1417WGC 127um and 1417WGC 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

While 1417WGC_127um digital X-ray detector is identical to 1417WGC (K141563), both 1417WGC 127um and 1417WGC 140um are wired/wireless digital solid state X-ray detectors which are based on flat-panel technology. The wireless LAN(IEEE 802.11a/g/n/ac) communication signals images captured to the system and improves the user operability through high-speed processing. 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. Both devices do not operate as an X-ray generator controller but both 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 (K160579 / Xmaru View V1 and Xmaru PACS/ Rayence Co.,Ltd.) for a radiographic diagnosis and analysis.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a digital flat panel X-ray detector. It describes the device, its intended use, and a comparison to a predicate device. The primary study presented here is a demonstration of substantial equivalence, which involves both non-clinical and clinical considerations rather than a strict acceptance criteria study against a specific performance metric.

Based on the provided text, here's an attempt to extract the requested information, acknowledging that specific "acceptance criteria" in numerical terms for clinical performance are not explicitly stated as they might be for an AI algorithm performance study. Instead, the equivalence to the predicate device is the key acceptance criterion.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion Type	Acceptance Criterion	Reported Device Performance
Non-Clinical
MTF (Modulation Transfer Function)	"performed similarly compared with the predicate devices"	"1417WGC_140um has similar MTF... performance at all spatial frequencies, especially from 2 lp/mm to 3.5 lp/mm. The comparison of the MTF... for 1417WGC_140um detector demonstrated that the performed almost same with 1417WGA."
DQE (Detective Quantum Efficiency)	"performed similarly compared with the predicate devices"	"...DQE of the both 1417WGA performed similarly compared with the predicate devices... The comparison of the... DQE for 1417WGC_140um detector demonstrated that the performed almost same with 1417WGA."
Clinical Equivalence	"demonstrate the substantial equivalency of the subject devices compared to each respective predicate device" in terms of diagnostic image quality.	"the images obtained with the 1417WGC 140um are superior to the same view obtained from a similar patient with 1417WGA, the predicate devices. In general, both the spatial and soft tissue contrast resolution are superior using the 1417WGC_140μm. Specifically, the soft tissues on extremity were seen with better clarity. There is little difficulty in evaluating a wide range of anatomic structures necessary to provide a correct conclusion."
Safety & Effectiveness	Device is "safe and effective and substantially equivalent"	"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."

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

Sample Size: The text states, "clinical images are taken from both subject devices and reviewed by a licensed US radiologist." However, it does not specify the exact number of images or cases in this clinical test set. It mentions "sample radiographs of similar age groups and anatomical structures."
Data Provenance: Prospective, as images were "taken from both subject devices" specifically for this comparison. The country of origin for the clinical data is implied to be the US ("reviewed by a licensed US radiologist").

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, implying one expert).
Qualifications of Experts: "licensed US radiologist." Specific years of experience are not mentioned.

4. Adjudication method for the test set

Adjudication Method: The text describes a "comparative review by an expert." This indicates a single expert opinion was used, performing a direct comparison between images from the subject device and the predicate device. There is no mention of consensus methods (e.g., 2+1, 3+1) or multiple readers.

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, a multi-reader, multi-case (MRMC) comparative effectiveness study as typically understood for AI-assisted reading was not conducted. This study compares a new imaging device (digital X-ray detector) to a predicate imaging device, not the effectiveness of human readers with or without AI assistance. Therefore, no effect size for human reader improvement with AI is provided.

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

Yes, partially. Non-clinical performance tests like MTF and DQE were performed on the device itself (algorithm/device only performance), comparing it to the predicate device. However, the "clinical consideration" involved a human radiologist for diagnostic image quality evaluation, meaning the overall clinical assessment was not purely standalone. The device itself is an image acquisition device, not an AI diagnostic algorithm, so "standalone performance" in the AI sense isn't directly applicable for the clinical evaluation.

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

For the clinical comparison, the ground truth was based on the expert opinion/impression of a licensed US radiologist regarding diagnostic image quality, specifically comparing the visibility of anatomic structures and clarity of soft tissues between images produced by the subject device and the predicate device.

8. The sample size for the training set

This document describes safety and effectiveness for a medical device (Digital Flat Panel X-ray Detector), not an AI algorithm that requires a training set. Therefore, there is no training set sample size mentioned or applicable in this context. The device's underlying technology (a-Si TFT sensor, scintillator) is hardware-based.

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

N/A, as there is no training set for an AI algorithm for this device.

Summary

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

June 12, 2017

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

Re: K171417

Trade/Device Name: 1417WGC 127um and 1417WGC 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)

K171417

Device Name

1417WGC_127um and 1417WGC_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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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 1-ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea
Submitter's Telephone:	+82-31-8015-6459
Contact person:	Mr. Kee Dock Kim / RA Team 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:	: 1417WGC_127µm and 1417WGC_140µm
Common Name	: Digital Flat Panel X-ray Detector
Regulation Number	: 21 CFR 892.1680
Regulation Name	: Stationary X-ray System
Product Code	: MQB
Predicate Device :
Device	:1417WGA
510(k) Number	: K131114
Common Name	: Digital Flat Panel X-ray Detector
Regulation Number	: 21 CFR 892.1680
Regulation Name	: Stationary X-ray System
Product Code	: MQB
Reference Device:

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Device	: 1417WGC (Manufactured by Rayence)
510(k) Number	: K141563
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

3. Indication for use

1417WGC_127um and 1417WGC_140µm 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.

4. Summary of Design Control Risk management

1417WGC_127um digital X-ray detector is identical to 1417WGC (K141563). 1417WGC_140um digital X-ray detector is a modification of 1417WGA (K131114) was developed for the purpose of ideal for inroom and portable imaging with a film detector. 1417WGC_140μm is slightly thinner and lighter than 1417WGA.

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.

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

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predicate device:

1417WGC_127μm digital X-ray detector is identical to 1417WGC (K141563). 1417WGC_140μm detector described in this 510(k) has the same indications for use and similar technical characteristics as its predicate device, 1417WGA.

5.1 Comparison table

Characteristic	ProposedRayence Co.,Ltd.1417WGC	PredicateRayence Co.,Ltd.1417WGA
Feature	Image: Rayence Co.,Ltd. 1417WGC	Image: Rayence Co.,Ltd. 1417WGA
510(k) number		K131114	Same
Intended Use	1417WGC_127µm and1417WGC_140µm are indicated fordigital imaging solution designed forgeneral radiographic system for humananatomy. It is intended to replace film orscreen based radiographic systems in allgeneral purpose diagnostic procedures.Not to be used for mammography.	1417WGA Digital Flat Panel X-RayDetector is indicated for digitalimaging solution designed for generalradiographic system for humananatomy. It is intended to replace filmor screen based radiographic systemsin all general purpose diagnosticprocedures. Not to be used formammography.	Same
Detector Type	Amorphous Silicon, TFT	Amorphous Silicon, TFT	Same
Scintillator	1417WGC_127µm1417WGC_140µm	1417WGA	Same
Imaging Area	14 x 17 inches	14 x 17 inches	Same
Pixel matrix	127 : 3328 X 2816140 : 3052 X 2500	3328 x 2816	Similar
Pixel pitch	127 µm / 140 µm	127 µm	Similar
Resolution	3.9 lp/mm	3.9 lp/mm	Same
A/D conversion	14 bit for 127 µm /16 bit for 140 µm	14 bit	Same
Preview time	≤2(wied / wireless)	2~~3 seconds (wired) / 3~~5 seconds(wireless)	Similar
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	Same
Dimensions	460 x 384 × 15 mm	460 x 417 × 15.9 mm	Similar
Weight	3.0 kg (incl. battery)	3.9 kg (incl. battery)	Similar
Application	General Radiology system orWireless/Wired portable system	Wireless portable system	Same
	Available with upright stand, table,universal stand.	universal stand
AddedOptionalComponents	Battery & Battery ChargerInterface BoxIrDA module	Battery & Battery Charger	Similar

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5.2 Scintillator layer

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

	Proposed	Predicate
Gd₂O₂S:Tb(Gadolinium Oxysulfide)	1417WGC_127μm1417WGC_140μm	1417WGA

5.3 Added Optional Components (Comparison with Predicate device)

Components	Description
Battery & Battery ChargerImage: Battery and Battery Charger	Sources of electricity.
Mobile Battery ChargerImage: Mobile Battery Charger
Interface BoxImage: Interface Box	1) Connector to synchronize the detector and generator.2) Data transfer and charging battery while detector is in use(Connect between detector and Interface Box), Up to three detectorcan be connected.3) Transmitting an image/command between the detector and PC.4) Wireless AP.
IrDA moduleImage: IrDA module	Sharing function for PC and detector.

5.4 Recommended Generator Specifications

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Model	Manufacture	Specification
CMP 200	Communications & PowerIndustries	32kW	40kW	50kW
		kVp	40-125	40-150
		mA	10-400	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)
		mA	@80 kVp- 630(400)
PXR-321B	Poskom Co.,Ltd.	kVp	125/150

6. Summary of Performance Testing

1417WGC_127μm digital X-ray detector is identical to 1417WGC (K141563). 1417WGC_140μm Digital Flat Panel X-Ray Detectors have the same indications for use, the same imaging area (14 x 17), based on the same scintillator material (Gd2O2S:Tb), the same resolution (3.9 lp/mm), performance, and safety characteristics compared to the predicate devices. The pixel pitch sizes are different but the differences do 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. DOE and NPS test results of 1417WGC 140um 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 1417WGC_140um detector with respect to the predicate device demonstrated that the MTF and DOE of the both 1417WGA performed similarly compared with the predicate devices. The MTF and DQE represents the ability to visualize object details of a certain size and contrast. 1417WGC_140um has similar MTF and DQE performance at all spartial frequencies, especially from 2 1p/mm to 3.5 lp/mm. The comparison of the MTF and DQE for 1417WGC_140um detector demonstrated that the performed almost same with 1417WGA.

To further demonstrate the substantial equivalency of two devices, clinical images are taken from both

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subject devices and reviewed by a licensed US radiologist to render an expert opinion. Both the test subject (1417WGC 140um) and the predicate devices (1417WGA) have been 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.

After a broad review of plain radiographic images taken with the 1417WGC 140um and 1417WGA, the images obtained with the 1417WGC 140um are superior to the same view obtained from a similar patient with 1417WGA, the predicate devices. In general, both the spatial and soft tissue contrast resolution are superior using the 1417WGC_140μm. Specifically, the soft tissues on extremity were seen with better clarity. There is little difficulty in evaluating a wide range of anatomic structures necessary to provide a correct conclusion.

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 1417WGC_127um and 1417WGC_140um are safe and effective and substantially equivalent in comparison with the predicate device.

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.