1417PCA 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

1417PCA is a portable digital X-ray flat panel detector that can generate images of any part of the body. This X-ray imaging system consists of a scintillator directly coupled to an a-Si TFT sensor. It makes high-resolution, high-sensitive digital images. 1417PCA is designed specifically to be integrated with an operating PC and a X-ray generator to digitalize X-ray images into RAW files. The RAW files can be made to DICOM compatible image files for a radiographic diagnosis and analysis by console SW.

AI/ML Overview

The provided 510(k) summary describes the Rayence Co., Ltd. 1417PCA Digital Flat Panel X-ray Detector and its substantial equivalence to a predicate device. The information below is extracted and organized as requested.

Acceptance Criteria and Device Performance

The acceptance criteria for the 1417PCA device are established through comparison with the predicate device, SDX-4336CP, primarily focusing on superior or equivalent performance in key imaging metrics.

Table 1: Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Relative to Predicate SDX-4336CP)	Reported Device Performance (1417PCA)
MTF (Modulation Transfer Function)	Better than SDX-4336CP	Performed better than SDX-4336CP
DQE (Detective Quantum Efficiency)	Better than SDX-4336CP	Demonstrated better DQE performance (e.g., 55% at lowest spatial frequency vs. 52% for SDX-4336CP)
NPS (Noise Power Spectrum)	Lower performance (implies reduced noise)	Exhibited NPS with lower performance (implies reduced noise)
Image Quality (Overall)	Equivalent or better diagnostic image quality	Claimed equivalent or better diagnostic image quality

Study Information

2. Sample Size Used for the Test Set and Data Provenance:
The document states that "clinical images are taken from both devices." However, it does not specify the sample size for the test set (number of images or patients).
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The test set images were "reviewed by a licensed US radiologist to render an expert opinion." This indicates that one licensed US radiologist was used. The specific qualifications (e.g., years of experience, subspecialty) are not provided beyond being a "licensed US radiologist."

4. Adjudication Method for the Test Set:
The document mentions a single "licensed US radiologist" reviewing images and rendering an "expert opinion." This implies no formal adjudication method (e.g., 2+1, 3+1) was used, as it appears to be a solitary review.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not describe an MRMC comparative effectiveness study involving multiple readers and comparing performance with and without AI assistance to quantify an effect size. The clinical evaluation involved one radiologist comparing images from the proposed and predicate devices.

6. Standalone (Algorithm Only) Performance:
The device is a digital X-ray flat panel detector, not an AI algorithm. The performance evaluation is for the hardware's ability to acquire images. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable in the context of this device. The performance metrics like MTF, DQE, and NPS are intrinsic to the detector hardware.

7. Type of Ground Truth Used:
The ground truth for the clinical comparison was established by the expert opinion of a licensed US radiologist after reviewing clinical images from both devices. The images were evaluated based on age group and anatomical structures according to a diagnostic radiography evaluation procedure.

8. Sample Size for the Training Set:
The device described is a digital X-ray detector, which is hardware for image acquisition. It does not involve a "training set" in the context of machine learning algorithms. The performance evaluation focuses on the physical characteristics and image quality of the detector itself.

9. How the Ground Truth for the Training Set Was Established:
As there is no "training set" for this hardware device, this question is not applicable.

Summary

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K 122919

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: September. 21, 2012

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

Submitter's Name :	Rayence Co., Ltd.
Submitter's Address:	(Seogu-dong, 2F/4F) 14, Samsung 1ro 1-gil,Hwaseong-si, Gyeonggi-do, 445-170, Korea
Submitter's Telephone:	+82-31-8015-6459
Contact person:	Mr. Kee Dock Kim / Manager
Official Correspondent:(U.S. Designated agent)	Dave Kim (davekim@mtech-inc.net)
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:	1417PCA
Common Name:	Digital Flat Panel X-ray Detector
Classification Name :	Solid State X-ray Imaging Device, Class2
Regulation Number / Name:	21CFR 892.1680 / Stationary X-ray system

Rayence Co., Ltd.

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Product Code:	MQB
Predicate Device :
Manufacturer	: Samsung Mobile Display Co., Ltd.
Device	: SDX-4336CP
510(k) Number	: K102321 (Decision Date - Feb. 11. 2011)

Device Description :

Indication for use :

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

1417PCA SSXI detector described in this 510(k) has the same indications for use and similar technical characteristics as its predicate device, SDX-4336CP, of Samsung Mobile Display Co., Ltd. Table 1 summarizes the technological characteristics of the 1417PCA and SDX-4336CP the predicate device.

Characteristic	ProposedRayence Co.,Ltd.1417PCA	ProposedSamsung Mobile DisplayCo., Ltd.SDX-4336CP
510(k) number		K102321
Intended Use	1417PCA Digital Flat PanelX-Ray Detector is indicatedfor digital imaging solutiondesigned for generalradiographic system forhuman anatomy. It isintended to replace film orscreen based radiographicsystems in all generalpurpose diagnosticprocedures. Not to be usedfor mammography.	SDX-4336CP Digital Flat PanelX-Ray Detector is indicated fordigital imaging solution designedfor providing generalradiographic diagnosis of humananatomy targeting both adult andchildren. It is intended to be usedby physicians and radiologistsand 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
Pixel matrix	3328 x 2816 (9.4 million)	2880 x 2400 (6.9 million)
Pixel pitch	127 um	150 um
Resolution	3.9lp/mm	3.3lp/mm

Table 1: Comparison of 1417PCA and SDX-4336CP

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A/D conversion	14 bit	14 bit
Grayscale	16384 (14bit)	16384 (14bit)
Preview Image	2~3 seconds	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	491 × 480 × 15 mm
Weight	3.6 kg	3.8 kg
Application	Portable systemAvailable with upright stand,table, universal stand	Portable systemAvailable with upright stand,table, universal stand
Feature	Image: black box with handle	Image: gray box

Table 2: Comparison of 1417PCA and SDX-4336CP

Item	Unit	1417PCA	SDX-4336CP
Pixel size	μm	127 x 127	150 x 150
Total horizontal and vertical size	mm	422.7 x 357.6	432 x 360
Total horizontal and vertical element count	pixels	3328 x 2816	2880 x 2400
Active area horizontal and vertical size	mm	416.6 x 351.8	423 x 351
Active area horizontal and vertical element count	pixels	3280 x 2770	2820 x 2340
Pixel spacing	μm	127	150
Fill factor	%	65.14	68.5
Weight	Kg	3.6 Kg	3.8 Kg

Rayence Co., Ltd.

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Summary of Performance Testing:

Indications for use, material, form factor, performance, and safety characteristics between 1417PCA and the predicate device are very similar. 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 1417PCA and SDX-4336CP by using the identical test equipment and same analysis method described by IEC 6220-1 The comparisoin of the MTF for 1417PCA and SDX-4336CP detector demonstated that the MTF of the 1417PCA detector performed better than SDX-4336CP. Therfore the overall resolution performance and shapness of 1417PCA is better than SDX-4336CP which results improvement of the ability of the new detector to represent distinct anatomic features whitin the imaged object. The DQE represents the ability to visualize object details of a certain size and contrast. 1417PCA demonstrated better DQE performance than SDX-4336CP at various spatial frequencies and provides a higher Signal-toNoise Ratio (SNR) transfer from the input to the output of a detector as a function of frequency. At the lowest spatial frequency, 1417PCA has a DQE of 55% and that of SDX-4336CP is 52%. The reduced noise has imporved the accuracy of image and reduced the degree of artifacts for the new detector. 1417PCA exhibited NPS which has lower performance than SDX-4336CP. Therefore, the image quality of 1417PCA is greater than SDX-4336CP at the same patient exposure.

To further demonstrate the substantial equivalency of two devices, clinical images are taken from both devcies and reviewd by a licensed US radiologist to render an expert opinion. Both test (1417PCA) and control group (SDX-4336CP) are evaluated according to 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 and the outcome of an expert review of image comparisions for both devices, we can claim equivalent or better diagnostic image quality for1417PCA compared to the predicate device, SDX-4336CP.

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Safety, EMC and Performance Data :

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1:1998+A1:1999+A2:1995(Medical electrical equipment Part 1: General Requirements for Safety) was performed, and EMC testing were conducted in accordance with standard (Medical electrical equipment - Part 1-2: General Requirements for safety - Collateral Standard : Electromagnetic Compatibility Requirements and tests).

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.

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

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.

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

January 31, 2013

Ravence Co., LTD. C/O Mr. Dave Kim Medical Devices Regulatory Affairs Mtech Group 12946 Kimberley Lane HOUSTON TX 77079

Re: K122919

Trade/Device Name: Digital Flat Panel X-ray Detector 1417PCA Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: January 16, 2013 Received: January 28, 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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sean M. Boyd -S 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): K122919

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

Indications for Use:

Prescription Use X (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)

Sean M. Boyd -S

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

K122919 510(k)

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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.