ADD (Digital Flat Panel X-Ray Detector) is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy targeting both adult and children. It is intended to replace film based radiographic diagnostic systems. Not to be used for mammography.

Device Description

The ADD are wired or wireless digital flat panel detectors that have been designed for faster, more streamlined approach to digital radiography systems. The ADD detector utilize a combination of propriety TFT glass and scintillators(CsI), and those and electronics are housed in one package. The detectors support an auto-trigger signal sensing technology that allows the detectors to be used without generator integration.

The flat panel sensors of the ADD are fabricated using thin film technology based on amorphous silicon technology. Electronically, the sensors are much like conventional photodiode arrays. Each pixel in the array consists of a light-sensing photodiode and a switching Thin Film Transistor (TFT) in the same electronic circuit. Amorphous silicon photodiodes are sensitive to visible light, with a response curve roughly comparable to human vision. The sensitivity of amorphous silicon photodiodes peaks in green wavelengths, well matched to scintillators such as CsI. The response has the excellent linearity of a charge-integrating-biased photodiode.

SDK-MCW is the software of Detector that performs image acquisition, image correction, and preprocessing.

AI/ML Overview

The provided text is a 510(k) summary for the ADD Digital Flat Panel X-Ray Detector. It establishes substantial equivalence to a predicate device (K203188) and does not contain detailed information about a study proving the device meets specific acceptance criteria in the manner expected for a clinical performance study with predefined metrics like sensitivity, specificity, or AUC, typically found in AI/CAD device approvals.

Instead, the submission focuses on non-clinical performance tests, software validation, and a comparison of technological characteristics to demonstrate substantial equivalence to the predicate device. The "clinical test summary" section explicitly states that clinical images were provided, but “these images were not necessary to establish substantial equivalence based on the differences from the predicate… but they provide further evidence… that the subject digital detector works as intended.” This implies that the primary basis for equivalence is non-clinical.

Therefore, many of the requested items related to clinical study design (sample size, expert qualifications, adjudication, MRMC studies, standalone performance with specific metrics like sensitivity/specificity) are not explicitly present or are not applicable in the context of this 510(k) summary. The acceptance criteria are primarily derived from compliance with standards and demonstrating similar performance to the predicate device.

Here's an attempt to answer your questions based on the provided text, acknowledging where information is not available:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are primarily based on demonstrating performance similar to or meeting the specified values of the predicate device and compliance with relevant industry standards for electrical safety, EMC, and imaging performance (DQE, MTF, resolution).

Acceptance Criteria (Derived from Predicate Comparison & Standards)	Reported Device Performance (ADD)	Evidence/Study
Technological Characteristics:
Scintillator: CsI	CsI	Comparison Table
Pixel Pitch: 140um	140um	Comparison Table
High Contrast Limiting Resolution: Max. 3.5 LP/mm	Max. 3.5 LP/mm	Comparison Table
Communication: Wired/Wireless	Wired/Wireless	Comparison Table
DQE: 50% (0.1lp/mm, min.)	50% (0.1lp/mm, min.)	Comparison Table & Performance Test
MTF: 97% (0.1lp/mm, min.)	97% (0.1lp/mm, min.)	Comparison Table
Anatomical Sites: General	General	Comparison Table
Exposure Mode: Normal Mode(Manual), AED Mode(Auto Detection)	Normal Mode(Manual), AED Mode(Auto Detection)	Comparison Table
Wireless: IEEE 802.11a/b/g/n	IEEE 802.11a/b/g/n	Comparison Table
Electrical Safety: IEC 60601-1 compliant	Complies with IEC 60601-1	Non-Clinical Test Summary
EMC: IEC 60601-1-2 compliant	Complies with IEC 60601-1-2	Non-Clinical Test Summary
Software Validation: Moderate Level of Concern, V&V completed	Software V&V completed	Non-Clinical Test Summary
Biocompatibility: ISO 10993-1 and series compliant	Complies with ISO 10993-1	Non-Clinical Test Summary
Imaging Performance Test: IEC 62220-1 compliant	Complies with IEC 62220-1	Non-Clinical Test Summary
Cybersecurity: FDA Guidance compliant	Complies with FDA Guidance	Non-Clinical Test Summary
Labeling: CFR Part 801, Pediatric Guidance compliant	Complies	Non-Clinical Test Summary

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions that "Clinical images were provided" but explicitly states they "were not necessary to establish substantial equivalence." This suggests that if there was a "test set" of clinical images, it was for supplementary evidence rather than a primary determinant of substantial equivalence, and its specifics (size, provenance, retrospective/prospective nature) are not detailed in this summary. The primary basis for comparison was non-clinical technical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable or not provided. Since the clinical images were "not necessary to establish substantial equivalence," specific details about ground truth establishment by experts for a dedicated clinical performance test set are not given.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable or not provided. (See point 3).

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 MRMC comparative effectiveness study is mentioned. The device is a digital X-ray detector, not an AI or CAD system designed to assist human readers. The clinical images provided were to demonstrate the detector "works as intended," not to show improvement in human reader performance.

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

The ADD is a digital flat panel X-ray detector, which captures images. It is not an algorithm for diagnosis, so the concept of "standalone performance" in the context of an AI algorithm is not directly applicable. Its performance is measured by imaging characteristics like DQE, MTF, and resolution.

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

For the non-clinical performance tests (DQE, MTF, resolution), the "ground truth" refers to established physical standards and measurement protocols, not clinical ground truth derived from expert consensus, pathology, or outcomes data. For any "clinical images" that might have been reviewed, the ground truth source is not specified because its review was stated as "not necessary."

8. The sample size for the training set

Not applicable. The ADD is a hardware device (detector) with associated software for image acquisition, correction, and preprocessing. While the software was developed and validated, this is not an AI/ML algorithm that requires a "training set" of diagnostic images in the conventional sense. The "training set" concept is typically relevant for machine learning models, which this device does not appear to be.

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

Not applicable. (See point 8).

Summary

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November 15, 2021

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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

H&abyz Co., Ltd. % Hyunook (David) Han Regulatory Affairs Manager 1F, 2-Dong, 41-16 Cheoinseong-ro Namsa-myeon, Cheoin-gu Yongin-si. Gyeonggi-do 17118 REPUBLIC OF KOREA

Re: K213497

Trade/Device Name: ADD Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: August 21, 2021 Received: November 1, 2021

Dear Hyunook (David) Han:

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) K213497

Device Name ADD

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

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510(k) Summary

[As Required by 21 CFR 807.92] K213497

1. Date Prepared [21 CFR 807.92(a)(a)]

October 28, 2021

2. Submitter's Information [21 CFR 807.92(a)(1)]

Name of Manufacturer: H&abyz Co., Ltd.
Address: 1F, 2-Dong, 41-16 Cheoinseong-Ro, Namsa-Myeon, Cheoin-Gu, Yongin-Si, Gyeonggi-Do, Republic of Korea [17118] ● Contact Name: Namkyu Hur / Quality Manager
Telephone No.: +82 070-4658-9300
Email Address: hho@abyzr.com
Registration No.: 3016674851

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade/Device/Model Name	ADD
Reference No.	HAD1417MCW, HAD1717MCW
Common Name	Digital Flat Panel X-ray Detector
Device Classification Name	Stationary X-ray System
Regulation Number	21 CFR 892.1680
Classification Product Code	MQB
Device Class	II
510(k) Review Panel	Radiology

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4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate device within this submission are shown as follow;

Predicate Device

●	510(k) Number:	K203188
●	Applicant:	H&abyz Co., Ltd.
●	Trade/Device Name:	ADD
●	Common Name:	Digital Diagnostic X-ray System
●	Classification Name:	System. X-ray, Stationary
●	Regulation Number:	21 CFR 892.1680
●	Classification ProductCode	MQB
●	Device Class:	II
●	510(k) Review Panel:	Radiology

These predicate devices have not been subject to a design-related recall

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5. Description of the Device [21 CFR 807.92(a)(4)]

SDK-MCW is the software of Detector that performs image acquisition, image correction, and preprocessing. According to the FDA quidance document entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," it has a moderate level of concern. Also, it does not base on previously-cleared software and was originally coded.

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6. Indications for use [21 CFR 807.92(a)(5)]

7. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)]

There are no significant differences in the technological characteristics of these devices compared to the predicate device which adversely affect safety or effectiveness. Provided below is a table summarizing and comparing the technological characteristics of the ADD and the predicate device:

	Predicate Device	Proposed Device	Note
K Number	K203188		-
Manufacturer	H&abyz Co., Ltd.	H&abyz Co., Ltd.	-
Trade Name	ADD	ADD	-
Common Name	Digital Flat Panel X-ray Detector	Digital Flat Panel X-ray Detector	Same
Product Code	MQB	MQB	Same
RegulationNumber	21 CFR 892.1680	21 CFR 892.1680	Same
510(k) ReviewPanel	Radiology	Radiology	Same
Indications forUse	ADD (Digital Flat Panel X-RayDetector) is indicated for digitalimaging solution designed forproviding general radiographicdiagnosis of human anatomytargeting both adult and children.It is intended to replace filmbased radiographic diagnostic.Not to be used for mammography.	ADD (Digital Flat Panel X-RayDetector) is indicated for digitalimaging solution designed forproviding general radiographicdiagnosis of human anatomytargeting both adult and children.It is intended to replace filmbased radiographic diagnostic.Not to be used for mammography	Same
Detector name	HAD1417MCW	HAD1417MCWHAD1717MCW	Difference
Scintillator	CsI	CsI	Same
Effective PixelArea	[HAD1417MCW]345.24 x 425.6 mm	[HAD1417MCW]345.24 x 425.6 mm[HAD1717MCW]425.04 x 425.6 mm	Difference
Total PixelNumber	[HAD1417MCW]2,560 x 3,072 pixels	[HAD1417MCW]2,560 x 3,072 pixels[HAD1717MCW]3072 x 3,072 pixels	Difference
Pixel Pitch	140um	140um	Same
High ContrastLimitingResolution(LP/mm)	Max. 3.5	Max. 3.5	Same

[Table 1. Comparison of Proposed Device to Predicate Devices]

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	Predicate Device	Proposed Device	Note
Communication	Wired/Wireless	Wired/Wireless	Same
DQE	50% (0.1lp/mm, min.)	50% (0.1lp/mm, min.)	Same
MTF	97% (0.1lp/mm, min.)	97% (0.1lp/mm, min.)	Same
AnatomicalSites	General	General	Same
Exposure Mode	Normal Mode(Manual),AED Mode(AutoDetection)	Normal Mode(Manual),AED Mode (AutoDetection)	Same
Wireless	IEEE 802.11a/b/g/n	IEEE 802.11a/b/g/n	Same

The proposed device is substantially equivalent to the previously cleared detector provided as part of the complete imaging system.

It is substantially equivalent to these devices in design, function, materials, operational principles, and intended use. The proposed device has been tested about electrical safety, EMC, and performance, and the software has been validated. Also, the clinical data has been provided to support the substantial equivalence to the predicate device.

The only difference is the size of the detectors, and it is a difference only in the area where the xray image can be taken. And a result of verification, it was confirmed that there is no difference in other performance. Therefore, the difference in the sizes of the detectors does not affect the safety and effectiveness. These differences do not raise different questions of safety and effectiveness than the predicate.

8. Non-Clinical Test summary

The ADD complies with voluntary standards for electrical safety, electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:

1. Electrical Safety, Electromagnetic Compatibility and Performance:
  The ADD complies with the electrical safety and electromagnetic compatibility requirements established by the standards.

StandardsNo.	StandardsOrganization	Standard Title	Version	PublicationYear
ES60601-1	AAMI ANSI	Medical Electrical Equipment - Part 1: GeneralRequirements for Basic Safety and EssentialPerformance (IEC 60601-1:2005, MOD)	ES60601-1:2005(R)2012 andA1:2012	2014
60601-1-2	IEC	Medical Electrical Equipment - Part 1-2: GeneralRequirements for Safety – Collateral Standard:Electromagnetic Compatibility - Requirementsand Tests	60601-1-2Edition 4.02014-02	2016
-	FDA	Radio Frequency Wireless Technology in MedicalDevices	August 14	2013

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2) Software Validation

The ADD contains MODERATE level of concern software. The software was designed and developed according to a software development process and was verified and validated. Software information is provided in accordance with FDA quidance:

The content of premarket submissions for software contained in medical devices, on May 11, 2005

3) Biocompatibility

ISO 10993-1 and series. Biological evaluation of medical devices .

4) Performance Test

Imaging performance test has been conducted according to:

IEC 62220-1, Medical Electrical Equipment – Characteristics of Digital X-ray Imaging Devices – Part 1-1: Determination of the Detective Quantum Efficiency – Detectors Used in Radiographic Imaging.
We select the predicate device in order to demonstrate adequate DQE performance of the ADD detector. According to the above comparison table, subject device shows similar or same DQE.

Cybersecurity

. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, on October2, 2014

Label

CFR Part 801
Pediatric Information for X-ray Imaging Device Premarket Notifications, on November 28, 2017

9. Clinical Test Summary

Clinical data has been provided according to FDA guidance document "Guidance for the Submission of 510(k)s for Solid Sate X-ray Imaging Devices". Clinical images were provided; these images were not necessary to establish substantial equivalence based on the differences from the predicate (note TFT technology with CsI scintillator that is identical to the predicate image plate) but they provide further evidence in addition to the laboratory performance data to show that the subject digital detector works as intended.

10. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]

There are no significant differences between the ADD and the predicate device, K203188 that would adversely affect the use of the product. It is substantially equivalent to these devices in indications for use and technology characteristics.

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11. Conclusion [21 CFR 807.92(b)(3)]

In according with the Federal Food & Drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, concludes that the subject device is substantially equivalent in safety and effectiveness to the predicate device as described herein.

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.