910SGA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy including head, neck, spinal column, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health professionals. Not to be used for mammography.

Device Description

910SGA is a digital solid state X-ray detector that is based on flat-panel technology. 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

Here's a breakdown of the acceptance criteria and study information for the 910SGA Digital Flat Panel X-ray Detector, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, numbered list. Instead, it demonstrates substantial equivalence to a predicate device (1210SGA) through direct comparison of technical characteristics and performance metrics. The underlying acceptance is that the device must perform at least as well as, or be substantially equivalent to, the predicate device.

Characteristic	Acceptance Criteria (Predicate Device K113630: 1210SGA)	Reported Device Performance (910SGA)	Meets Criteria?
Intended Use	Digital imaging for human anatomy (head, neck, spinal column, arm, leg, peripheral); replaces film-based systems for diagnosis and treatment planning; not for mammography.	Digital imaging for human anatomy (head, neck, spinal column, arm, leg, peripheral); replaces film-based systems for diagnosis and treatment planning; not for mammography. (Identical wording used)	Yes
Detector Type	Amorphous Silicon with TFT	Amorphous Silicon with TFT	Yes
Scintillator	Gadolinium Oxysulfide	Gadolinium Oxysulfide	Yes
Pixel Pitch	127 x 127 μm	127 x 127 μm	Yes
MTF (Resolution/Sharpness)	Equivalent to or better than 1210SGA	"The MTF of the 910SGA detector performed almost same with 1210SGA. Therefore the overall resolution performance and sharpness of 910SGA is almost same with 1210SGA."	Yes
DQE (Ability to Visualize Details)	Equivalent to or better than 1210SGA	"910GA demonstrated higher DQE performance than 1210GA 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, 910SGA has a DQE of 46% and that of 1210SGA is 45%." (Higher DQE is better)	Yes
NPS (Noise Performance)	Equivalent to or better than 1210SGA	"910SGA also exhibited NPS which has almost same performance with 1210SGA."	Yes
Clinical Image Quality	Substantially equivalent to 1210SGA	"Based on... the outcome of a comparative review by an expert for both devices, we can claim the substantial equivalency between 910SA and its predicate device, 1210SGA in terms of image quality."	Yes
Safety and Performance	Compliant with IEC 60601-1: 2005 + CORR.I(2006) + CORR(2007) and IEC 60601-1-2:2007, Class A.	"Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1: 2005 + CORR.I(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, Class A. All test results were satisfactory."	Yes

2. Sample Size and Data Provenance (Test Set):

Sample Size: The document does not specify an exact number of images or cases used for the clinical assessment. It states, "clinical images are taken from both devices" and implies a "sample radiographs of similar age groups and anatomical structures." This suggests a comparative, rather than quantitative, sample size.
Data Provenance: Not explicitly stated, but the submission is for a Korean company (Rayence Co., Ltd.) seeking FDA clearance, and the expert is a "licensed US radiologist." This suggests the clinical images could have been taken in the US or in Korea and reviewed by a US expert. The document does not specify if the images were retrospective or prospective.

3. Number of Experts and Qualifications (Ground Truth for Test Set):

Number of Experts: "a licensed US radiologist" (singular).
Qualifications: "licensed US radiologist." No specific years of experience are mentioned, but "licensed" implies significant training and qualification.

4. Adjudication Method (Test Set):

Method: Not explicitly stated as a formal adjudication method (like 2+1 or 3+1). The text mentions a "comparative review by an expert for both devices" and an "expert opinion." This implies a single expert's assessment without a formal multi-reader adjudication process described.

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

Was it done?: No, an MRMC comparative effectiveness study involving human readers with vs. without AI assistance was not explicitly stated or performed. This study focused on the performance of the new device (910SGA) compared to a predicate device (1210SGA), not on the impact of AI assistance on human readers. The device itself is a flat panel detector, not an AI algorithm for image interpretation.

6. Standalone (Algorithm Only) Performance:

Was it done?: This is not applicable in the context of this submission. The device is a digital flat panel X-ray detector, an imaging hardware component, not an AI algorithm. The performance evaluation focuses on the detector's image acquisition capabilities (MTF, DQE, NPS, and overall image quality for diagnosis) as compared to a predicate device.

7. Type of Ground Truth Used (Test Set):

Type: Clinical images were reviewed by an expert to render an "expert opinion" on image quality and "substantial equivalency." This falls under expert consensus/opinion rather than pathology or outcomes data. The goal was to confirm the diagnostic quality of the images produced by the device, not to diagnose specific diseases.

8. Sample Size for the Training Set:

Sample Size: The document does not refer to a "training set" in the context of machine learning or AI. The testing described is for a hardware device (X-ray detector). The "comparison" is between the proposed device and its predicate, using physical and clinical tests.

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

Method: Not applicable, as there is no mention of a "training set" for an AI algorithm. The testing relates to fundamental imaging performance and clinical image quality comparison of a hardware device.

Summary

{0}------------------------------------------------

K133409
page 1 of 5
Rev.0

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: November 5th, 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 / +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:	910SGA
Common Name:	Digital Flat Panel X-ray Detector
Classification Name :	21CFR892.1680 / Stationary x-ray system
Product Code:	MQB

{1}------------------------------------------------

Predicate Device :

Manufacturer	: Rayence Co., Ltd.
Device	: I210SGA
510(k) Number	: K113630 (Decision Date - DEC. 29. 2011)

Device Description :

Indication for use :

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

The 910SGA SSX1 detector described in this 510(k) has the same indications for use and similar technical characteristics as its predicate device. 1210SGA flat panel detector, of Rayence Co., Ltd. Table I summarizes the technological characteristics of the 910SGA and 1210SGA, the predicate device.

{2}------------------------------------------------

	Proposed	Predicate
Characteristic	Rayence Co.,Ltd.910SGA	Rayence Co.,Ltd.1210SGA
510(k) number	-	K113630
Intended Use	910SGA Digital Flat Panel X-RayDetector is indicated for digitalimaging solution designed forhuman anatomy including head,neck, spinal column, arm, leg andperipheral (foot, hand, wrist,fingers, etc.). It is intended toreplace film based radiographicdiagnostic systems and provide acase diagnosis and treatmentplanning for physicians and otherhealth professionals. Not to beused for mammography.	1210SGA Digital Flat Panel X-RayDetector is indicated for digitalimaging solution designed forhuman anatomy including head,neck, spinal column, arm. leg andperipheral (foot, hand, wrist.fingers, etc.). It is intended toreplace film based radiographicdiagnostic systems and provide acase diagnosis and treatmentplanning for physicians and otherhealth professionals. Not to be usedfor mammography.
Detector Type	Amorphous Silicon with TFT	Amorphous Silicon with TFT
Scintillator	Gadolinium Oxysulfide	Gadolinium Oxysulfide
Imaging Area	9x 10 inches	11 x 13 inches
Total PixelMatrix	2048 x 1792 pixels	2560 x 2080 pixels
Pixel pitch	127 \n- the

Table 1: Comparison of 910SGA and 1210SGA

{3}------------------------------------------------

Weight	2.0 kg	3.0 kg
Application	adults and pediatric care	adults and pediatric care
Feature	Image: flat square detector	Image: detector with raised edges

Table 2: Size Comparison of 910SGA and 1210SGA

Item	Unit	910SGA	1210SGA
Pixel Pitch	μm	127 x 127	127 x 127
Total Pixel Matrix	pixels	2048 x 1792	2560 x 2080
Total Pixel Area	mm	260.1 x 227.6	264 x 325
Effective Pixel Matrix	pixels	2008 x 1752	2520 x 2040
Fill factor	%	61.03	65.14
Weight	Kg	2.0 Kg	3.0 Kg

Summary of Performance Testing:

The 910SGA flat panel detector is a modified version of 1210SGA (K113630), FDA cleared predicate device from Rayence. Indications for use, material, form factor, performance, and safety characteristics between 910SGA and 1210SGA 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 non-clinical test report contains the MTF, DQE and NPS test results of 910SGA and 1210SGA by using the identical test equipment and same analysis method described by IEC 6220-1 The comparison of the MTF for 910SGA and 1210SGA detector demonstrated that the MTF of the 910SGA detector performed almost same with 1210SGA. Therefore the overall resolution performance and sharpness of 910SGA is almost same with 1210SGA. The DQE represents the ability to visualize object details of a certain size and contrast. 910GA demonstrated higher DQE performance than 1210GA 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, 910SGA has a DQE

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows a handwritten document with the text "K133409 Page 5 of 5 Rev 0". The text appears to be a page number and revision number for a document. The handwriting is cursive and slightly stylized.

of 46% and that of 1210SGA is 45%. 910SGA also exhibited NPS which has almost same performance with 1210SGA. Therefore, the image quality of 910SGA is found to be substantially equivalent to 1210SGA 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 (910SGA) and control group (1210SGA) 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.

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 910SA and its predicate device, 1210SGA in terms of image quality.

Summary for any testing in the submission

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1: 2005 + CORR.I(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, Class A.

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

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

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 910SGA is safe and effective and substantially equivalent in comparison with 1210SGA, the predicate device as described herein.

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

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

February 21, 2014

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

Re: K133409

Trade/Device Name: Digital Flat Panel X-ray Detector/ 910sga Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: January 17, 2014 Received: January 23, 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, 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.

{6}------------------------------------------------

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

hun://www.lda.gov/MedicalDevices/Resourcesfor You/Industry/detault.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2) 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/Safetv/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,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133409

Device Name 910SGA Digital Flat Panel X-Ray Detector

Indications for Use (Describe)

910SGA Digital Flat Panel X-Ray Detector is indical imaging solution designed for human anatomy including head, neck, spinal column, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health professionals. Not to be used for mammography.

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

[x] Prescription Use (Part 21 CFR 801 Subpart D)

O 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) (Signature)	Smi

	Page 1 of 2

FORM FDA 3881 (6/13)

F.W. Woolworth Co. (1,111.61)

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

{8}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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.