1717SCC 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

1717SCC 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 an analysis of the provided 510(k) summary regarding the 1717SCC device, focusing on acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (Xmaru1717) rather than defining specific, numerical acceptance criteria for all performance metrics. However, based on the comparative performance study, we can infer implied acceptance criteria related to equivalent or improved diagnostic image quality.

Acceptance Criteria (Implied from Substantial Equivalence to Predicate)	Reported Device Performance (1717SCC vs. Xmaru1717)
Diagnostic Image Quality (Clinical)	Equivalent or Better: Clinical images taken from both devices (1717SCC and Xmaru1717) were reviewed by a licensed US radiologist. Based on this expert review across age groups and anatomical structures, the submission claims "equivalent or better diagnostic image quality for 1717SCC compared to the predicate device, Xmaru1717."
Modulation Transfer Function (MTF)	Lower but Offset by Smaller Pixel Size: The MTF of the Xmaru1717 detector performed better initially than 1717SCC. However, the smaller pixel size (127 µm vs. 143 µm) and a new bonding mechanism in 1717SCC are stated to result in "overall resolution performance and sharpness of 1717SCC is better than Xmaru1717 which results improvement of the ability of the new detector to represent distinct anatomic features within the imaged object." (Implied acceptance: overall resolution/sharpness is at least equivalent or better).
Detective Quantum Efficiency (DQE)	Better Performance at Various Spatial Frequencies (but lower at zero-frequency): 1717SCC demonstrated better DQE performance than Xmaru1717 at various spatial frequencies, providing a higher Signal-to-Noise Ratio (SNR) transfer. The zero-frequency DQE values were lower for 1717SCC (0.223) than Xmaru1717 (0.38), but this is associated with "reduced noise" and "improved accuracy of image and reduced the degree of artifacts for the new detector." (Implied acceptance: overall DQE/SNR transfer is improved or equivalent for diagnostic purposes).
Noise Power Spectrum (NPS)	Lower Performance: 1717SCC exhibited NPS which has lower performance than Xmaru1717. However, this is presented in the context of the "reduced noise" mentioned with DQE, and ultimately contributing to the claim that "the image quality of 1717SCC is greater than Xmaru1717 at the same patient exposure." (Implied acceptance: acceptable noise characteristics that do not degrade diagnostic image quality, or even enhance it in conjunction with other factors).

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

Sample Size: Not explicitly stated for the clinical image comparison. The description mentions "clinical images are taken from both devices" and evaluated "according to age group and anatomical structures." The specific number of images or cases is not provided.
Data Provenance: The images were "taken from both devices" (1717SCC and Xmaru1717). The clinical review was performed by a "licensed US radiologist," implying the data was relevant to clinical practice, but doesn't specify if it was retrospective or prospective. Given the nature of a 510(k) for a detector, it's highly probable these were retrospective comparisons of images acquired using the two devices rather than a lengthy prospective clinical trial.
Non-Clinical Test Set: For MTF, DQE, and NPS, standard phantoms and methodologies (IEC 6220-1) were used. These are simulated test conditions, not patient data in the same sense as clinical images.

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 further details on years of experience or subspecialty are provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/None, as only one expert was used for the clinical image review. This was a single-reader assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not reported. The clinical review was performed by a single radiologist. Therefore, no effect size of human readers improving with AI vs. without AI assistance can be determined from this submission, as AI assistance in the interpretation itself is not described (this is a detector, not an AI image analysis tool). The "AI" in this context refers to the technological advancements in the detector itself.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in the sense of non-clinical performance metrics. The non-clinical tests (MTF, DQE, NPS) are standalone evaluations of the detector's physical performance characteristics, independent of human interpretation. These metrics were compared between the new device and the predicate. The device itself is a digital flat panel detector, not an image analysis algorithm that provides automated interpretations.

7. The Type of Ground Truth Used

For Clinical Image Review: Expert consensus was not used as only one radiologist reviewed. It was based on expert opinion/qualitative assessment by a single licensed US radiologist, comparing the diagnostic image quality of images acquired with the 1717SCC against those from the predicate device (Xmaru1717). The "ground truth" was essentially the subjective judgment of diagnostic equivalence or superiority by the single expert.
For Non-Clinical Performance: Objective, quantitative measurements against established physics standards (IEC 6220-1) for MTF, DQE, and NPS.

8. The Sample Size for the Training Set

The device is a digital X-ray detector, not an AI or machine learning algorithm in the typical sense that requires a "training set" of data for learning patterns. It is a hardware device. Therefore, the concept of a training set as understood for AI software does not apply directly here. The "training" for such a device would be its engineering design and manufacturing process.

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

As explained above, there isn't a "training set" or "ground truth for a training set" in the context of an AI algorithm for this hardware device. The device's performance characteristics are inherent to its design and components (scintillator, a-Si TFT sensor, pixel pitch, etc.).

Summary

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K122173

510(k) Submission – 1717SCC

Special 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: August 31st, 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 Iro gil,Hwaseong-Si, Gyeonggi-Do, 445-170,Republic of 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:	1717SCC
Common Name:	Digital Flat Panel X-ray Detector
Classification Name :	21CFR 892.1650, Solid State X-ray Imaging Device, Class2
Product Code:	MQB

Rayence Co., Ltd.

OCT 1 9 2012

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510(k) Submission - 1717SCC

Predicate Device :

SIOS : Manufacturer Device 510(k) Number

: Rayence Co.,Ltd. : Xmaru1717 : K091090 (Decision Date - SEP 9. 2010)

Device Description :

Indication for use :

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

The 1717SCC SSXI detector described in this 510(k) has the same indications for use and similar technical characteristics as its predicate device, Xmaru1717, of Rayence Co., Ltd. Table 1 summarizes the technological characteristics of the 1717SCC and Xmaru1717 the predicate device.

Characteristic	ProposedRayence Co.,Ltd.1717SCC	PredicateRayence Co.,Ltd.Xmaru1717
510(k) number	-	K091090
Intended Use	1717SCC 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.	Xmaru1717 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.
Detector Type	Amorphous Silicon, TFT	Amorphous Silicon, TFT
Scintillator	Cesium Iodide	Gadolinium Oxysulfide
Imaging Area	17 x 17 inches	17 x 17 inches
Pixel matrix	3328 x 3328 (10 million)	3072 x 3072 (9 million)
Pixel pitch	127 $\mu$ m	143 $\mu$ m
Resolution	3.9 lp/mm	3.5 lp/mm
A/D conversion	14 bit	14 bit
Grayscale	16384 (14bit)	16384 (14bit)
Preview Image	3~4 seconds	5 seconds per Image
Data output	RAW*The RAW files are convertible intoDICOM 3.0 by console S/W	RAW*The RAW files are convertible intoDICOM 3.0 by console S/W
Dimensions	460 × 460 × 15.9 mm	500 x 497 x 45 mm
Weight	5.3 kg	13.4 kg
Application	General Radiology system orPortable systemAvailable with upright stand, table,universal stand.	General Radiology system orPortable systemAvailable with upright stand, table,universal stand.

Table 1: Comparison of 1717SCC and Xmaru1717

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510(k) Submission - 1717SCC

Image /page/3/Picture/1 description: The image shows two different views of a flat panel detector. The left image shows the detector with a handle on top and a crosshair in the center of the panel. The right image shows a close up of the flat panel detector, with a white label on the side.

Table 2: Comparison of 1717SCC and Xmaru1717

Item	Unit	1717SCC	Xmaru1717
Pixel size	μm	127 x 127	143 x 143
Total horizontal andvertical size	mm	426 x 426	439 x 439
Total horizontal andvertical element count	pixels	3328 x 3328	3072 x 3072
Active area horizontal andvertical size	mm	426 x 426	429 x 429
Active area horizontal andvertical element count	pixels	3250 x 3250	3000 x 3000
Pixel spacing	um	127	143
Fill factor	%	63	68.30
Weight	Kg	5.3 Kg	13.4 Kg

Note: The weight of new sensor differs from the predicate sensor (Xmaru1717).

Change of the case material : The new sensor casing is done with stainless steel (lighter) instead of Aluminum (heavier). The result is approximately 5kg less weight for 1717 SCC detector compared with the Xmaru1717 detector, predicate device.
Panel : Unlike the new detector, the previous detector is bonded with the sub-glass panel, (the thickness of 2.9mm). The result is approximately 1.5kg less weight for 1717SCC.
Lighter Main BD Block(Structure between the Panel and Main BD) : Approximately 1kg less weight
Lighter Main BD : Approximately 0.7kg less weight

Summary of Performance Testing:

Indications for use, material, form factor, performance, and safety characteristics between 1717SCC and the predicate device are very similar. The primary difference is Pixel size, Pixel matrix, Pixel pitch, Resolution and Scintillator materials; Cesium iodide(CsI) for 1717SCC and GOS(Gd202S:Tb) for Xmaru1717, respectively. The non-clinical test report and clinical consideration report were prepared and submitted to FDA separately to demonstrate the substantial

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equivalency between two different detectors. The non-clinical test report contains the MTF, DQE and NPS test results of 1717SCC and Xmaru1717 by using the identical test equipment and same analysis method described by IEC 6220-1 The comparisoin of the MTF for 1717SCC and Xmaru1717 detector demonstated that the MTF of the Xmaru1717 detector performed better than 1717SCC. Nevertheless, the new detector 1717SCC utilizes a new bonding mechanism to narrow the gap between the panel and scintillator. Moreover, the pixel size of the new detector 1717SCC

is 127 um smaller than 143 um of Xmaru1717. Thereofre, the overall resolution performance and

shapness of 1717SCC is better than Xmaru1717 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. 1717SCC demonstrated better DQE performance than Xmarul 717 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 zero-frequency DQE values for 1717SCC is much lower than Xmaru1717; 0.223 and 0.38 respectively. The reduced noise has imporved the accuracy of image and reduced the degree of artifacts for the new detector. 1717SCC exhibited NPS which has lower performance than Xmaru1717. Therefore, the image quality of 1717SCC is greater than Xmaru1717 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 (1717SCC) and control group (Xmaru1717) 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 for1717SCC compared to the predicate device, Xmaru1717.

Safety, EMC and Performance Data :

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

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Electromagnetic Compatibility Requirements and tests) / EN 60601-1-2:2007. 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 1717SCC is safe and effective and substantially equivalent in comparison with the predicate device as described herein.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with a serpent entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and is in a sans-serif font.

Public Health Service

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

OCT 1 9 2012

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

Re: K122173

Trade/Device Name: Digital Flat Panel X-Ray Detector/1717SCC Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: July 13, 2012 Received: August 20, 2012

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/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/cdrh/industry/support/index.html.

Sincerely Yours,

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):

KI22)73

Device Name: Digital Flat Panel X-Ray Detector /1717SCC

Indications for Use:

1717SCC 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 o diagnostic procedures. Not to be used for mammography.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Page 1 of 1

Michael D'Ohm

(Division Sign Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

510(k) K122173

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.