA and 1417PCA detector demonstrated that the MTF of the 1417WCA detector performed almost same with 1417PCA. Therefore the overall resolution performance and sharpness of 1417WCA is almost same with 1417PCA."
Detective Quantum Efficiency (DQE) equivalence: DQE of 1417WCA should be substantially equivalent to 1417PCA.	Reported: "1417WCA demonstrated almost same DQE performance with 1417PCA 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 DQE test for 1417WCA and 1417 PCA resulted 74%, respectively."
Noise Power Spectrum (NPS) equivalence: NPS of 1417WCA should be substantially equivalent to 1417PCA.	Reported: "The NPS test for 1417WCA and 1417 PCA exhibited almost identical performance between the two devices."
Overall Image Quality (Non-Clinical): Image quality of 1417WCA should be substantially equivalent to 1417PCA at the same patient exposure setting.	Reported: "Therefore, the image quality of 1417WCA is substantially equivalent to 1417PCA at the same patient exposure setting."
Clinical Performance:
Clinical Image Quality equivalence: Clinical images from 1417WCA should be comparable to 1417PCA as determined by expert review.	Reported: "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 1417WCA and its predicate device, 1417PCA in terms of image quality." (Specific metrics or thresholds for "comparable" are not provided, as it relies on expert opinion).
Safety and EMC: Conformance to relevant electrical, mechanical, environmental and electromagnetic compatibility standards.	Reported: "Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1:1988 + A1:1991 + A2:1995... and EMC testing were conducted in accordance with standard IEC60601-1-2:2007... 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."

2. Sample size used for the test set and the data provenance:

Non-Clinical Test Set: The text mentions "non-clinical test report... prepared and submitted to FDA separately to demonstrate the substantial equivalency between two different detectors." It states the MTF, DQE, and NPS tests were conducted "by using the identical test equipment and same analysis method described by IEC 62220-1." While it doesn't give a specific number of images or runs, these tests typically involve standardized phantoms and measurement methodology, not patient data.
Clinical Test Set: Clinical images were obtained from "both devices" (1417WCA and 1417PCA). It also states "both the test (1417WCA) and control group (1417PCA) are evaluated according to similar age group and anatomical structures." The specific number of clinical images (sample size) is not provided.
Data Provenance: The document does not explicitly state the country of origin or whether the clinical data was retrospective or prospective.

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

Number of experts: "a licensed US radiologist" (singular) was used.
Qualifications: "a licensed US radiologist." No specific years of experience or specialty were detailed beyond "US radiologist."

4. Adjudication method for the test set:

The text describes a "comparative review by an expert." It does not specify a formal adjudication method like 2+1 or 3+1. The single radiologist provided an "expert opinion" on the clinical images.

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 MRMC study was performed. This submission is for a digital flat panel X-ray detector itself, not an AI/CADe system. The clinical evaluation involved a single radiologist performing a comparative review of images from the new device and the predicate device for substantial equivalence, not assessing human performance with or without AI.

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

Not applicable. This device is an imaging hardware component (digital flat panel X-ray detector), not an algorithm or AI system. Its "standalone" performance is characterized by physical imaging metrics like MTF, DQE, and NPS.

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

For the non-clinical tests (MTF, DQE, NPS), the ground truth is derived from physical measurements using standardized phantoms and test methods (IEC 62220-1).
For the clinical image comparison, the ground truth for establishing "substantial equivalency in terms of image quality" was based on the expert opinion/review of a single licensed US radiologist. It's not explicitly stated that they were looking for specific pathologies or outcomes, but rather overall diagnostic image quality comparison.

8. The sample size for the training set:

Not applicable. This device is a hardware detector and does not use a "training set" in the context of machine learning or AI algorithms. Its performance is inherent to its physical design and manufacturing.

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

Not applicable. As stated above, there is no training set for this hardware device.

Summary

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K130935
Page 1 of 5
Rev. 3

510(k) Summary

JUL 0 2 2013

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: March 26, 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:	1417WCA
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	: 1417PCA
510(k) Number	: K122919 (Decision Date - JAN. 31. 2013)

Device Description :

Indication for use :

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

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

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Characteristic	ProposedRayence Co.,Ltd.1417WCA	PredicateRayence Co.,Ltd.1417PCA
510(k) number	-	-K122919
Intended Use	1417WCA 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.	1417PCA 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	Cesium Iodide	Cesium Iodide
Imaging Area	14 x 17 inches	14 x 17 inches
Total PixelNumber	3328 x 2816 pixels	3328 x 2816 pixels
Pixel pitch	127 µm	127 µm
Resolution	3.9 lp/mm	3.9lp/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

Table 1: Comparison of 1417WCA and 1417PCA

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Weight	3.9 kg (incl. battery pack)	3.6 kg
Application	Wireless portable systemAvailable with upright stand,table, universal stand	Portable systemAvailable with upright stand,table, universal stand
Feature	Image: X-ray detector with handle on top	Image: X-ray detector with handle on top and crosshair in the center

Table 2: Size Comparison of 1417WCA and 1417PCA

Item	Unit	1417WCA	1417PCA
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	3.9 Kg	3.6 Kg

Summary of Performance Testing:

The wireless/wired 1417WCA flat panel detector is a modified version of 1417PCA (K122919), FDA cleared predicate device from Rayence. Indications for use, material, form factor, performance, and safety characteristics between 1417WCA and 1417PCA 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 1417WCA and 1417PCA by using the identical test equipment and same analysis method described by IEC 62220-1 The comparisoin of the MTF for 1417WCA and 1417PCA detector demonstated that the MTF of the 1417WCA detector performed almost same with 1417PCA. Therefore the overall resolution performance and shapness of 1417WCA is almost same with 1417PCA. The DQE represents the ability to visualize object details of a certain size and contrast. 1417WCA demonstrated almost same DQE

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performance with 1417PCA at various spatial frequencies and provides almost same Signal-toNoise Ratio (SNR) transfer from the input to the output of a detector as a function of frequency. At the lowest spatial frequency, the DQE test for 1417WCA and 1417 PCA resulted 74%, respectively. The NPS test for 1417WCA and 1417 PCA exhibited almost identical performance between the two devices. Therefore, the image quality of 1417WCA is substantially equivalent to 1417PCA at the same patient exposure setting.

To further demonstrate the substantial equivalency of two devices, clinical images are obtained from both devcies and reviewd by a licensed US radiologist to render an expert opinion. Both the test (1417WCA) and control group (1417PCA) 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 1417WCA and its predicate device, 1417PCA 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 1417WCA is safe and effective and substantially equivalent in comparison with 1417PCA, the predicate device as described herein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20003-0002

July 2. 2013

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

Re: K130935

Trade/Device Name: Digital Flat Panel X-ray Detector / 1417WCA Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: April 04, 2013 Received: April 04, 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 Mav 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 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 - Mr. Kim

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/ResourcesforYou/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,

Janning M. Menge

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): K130935

Device Name: Digital Flat Panel X-ray Detector / 1417 WCA

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)

Stamford M. Weiss

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

510(k) K 130935

Page 1 of

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.