The RFA-1717DI 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 system in all general-purpose diagnostic procedures. It is not to be used for mammography.

Device Description

The RFA-1717DI detector is a digital X-ray flat panel detector which has 43cm x 43cm imaging area and communicates with a wired communication feature. Giga-bit Ethernet communication method through connection of tether cable. The RFA-1717 detector is available in two types of scintillator: Csl: Tl type for RFA-1717DIC model and Gadox:Tb type for RFA-1717DIG model. The device accepts x-ray photons and the scintillator and emits visible spectrum photons that illuminate an array of photo (IGZO)-detector that creates electrical signals. After the electrical signals are generated, it is converted to digital values, and the images will be displayed on the monitor. This device should be integrated with an operating PC and an X-Ray generator. It can digitalize x-ray images and transfer them for radiography diagnostics. Advanced digital image processing allows considerably efficient diagnosis and imaging data management on network.

AI/ML Overview

This document describes a 510(k) submission for the RFA-1717DI digital flat panel X-ray detector, seeking substantial equivalence to existing predicate devices. As such, the acceptance criteria and study described are for a non-clinical performance evaluation comparing the new device to established predicates, rather than a clinical study evaluating the impact of an AI algorithm on human reader performance.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating comparability to the predicate devices. The "performance" here refers to the technical specifications and measurements of the device itself, rather than diagnostic accuracy.

Characteristic	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (RFA-1717DI)	Remark
Intended Use	Same as predicate	For digital imaging solution designed for general radiographic system for human anatomy. Intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. Not to be used for mammography.	Same. This is a critical point for demonstrating substantial equivalence.
Detector Type	Amorphous Silicon, TFT	IGZO, TFT	Similar. The change in material (IGZO vs Amorphous Silicon) for the Thin Film Transistor array is noted, but deemed "similar" in the context of overall performance equivalence.
Scintillator	LTX240AA01: CsI; LLX240AB01: GdOS	RFA-1717DIC: Cesium Iodide: TI; RFA-1717DIG: Gadox : Tb	Same. While the specific chemical variations are slightly different (e.g., CsI vs CsI:Tl), the fundamental scintillator types used are the same as those present in the predicate devices.
Imaging Area	17 x 17 inches	17 x 17 inches	Same.
Pixel matrix	3072 x 3072 (9.4 million)	3072 x 3072 (9.4 million)	Same.
Pixel pitch	143μm	140μm	Similar. A slight difference, but within acceptable limits for a "similar" claim.
Resolution	3.5 lp/mm	3.4 lp/mm	Similar. A minor difference, still considered similar.
MTF (0.5 lp/mm)	GdOS: 76%; CsI: 81%	GdOS: 79%; CsI: 83%	Similar. The RFA-1717DI actually demonstrates slightly higher MTF (Modulation Transfer Function) values, which is generally a positive indicator of image quality. This supports the claim of equivalence.
DQE (1 lp/mm)	GdOS: 32%; CsI: 50%	GdOS: 34%; CsI: 60%	Similar. The RFA-1717DI demonstrates higher DQE (Detective Quantum Efficiency) values, which indicates better dose efficiency and image quality. This also supports the claim of equivalence.
A/D Conversion	14 bit	16 bit	Similar. The RFA-1717DI has a higher bit depth, allowing for more grayscale levels, which is an improvement but still within the scope of "similar" for its intended use.
Grayscale	16384 (14bit)	65350 (16bit)	Same. This reflects the higher A/D conversion, demonstrating improved grayscale capability while remaining within the expected performance of such devices. The document says "Same" despite the numerical difference, indicating it fulfills the "same" functional purpose.
Data output	RAW, convertible to DICOM 3.0	RAW, convertible to DICOM 3.0	Same.
Dimensions	500 x 496.6 x 45 mm	460 x 460 x 15 mm	Similar. Differences in physical dimensions are noted but do not impact the core functional equivalence for intended use.
Application	General Radiology system, various stands	General Radiology system, various stands	Same.
Electrical Safety	Conformance to IEC 60601-1	Conformance to IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012)	Demonstrated compliance with updated standards.
EMC Compliance	Conformance to IEC 60601-1-2	Conformance to IEC 60601-1-2: 2014, CISPR 11: 2015 Group 1, Class A, IEC61000-3-2: 2014, IEC 61000-3-3: 2013, EN 55011: 2009 +A1: 2010, EN 60601-1-2:2015. EN 61000-3-2:2014. EN 61000-3-3:2013.	Demonstrated compliance with updated standards.
Software Validation	Yes, predicate was validated	Software validation and verification testing performed.	Demonstrated compliance.
Risk Management	ISO 14971 compliance	ISO 14971: Risk management file A	Demonstrated compliance.

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 "test sets" in the traditional sense of a clinical trial with patient cases. The evaluation is primarily based on bench testing and technical performance measurements of the device itself (e.g., MTF, DQE, NPS).
Data Provenance: The testing was conducted by ASTEL Inc. (the manufacturer) and a 3rd party testing lab A (for electrical safety and EMC). The country of origin for the data (and manufacturing) is explicitly stated as Korea (26-79, Gajeongbuk-ro, Yuseong-gu, Daejeon, 34113, Korea). This was a prospective evaluation of the new device's performance against established standards, not a retrospective analysis of patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. For this type of device (a digital X-ray detector, not an AI diagnostic algorithm), "ground truth" is established via physical measurements and adherence to engineering standards, not clinical expert consensus on image interpretation.
Qualifications of Experts: The experts would be qualified engineers and physicists specializing in medical imaging device testing and regulatory compliance. The document mentions "3rd party testing lab A," implying accredited professionals conducted the safety and performance tests.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no human interpretation or diagnostic "ground truth" adjudicated for this type of device submission. The device's performance is objectively measured against physical and engineering standards.

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

Was it done? No. This type of study (MRMC) is typically performed for AI-powered diagnostic aids, where the impact of the AI on human reader performance is being evaluated. This submission is for a basic imaging acquisition device, not an AI diagnostic tool.
Effect Size: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was it done? Yes, in essence. The "non-clinical tests" and "performance testing/data" section describe the standalone performance of the RFA-1717DI detector. This includes measurements of MTF, DQE, and NPS, which are intrinsic performance metrics of the device itself, independent of human interpretation or any AI algorithm. The device's ability to produce images comparable to the predicate devices is the core of this "standalone" assessment.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for this device is based on objective physical and engineering standards and measurements. This includes:
- International Standards: IEC 62220-1 (for DQE, MTF, NPS performance), IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility).
- Predicate Device Specifications: The performance values of the legally marketed predicate devices (LLX240AB01 and LTX240AA01) serve as the benchmark for "substantial equivalence."
- Risk Management Standards: ISO 14971.

8. Sample Size for the Training Set

Sample Size: Not applicable. This is a 510(k) for a hardware device (X-ray detector). It does not involve AI algorithms that require a "training set" of data.

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

How Established: Not applicable, as there is no training set for this type of device.

Summary

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August 25, 2021

Image /page/0/Picture/1 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

ASTEL Inc. % Mr. Dave Kim President Mtech Group 7505 Fannin St. Ste 610 HOUSTON TX 77054

Re: K212051

Trade/Device Name: RFA-1717DI (RFA-1717DIG, RFA-1717DIC) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: June 25, 2021 Received: June 30, 2021

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,

, for

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K212051

Device Name RFA-1717DI (RFA-1717DIG, RFA-1717DIC)

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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Image /page/3/Picture/0 description: The image shows the logo for "ASTEL". The logo features a gray square on the left side, with a stylized white "A" that extends into the blue text "ASTEL". Below the text, there is a smaller line of text that reads "ASICs & Systems for telecommunications".

1. Traditional 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR Part 807.92.

Date 510K summary prepared : August 23, 2021

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

Submitter's Name :	ASTEL Inc.
Submitter's Address:	26-79, Gajeongbuk-ro, Yuseong-gu, Daejeon, 34113, Korea
Submitter's Telephone:	Tel:+82-42-360-2100
Contact person:	Mr. Yonghwan, Jeon / Director of DR Business Unit
Official Correspondent:	Dave Kim, MBA
Address:	Mtech Group7505 Fannin St. Ste 610, Houston, TX 77054
Telephone:	713-467-2607
Email:	davekim@mtech-inc.net

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:	RFA-1717DI
Model Name:	RFA-1717DIG, RFA-1717DIC
Regulation Name:	Digital Flat Panel X-ray Detector
Regulation Number:	21 CFR 892.1680
Regulatory Class:	II
Product Code:	MQB
Predicate Device
Device Name:	LLX240AB01(K102587) / LTX240AA01 (K090742)
Regulation Name:	Digital Flat Panel X-ray Detector
Regulation Number:	21 CFR 892.1680
Regulatory Class:	II
Product Code:	MQB

2. Device Description

K212051

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Image /page/4/Picture/0 description: The image shows the logo for NASTEL. The logo features a gray square with a white "N" inside, followed by the word "ASTEL" in blue. Below the logo, the text "ASICs & Systems for telecommunications" is written in a smaller font.

3. Indications for Use

The RFA-1717DI detector is indical imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all generalpurpose diagnostic procedures. It is not to be used for mammography.

4. Summary of Design Control Risk management

The RFA-1717DI detector has been developed to meet the critical functional requirements and international safety standards. The risks and the hazardous impact of the device design were analyzed with FMEA method. The specific risk control and protective measures to mitigate the risks from the device design and production phase 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 and production were successfully mitigated and accepted.

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

The RFA-1717DI detector described in this 510(k) have similar indications for use and technical characteristics as the predicate devices, LLX240AB01 (K102587) and LTX240AA01 (K090742) digital flat panel X-ray detector manufactured by Samsung Mobile Display Co., Ltd.

6. Substantial Equivalence

The RFA-1717DI detector and components conform to the FDA recognized standards. Based on the recognized standard conformity evidences related to electro-, mechanical-, software-, clinical-, and risk management, it is confirmed that The RFA-1717DI detector is substantially equivalent to the predicate devices.

Characteristic	ASTEL Inc.RFA-1717DI	Samsung Mobile DisplayLTX240AA01 / LLX240AB01	Remark
510(k)number	K212501	K090742 / K102587
Intended Use	The RFA-1717DI detector is indicatedfor digital imaging solution designedfor general radiographic system forhuman anatomy. It is intended toreplace film or screen basedradiographic system in all general-purpose diagnostic procedures. It isnot to be used for mammography.	LTX240AA01 Digital Flat Panel X-ray detector is indicated fordigital imaging solution designedfor general radiographic systemfor human anatomy. It isintended to replace film or screenbased radiographic systems in allgeneral purpose diagnosticprocedures. Not to be used formammography.LLX240AB01 Digital Flat Panel X-Ray Detector is indicated fordigital imaging solution designedfor providing generalradiographic diagnosis of humananatomy targeting both adult and	Same

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Image /page/5/Picture/0 description: The image is a logo for ASTEL. The logo has a gray square with a white "A" in it. To the right of the square is the word "ASTEL" in blue. Below the logo is the text "ASICs & Systems for telecommunications".

Detector Type	IGZO, TFT	Amorphous Silicon, TFT	Similar
Scintillator	RFA-1717DIC: Cesium Iodide: TIRFA-1717DIG: Gadox : Tb	LTX240AA01: CsILLX240AB01:GdOS	Same
Imaging Area	17 x 17 inches	17 x 17 inches	Same
Pixel matrix	3072 x 3072 (9.4 million)	3072 x 3072 (9.4 million)	Same
Pixel pitch	140μm	143μm	Similar
Resolution	3.4 lp/mm	3.5 lp/mm	Similar
MTF	79% at 0.5lp/mm (GdOS)83% at 0.5lp/mm (Csl)	76% at 0.5lp/mm (GdOS)81% at 0.5lp/mm (Csl)	Similar
DQE	34% at 1lp/mm (GdOS)60% at 1lp/mm (Csl)	32% at 1lp/mm (GdOS)50% at 1lp/mm (Csl)	Similar
A/Dconversion	16 bit	14 bit	Similar
Grayscale	65350 (16bit)	16384 (14bit)	Same
Data output	RAW*The RAW files are convertible intoDICOM 3.0 by console S/W	RAW*The RAW files are convertibleinto DICOM 3.0 by console S/W	Same
Dimensions	460 x 460 x 15 mm	500 x 496.6 x 45 mm	Similar
Application	General Radiology systemAvailable with upright stand, table,universal stand	General Radiology systemAvailable with upright stand,table, universal stand	Same
picture	Image: detector	Image: detector	Similar

When compared to LLX240AB01 (K102587) and LTX240AA01 (K090742), the RFA-1717DI presented in this submission has the same characteristics in:

Intended Use
Technological characteristics
Operating principle
Design features
Performance
Communication Method

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Image /page/6/Picture/0 description: The image is a logo for ASTEL. The logo features a gray square with a white "A" inside of it. To the right of the square is the word "ASTEL" in blue. Below the logo is the text "ASICs & Systems for telecommunications".

There is no significant difference between the RFA-1717DI and the predicate devices that would adversely affect the use of the product. Both devices are substantially equivalent in terms of design, function, materials, operational principles and intended use.

7. Performance Testing/Data

Results for verification and validation testing of the subject device was found acceptable to support the claims of substantial equivalence. Electrical safety and EMC compliance were tested according to the IEC Standards. ASTEL Inc. certifies conformance to Voluntary Standards covering electrical, mechanical safety and EMC compliance. In conclusion, the identified risk of electrical hazards was mitigated and is substantially equivalent to the predicate devices in terms of safety and effectiveness.

8. Description of non-clinical tests.

- Non-clinical study

The non-clinical performance testing of the subject device confirms that the performance values in comparison of DQE, MTF NPS are basically equivalent to the predicate devices, LLX240AB01 (K102587) and LTX240AA01 (K090742).

The non-clinical test report the subject device was prepared and submitted to FDA to demonstrate the substantial equivalency of the subject devices compared to each respective predicate devices. The nonclinical test report contains the MTF and DQE performance results of RFA-1717Dl in accordance with IEC 62220-1 standard. The comparative result of the MTF test for RFA-1717DI detector demonstrated that the MTF of RFA-1717DI performed similarly compare to the predicate devices. The DQE represents the ability to visualize object details of a certain size and contrast. RFA-1717DI demonstrated higher DQE performance than LLX240AB01 and LTX240AA01 at all spatial frequencies of both detectors.

-Electrical safety and EMC

RFA-1717DI has been tested for electrical safety standard IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 *2007) + AM1 (2012) and electromagnetic compatibility IEC 60601-1-2: 2014. CISPR 11: 2015 Group 1, Class A, IEC61000-3-2: 2014, IEC 61000-3-3: 2013, EN 55011: 2009 +A1: 2010, EN 60601-1-2:2015. EN 61000-3-2:2014. EN 61000-3-3:2013.

The software validation and verification testing was also performed. The results of nonclinical testing indicate that the RFA-1717DI detector is as safe and effective as the predicate devices.

Compliance evidences were submitted for the following standards:

IEC 60601-1: 2005, MOD Test Report issued by 3rd party testing lab A
IEC 60601-1-2: 2014, Test Report issued by 3rd party testing lab A
ISO 14971: Risk management file A
Non-clinical consideration according to FDA Guidance "Guidance for the Submissions of 510(k)'s A for Solid State X-ray Imaging Devices"
"Guidance for the Contents of Premarket Submission for Software Contained in Medical Device".

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Image /page/7/Picture/0 description: The image shows the logo for ASTEL. The logo consists of a gray square with a white triangle inside, followed by the word "ASTEL" in blue. Below the word "ASTEL" is the text "ASICs & Systems for telecommunications".

9. Description of clinical tests.

No clinical testing is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification. Bench testing is sufficient to assess the device safety and effectiveness, including demonstrating equivalent image quality.

Sample clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device but they provide further evidence in addition to the laboratory performance data to show that the subject device operates as indicated.

10. Conclusion as to Substantial Equivalence

The RFA-1717DI detector is substantially equivalent to the predicate devices LLX240AB01 (K102587) and LTX240AA01 (KJ090742). Both the subject and predicate devices are same or very similar in the intended use, the design principle, the performance and the applicable standards. Some characteristics, for example, appearance, pixel pitch and weight are different, However, the compliance reports, performance testing and clinical image review result in this submission STED demonstrate that these differences do not raise any new questions of safety and effectiveness. Therefore, ASTEL Inc. concludes the RFA-1717DI digital flat panel detector is substantially equivalent with the predicate devices LLX240AB01 (K102587) and LTX240AA01 (K090742) of Samsung Mobile Display Co., Ltd.

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.