1717SGC 127um and 1717SGC 140um are 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

1717SGC 127um X-ray detector is identical to 1717SGC (K122182). Both 1717SGC 127um and 1717SGC 140um are digital solid state X-ray detectors based on flat-panel technology. These radiographic image detectors and processing unit consist of a scintillator coupled to an a-Si TFT sensor. Both devices are connected to the user PC via wired LAN (ethernet cable) and need to be integrated with a radiographic imaging system. Both devices do not operate as an X-ray generator controller but can be utilized to convert X-ray to light and light to electrical signals for image data digitization.

The RAW files can be further processed as DICOM compatible image files by separate console SW (K160579 / Xmaru View V1 and Xmaru PACS/ Rayence Co.,Ltd.) for a radiographic diagnosis and analysis.

AI/ML Overview

This document describes a 510(k) premarket notification for the Rayence 1717SGC_127um and 1717SGC_140um digital flat panel X-ray detectors. The submission aims to demonstrate substantial equivalence to predicate devices, namely 1717SGC (K122182) and 1717SGN (K150150).

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal table of defined acceptance criteria with numerical thresholds. Instead, it relies on comparative performance against predicate devices and qualitative assessments.

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (1717SGC 140µm vs. Predicate 1717SGN)
Intended Use	Same as predicate device (general radiography for human anatomy, not mammography).	Met: "same indications for use"
Material / Form Factor / Safety	Similar to predicate devices.	Met: "same... material, form factor, performance, and safety characteristics"
Non-clinical Performance (MTF, DQE, NPS)	Performance at least equivalent to, or better than, the predicate device (1717SGN), based on IEC 62220-1.	Met: "performed better compared with each respective predicate device." "1717SGC 140um has higher MTF and DQE performance at high spatial frequencies, especially from 2 lp/mm." "The comparison of the MTF and DQE for 1717SGC 140um detector demonstrated that the performed almost same with 1717SGN."
Clinical Image Quality	Images from the subject device should be diagnostically equivalent, or superior, to those from the predicate device.	Met: "images obtained with the 1717SGC 140µm are superior to the same view obtained from a similar patient with the predicate devices, 1717SGN and 1717SCN." "soft tissues on extremity films were seen with better clarity. There is little difficulty in evaluating a wide range of anatomic structures necessary to provide a correct conclusion."
Electrical, Mechanical, Environmental Safety	Conformity to IEC 60601-1:2005 (3rd Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 and EMC testing to IEC 60601-1-2: 2007.	Met: "All test results were satisfactory."

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

Test Set Sample Size: The document does not specify a numerical sample size for the clinical images used in the expert review. It mentions "sample radiographs of similar age group and anatomical structures."
Data Provenance: The provenance of the clinical images (e.g., country of origin, retrospective or prospective) is not explicitly stated. The non-clinical test report refers to IEC 62220-1, which suggests standardized phantom-based testing, but doesn't specify data provenance for the clinical images.

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

Number of Experts: One expert was used for the clinical review: "reviewed by a licensed US radiologist to render an expert opinion."
Qualifications of Experts: The expert was a "licensed US radiologist." No specific experience (e.g., years) is provided.

4. Adjudication Method for the Test Set

Adjudication Method: None mentioned. As only one radiologist reviewed the images, there was no need for an adjudication process.

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

No, a MRMC study was not explicitly described. The clinical review was performed by a single licensed US radiologist comparing images from the subject device and the predicate.
Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as this device is a digital X-ray detector, not an AI-powered image analysis tool for human readers.

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

Yes, standalone performance was assessed for non-clinical metrics. MTF, DQE, and NPS tests were conducted "by using the identical test equipment and same analysis method described by IEC 62220-1." These are objective, quantitative measurements of the detector's image quality performance, independent of human interpretation for diagnostic purposes.

7. The Type of Ground Truth Used

Non-clinical Testing: The ground truth for MTF, DQE, and NPS is established by the standardized measurement methods defined in IEC 62220-1, using phantoms or controlled experimental setups.
Clinical Testing: The ground truth for clinical image quality assessment was based on expert opinion/consensus (though only one expert was involved). The radiologist's assessment of "better clarity" and "little difficulty in evaluating a wide range of anatomic structures" served as the basis for concluding diagnostic equivalence/superiority.

8. The Sample Size for the Training Set

Not Applicable. The document describes a medical device (X-ray detector) and its performance validation, not a machine learning or AI algorithm that requires a training set. The device itself is hardware that generates images.

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

Not Applicable. As there is no training set for an AI algorithm, there is no ground truth establishment for such a set.

Summary

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

June 9, 2017

Rayence Co., Ltd % Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway Houston, Texas 77025

Re: K171419

Trade/Device Name: 1717SGC 127um and 1717SGC 140um Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MOB Dated: May 1, 2017 Received: May 15, 2017

Dear Dave 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

Michael D. O'Hara
For

Robert A. Ochs. Ph.D. 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)

Device Name

1717SGC_127um and 1717SGC_140um

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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1. 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: June 7, 2017

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

Submitter's Name :	Rayence Co., Ltd.
Submitter's Address:	14, Samsung 1ro 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)
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:	1717SGC_127µm and 1717SGC_140µm
Common Name	: Digital Flat Panel X-ray Detector
510(k) Number	: K171419
Regulation Number	: 21 CFR 892.1680
Regulation Name	: Stationary X-ray System
Product Code	: MQB
Trade/Device Name	: 1717SGN / 1717SCN
Common Name	: Digital Flat Panel X-ray Detector
510(k) Number	: K150150 (Decision Date – March 27. 2015)
Regulation Number	: 21 CFR 892.1680
Regulation Name	: Stationary X-ray System
Product Code	: MQB

Rayence Co., Ltd.

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Reference Device :

Device	: 1717SGC
510(k) Number	: K122182
Common Name	: Digital Flat Panel X-ray Detector
Regulation Number	: 21 CFR 892.1680
Regulation Name	: Stationary X-ray System
Product Code	: MQB

2. Device Description :

The RAW files can be further processed as DICOM compatible image files by separate console SW (K160579 / Xmaru View V1 and Xmaru PACS/ Rayence Co.,Ltd.) for a radiographic diagnosis and analysis.

3. Indication for use

4. Summary of the Design Control Risk management:

1717SGC 127um X-ray detector is identical to 1717SGC (K122182). 1717SGC 140um digital X-ray detector is a modification of 1717SGN (K150150). 1717SGC 140um was developed for the purpose of retrofitting the stationary X-ray system with a film detector. 1717SGC 127um and 1717SGC 140um are connected to a PC with an ethernet cable.

The risks and the hazardous impact of the device modification were analyzed with FMEA method. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented in the new product design phase. The overall assessment concluded that all risks and hazardous conditions identified arising from the design change were successfully mitigated and accepted.

Rayence Co., Ltd.

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

Both 1717SGC_127um and 1717SGC_140um detectors described in this 510(k) have the same indications for use and similar technical characteristics as its predicate device, 1717SGN / (K150150) flat panel detector, of Rayence Co., Ltd

5.1 Scintillator layer

scintillator layer. ( * scintillator : a phosphor that produces scintillations)

	Proposed	Predicate
Gd₂O₂S:Tb(Gadolinium Oxysulfide)	1717SGC_127µm1717SGC_140 µm	1717SGN

5.2 Dimensions and Weight

		Proposed1717SGC	Predicate1717SGN / 1717SCN
Detector	Model name	1717SGC_127μm1717SGC_140 μm	1717SGN / 1717SCN
	W x L x H	460 X 460 X 15.5	460 X 460 X 15.5
	Weight	4 kg	4 kg
	Power supply	Model name	RS1717
W x L x H		188 X 92 X 41.5	188 X 92 X 41.5
Weight		0.5 kg	0.5 kg

5.3 Power Requirements (Power supply)

		Proposed1717SGC	Predicate1717SGN / 1717SCN
Powersupply	Model name	RS1717	RS1717
	W x L x H	AC 100 - 240 V~,50/60Hz	AC 100 - 240 V~,50/60Hz

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5.4 Proposed Labeling

Image /page/6/Figure/2 description: The image shows two tables comparing labels for 'Proposed 1717SGC' and 'Predicate 1717SGN / 1717SCN' devices. The first row of the table shows labels for a detector, with details like the manufacturer, model number (1717SGC or 1717SGN), ratings (24V or 24Vm, 1.90A), compliance certifications (CE0120, IEC 60601-1), and manufacturing information. The second row shows labels for a power supply, with details like the model number (RS1717), input/output specifications (100-240V, 24Vm, 1.90A), and fuse information (X2 T3. 15 AL 250 V).

5.5 Recommended Generator Specification

Model	Manufacture	Specification
		32kW	40kW	50kW
CMP 200	Communications & PowerIndustries	kVp	40-125	40-150
		mA	10-400	10-500	10-630
EDITOR HFe 501	Rontgenwerk Bochum	kVp	40-150
		mA	10-630
UD150L-40E/40F	Shimadzu	kVp	40-150
		mA	@100 kVp- 500(320)@80 kVp- 630(400)
PXR-321B	Poskom Co.,Ltd.	kVp	125/150
		mA	500

Image /page/6/Picture/5 description: The image shows a caution sign. The sign is a yellow triangle with a black border. Inside the triangle is a black exclamation point. Below the triangle is the word "CAUTION" in black, bold letters.

To our best knowledge, the detector is compatible with the X-ray generators with the specifications described above. If you have questions regarding the compatibility issue for other generators which are not listed above, please contact your Rayence representative.

This information will be included in user/installation documents for the end user.

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5.6 Comparison table

Characteristic	Proposed1717SGC	Predicate1717SGN / 1717SCN
510(k) number		K150150
Intended Use	1717SGC_127µm and1717SGC_140µm are indicated fordigital imaging solution designed forgeneral radiographic system forhuman anatomy. It is intended toreplace film or screen basedradiographic systems in all generalpurpose diagnostic procedures. Notto be used for mammography.	1717SGN and 1717SCN Digital Flat Panel X-Ray Detector is indicated for digital imagingsolution designed for general radiographicsystem for human anatomy. It is intended toreplace film or screen based radiographicsystems in all general purpose diagnosticprocedures. Not to be used for mammography.
Manufacturer	Rayence Co., Ltd.	Rayence Co., Ltd.
Detector Type	Amorphous Silicon, TFT	Amorphous Silicon, TFT
Scintillator	1717SGC_127µm1717SGC_140 µmGd2O2S:Tb	1717SGN Gd2O2S:Tb1717SCN CSI:T1
Imaging Area	17 x 17 inches	17 x 17 inches
Pixel matrix	127 type : 3328 x 3328140 type : 3072 x 3072	3072 x 3072
Pixel pitch	127 μm / 140 μm	139 μm
Resolution	3.9 lp/mm	3.9 lp/mm
A/D conversion	14 bit for 127 type / 16 bit for 140 type	14 / 16 bit
Preview time	≤2	≤2
Data output	RAW*The RAW files are convertible intoDICOM 3.0 by console S/W	RAW*The RAW files are convertible into DICOM3.0 by console S/W
Dimensions	460 × 460 × 15.5 mm	460 × 460 × 15.5 mm
Weight	4 kg	4 kg
Application	General Radiology system or PortablesystemAvailable with upright stand, table,	General Radiology system or Portable systemAvailable with upright stand, table, universalstand.

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6. Summary of Performance Testing:

1717SGC 127um X-ray detector is identical to 1717SGC (K122182). 1717SGC 127um and 1717SGC 140um Digital Flat Panel X-Ray Detectors have the same indications for use, material, form factor, performance, and safety characteristics compared to the predicate devices, 1717SGN.

1717SGC 140um is almost identical to 1717SGN (K150150) including the scintillator type (both Gd2O2S:Tb), maging area (17x17), pixel matrix (3072 x 3072), and resolution (3.9lp/mm).

The difference between two devices is the pixel pitch; 140 um vs 139um, respectively. It is minor and does not raise new concerns for the safety and effectiveness of the subject device.

The non-clinical test report and clinical consideration report for each subject device were prepared and submitted to FDA separately to demonstrate the substantial equivalency of the subject devices compared to each respective predicate device. The non-clinical test report contains the MTF, DQE and NPS test results of 1717SGC 140μm by using the identical test equipment and same analysis method described by IEC 62220-1.

The comparative result of the MTF and DQE test for 1717SGC 140um detector with respect to each respective predicate demonstrated that the MTF and DQE of the both subject devices performed better compared with each respective predicate device. The MTF and DQE represents the ability to visualize object details of a certain size and contrast. 1717SGC 140um has higher MTF and DOE performance at high spatial frequencies, especially from 2 lp/mm. The comparison of the MTF and DQE for 1717SGC 140um detector demonstrated that the performed almost same with 1717SGN.

To further demonstrate the substantial equivalency of two devices, clinical images are taken from both subject devices and reviewed by a licensed US radiologist to render an expert opinion. Both the test subject, 1717SGC 140μm and the predicate device,1717SGN, have been evaluated and compared by taking sample radiographs of similar age group and anatomical structures in accordance with the test protocol of diagnostic radiography evaluation procedure.

After a broad review of plain radiographic images taken with the 1717SGC 140um, the images obtained with the 1717SGC 140µm are superior to the same view obtained from a similar patient with the predicate devices, 1717SGN and 1717SCN. In general, both the spatial and soft tissue contrast resolution are superior using the 1717SGC 140μm. Specifically, the soft tissues on extremity films were seen with better clarity. There is little difficulty in evaluating a wide range of anatomic structures necessary to provide a correct conclusion.

Rayence Co., Ltd.

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Based on the non-clinical and clinical consideration test and the outcome of a comparative review by an expert for both devices, the sponsor can claim the substantial equivalency between the subject devices and their predicate devices in terms of diagnostic image quality.

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

7. Summary for any testing in the submission:

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1:2005 (3rd Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (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.

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

All test results were satisfactory.

8. 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 1717SGC 127um and 1717SGC 140um are safe and effective and substantially equivalent in comparison with the predicate devices.

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.