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

1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology. The wireless LAN (IEEE 802.11 n/ac) communication signals images captured to the system and improves the user operability through high speed processing. These radiographic image detectors are processing unit consist of a scintillator coupled to an a-Si TFT sensor. These devices need to be integrated with a static radiographic imaging system. It can be utilized to capture and digitalize X-ray images for radiographic diagnosis.

The revised 510k Summary specified that 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF includes the software (firmware) of MODERATE level of concern. It's the same Image Acquisition and Operating Software used for the predictive device is used but modified to include additional detector models in comparison with the predicate device.

The RAW files can be further processed as DICOM compatible image files by separate consol SW (K190866, XmaruView V1 / Rayence Co.,Ltd) for a radiographic diagnosis and analysis. The imaging software XMaru View V1 is not part of the subject device.

1417WCE is the basic model. 1417WCE-HR is identical with the basic model except for the pixel pitch size. 417WCE-HS is identical with the basic model except for the case color. 1417WCE-GF is identical with the basic model except for the case color and the pixel pitch size. The differences are not safety related.

AI/ML Overview

The provided text is a 510(k) summary for Rayence Co., Ltd.'s X-ray detectors (1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF). It describes the substantial equivalence of these new devices to a previously cleared predicate device (1417WCC, K171418), rather than proving the device meets a specific set of new clinical acceptance criteria through a clinical study.

The core of this submission is non-clinical performance testing to demonstrate that the new devices perform equivalently or better than the predicate, not a clinical study proving diagnostic accuracy or human performance improvement.

Therefore, many of the requested elements for a clinical study (like sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance with ground truth methods, and training set details) are not applicable or not explicitly stated in this type of submission.

However, I can extract information related to the acceptance criteria implicitly used for substantial equivalence and the non-clinical study details that support the performance claims.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance (Implicit for Substantial Equivalence)

The acceptance criteria for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to the predicate device (1417WCC). This means showing that the new devices are as safe and effective as the predicate. The "performance" in this context refers to technical imaging characteristics rather than diagnostic accuracy in a clinical setting.

Implicit Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (New Devices vs. Predicate)
Identical Indications for Use	Met: All new models have identical Indications for Use as the predicate: "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."
Similar Technological Characteristics:
- Detector Type	Met: All new models use Amorphous Silicon, TFT, same as predicate.
- Scintillator	Met: All new models use CsI:Tl, same as predicate.
- Imaging Area	Met: All new models have 14 x 17 inches, same as predicate.
- Pixel Matrix / Pixel Pitch	Similar: New models offer 100μm and 140μm pixel pitches (3534x4302 and 2500x3052 pixel matrices). Predicate had 127μm and 140μm (3328x2816 and 2500x3052). Differences "do not raise new concerns for safety and effectiveness."
- Resolution	Similar: New models show 5.00 lp/mm (100μm) and 3.57 lp/mm (140μm). Predicate had 3.93 lp/mm (127μm) and 3.57 lp/mm (140μm). Generally comparable or improved.
- DQE (@1lp/mm)	Similar/Better: New models: Typ. 62% (100μm), 63% (140μm). Predicate: Typ. 59% (127μm), 61% (140μm). The new models show slightly higher DQE.
- MTF (@1lp/mm)	Similar/Better: New models: Typ. 60% (100μm), 66% (140μm). Predicate: Typ. 55% (127μm), 53% (140μm). The new models show higher MTF.
- A/D Conversion	Similar: New models use 16 bits. Predicate used 14/16 bits.
- Dimensions & Weight	Similar: Comparable dimensions and weight.
Equivalent or Better Image Quality (Qualitative Review)	Met: "After comparing a broad review of plain radiographic images taken with 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF and 1417WCC images obtained equivalent quality for the same view obtained from a similar patient."
Sufficient Image Quality for Diagnostic Purposes	Met: "both 1417 WCE 140 um and 1417 WCE 100 um have demonstrated sufficient image quality which will provide aid for diagnostic purposes." (Specifically, 100um showed "sharper cortical lines," and 140um showed "sharper cortical lines and trabecular patterns with less image noise and overall better contrast.")
Conformance to Relevant Standards	Met: Non-clinical tests performed according to IEC 62220-1. Electrical, mechanical and environmental safety testing according to IEC 60601-1, EMC testing to IEC 60601-1-2.
Risk Mitigation	Met: FMEA method used for risk analysis. "overall assessment concluded that all risks and hazardous conditions identified arising from the design change were successfully mitigated and accepted."

Study Details (Non-Clinical Performance Testing for Substantial Equivalence)

The provided document describes non-clinical performance testing and a qualitative image review to support substantial equivalence, rather than a full-scale clinical trial with human subjects and diagnostic outcomes.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of number of images or patients for the qualitative review. The document mentions comparing "plain radiographic images" from the new devices and the predicate.
- Data Provenance: Not explicitly stated (e.g., country of origin). The comparison indicates the images were "taken with" the devices and from "a similar patient," implying they were internally generated or acquired for comparison. It was a retrospective comparison of existing image types (though not necessarily existing patient data in a large dataset).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable in the traditional sense of diagnostic ground truth. For the qualitative image review, the document states: "After comparing a broad review of plain radiographic images... images obtained equivalent quality..." This implies a subjective assessment, likely by internal experts, but the number and qualifications are not specified. This is a technical comparison for substantial equivalence, not a diagnostic accuracy study requiring independent expert ground truth for clinical endpoints.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None described. The qualitative image review mentions a "broad review," implying an assessment was made, but no formal adjudication process (like 2+1 reader agreement) is detailed.
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, an MRMC comparative effectiveness study was NOT done. This submission is for digital X-ray detectors themselves, not an AI-powered diagnostic assistance tool. Therefore, a study on human reader improvement with AI assistance is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in the sense of technical performance testing. The device's technical performance (MTF, DQE, NPS) was evaluated "algorithm only" (as in, device output without human interpretation in the loop) and compared to the predicate device, following international standards (IEC 62220-1). However, this is not a "standalone performance" study measuring diagnostic accuracy.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Primarily
  technical specifications and qualitative comparison; no traditional diagnostic ground truth. The "ground truth" for this submission are the measured physical properties of the detectors (e.g., MTF, DQE values determined by standardized phantoms) and the subjective assessment of image quality against the predicate. This is sufficient for demonstrating substantial equivalence for a medical imaging device (detector), not for an AI algorithm that provides a diagnostic output.
The sample size for the training set:
- Not Applicable. This submission is for a physical X-ray detector, not an AI or machine learning algorithm that requires a "training set."
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for this device type, no ground truth needed to be established for it.

Summary

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June 21, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Rayence Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 7505 Fannin St., Ste 610 HOUSTON TX 77054

Re: K231467

Trade/Device Name: 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: May 17, 2023 Received: May 22, 2023

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231467

Device Name 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF

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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510(k) Summary K231467

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

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@mtechgroupllc.com)
Address:	7505 Fannin St. Ste 610, Houston, TX 77054
Telephone:	+713-467-2607

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	: 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF
Common Name	: Digital Flat Panel X-ray Detector
Regulation Number	: 21 CFR 892.1680
Regulation Name	: Stationary X-ray System
Regulatory Class	: Class II
Product Code	: MQB
Predicate Device :
Trade/Device Name	: 1417WCC
Common Name	: Digital Flat Panel X-ray Detector
510(k) Number	: K171418
Regulation Number	: 21 CFR 892.1680
Regulation Name	: Stationary X-ray System
Regulatory Class	: Class II
Product Code	: MQB

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2. Device Description

Model	Color	Pixel pitch
1417WCE	White	140um
1417WCE-HR	White	100um
1417WCE-GF	Black	100um
1417WCE-HS	White & Green Mark	140um

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3. Indication for use

4. Summary of Design Control Risk management

1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF digital X-ray detectors are modification of 1417WCC (K171418).

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.

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

Detector described in this 510(k) has the same indications for use and similar technical characteristics as its predicate devices (K171418).

5.1 Scintillator layer

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

Scintillator Type	Proposed	Predicate
CsI (Cesium Iodide)	1417WCE, 1417WCE-HR,	1417WCC 127 um
	1417WCE-HS、1417WCE-GF	and1417WCC 140 um

5.2 Power source

		Proposed1417WCE, 1417WCE-HR,1417WCE-HS, 1417WCE-GF	Predicate1417WCC_127 μmand1417WCC_140 μm
Power	Type	Power supply	Power supply
	Model name	RP003A	RP003A
	Dimension	188 X 92 X 41.5	188 X 92 X 41.5
	Weight	0.5	0.5
	Rating	Input: 100-240VAC (50/60Hz)Output: 24VDC (Max 1.7A)	Input: 100-240VAC (50/60Hz)Output: 24VDC (Max 1.7A)

5.3 Recommended Generator specifications

Model	Manufacture	Specification
CMP 200	Communications & Power Industries		32kW	40kW	50kW
		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

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rayence

510(k)Submission –1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF

5.4 Comparison table

		Subject device				Predicate device
Model	1417WCE	1417WCE-HR	1417WCE-HS	1417WCE-GF	1417WCC	Similarity
Feature	Image: [image of 1417WCE]	Image: [image of 1417WCE-HR]	Image: [image of 1417WCE-HS]	Image: [image of 1417WCE-GF]	Image: [image of 1417WCC]
IntendedUse	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.	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.	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.	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.	Flat Panel 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.	Same
DetectorType	Amorphous Silicon, TFT	Amorphous Silicon, TFT	Amorphous Silicon, TFT	Amorphous Silicon, TFT	Amorphous Silicon, TFT	Same
Scintillator	CsI:Tl	CsI:Tl	CsI:Tl	CsI:Tl	CsI:Tl	Same
ImagingArea	14 x 17 inches	14 x 17 inches	14 x 17 inches	14 x 17 inches	14 x 17 inches	Same
Pixelmatrix	140 type: 2500 X 3052	100 type: 3534 X 4302	140 type: 2500 X 3052	100 type: 3534 X 4302	127type: 3328 X 2816140type: 2500 X 3052	Similar
Pixel pitch	140 μm	100μm	140 μm	100μm	127 μm, 140 μm	Similar
Resolution	140 type: 3.57 lp/mm	100 type: 5.00 lp/mm	140 type: 3.57 lp/mm	100 type: 5.00 lp/mm	127 type: 3.93140 type: 3.57	Similar
DQE(@1lp/mm)	100μm : Typ. 62 %140μm : Typ. 63%	100μm : Typ. 62 %140μm : Typ. 63%	100μm : Typ. 62 %140μm : Typ. 63%	100μm : Typ. 62 %140μm : Typ. 63%	127μm : Typ. 59%140μm : Typ. 61%	Similar
MTF(@1lp/mm)	100 : Typ 60%140 : Typ 66%	100 : Typ 60%140 : Typ 66%	100 : Typ 60%140 : Typ 66%	100 : Typ 60%140 : Typ 66%	127μm : Typ. 55%140μm : Typ. 53%	Similar
A/DConv	16 bits	16 bits	16 bits	16 bits	14 / 16 bits	Similar
Dimensions	384 X 460 X 15mm	384 X 460 X 15mm	384 X 460 X 15mm	384 X 460 X 15mm	460 X 384 X 15mm	Similar
Weight	≤ 2.7 kg	≤ 2.7 kg	≤ 2.7 kg	≤ 2.7 kg	3 (incl. battery)	Similar

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6. Summary of Performance Testing

1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF X-ray detectors have same indications for use, scintillator material (Csl:T1), general specifications and same risk analysis characteristics compared to the predicate device, 1417WCC (K171418). The pixel matrix and pixel pitch sizes are different due to different imaging areas but the differences do not raise new concerns for the safety and effectiveness of the subject device.

The non-clinical test report for the subject device were prepared and submitted to FDA to demonstrate the substantial equivalency of the subject device performance compared to the predicate device.

After comparing a broad review of plain radiographic images taken with 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF and 1417WCC images obtained equivalent quality for the same view obtained from a similar patient .

bony structure details of hands, fingers and feet had better clarity in the 1417WCE 100um as they showed sharper cortical lines which would be better in evaluating long bone fractures. 1417WCC 140um images showed sharper cortical lines and trabecular patterns with less image noise and overall better contrast.

In conclusion, both 1417 WCE 140 um and 1417 WCE 100 um have demonstrated sufficient image quality which will provide aid for diagnostic purposes.

The non-clinical test report contains the MTF, DQE and NPS performance test comparison between the subject device, and the predicate device, by using the identical test equipment and same analysis method described by IEC 62220-1.

Based on the non-clinical consideration evaluation, the sponsor can claim the substantial equivalency between the subject device and the predicate device in terms of diagnostic image quality.

The manufacturing facility is in conformance with the design control procedure requirements specified in 21 CFR 820.30 and the relevant 21CFR820 standards as the records are available for review.

7. Summary for any testing and reference guidance:

A Electrical, mechanical, environmental safety and performance testing according to

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standard IEC 60601-1: 2005, COR1:2006, COR2:2007, AMD1:2012 (Medical electrical equipment Part 1:General requirements for basic safety and essential performance)

A EMC testing were conducted in accordance with standard IEC 60601-1-2: 2014
A IEC 6220-1:2015 Ed 1.0 Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiency Detectors used in radiographic imaging
A Non-clinical consideration according to FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices"
A "Guidance for the Contents of Premarket Submission for Software Contained in Medical Device".
A Pediatric Information for X-ray Imaging Device Premarket Notifications
A Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

8. Conclusions:

In accordance with the performance outcomes, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF X-ray detectors demonstrated equivalent or better performance compared to 1417WCC. Therefore, Rayence claims the substantial equivalency between the subject device and the predicate device in terms of diagnostic image quality about safety and effectiveness.

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.