Digital Flat Panel X-ray Detector, HAD1717MC is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.

Device Description

This is a wired digital flat panel x-ray detector, a fast and efficient digital radiography system. The detector is used in combination with a TFT glass and scintillator (CSI) and supports automatic trigger signal detection technology that can be used without generator integration. The incident X-rays are converted into visible light that produces electron hole pairs in a photometer biased by scintillator material. The charge carier is stored in the photodiode capacity. By pulse processing the gates of the TFT lines in the matrix, charges in all the columns are transferred in parallel with the signal output. All signals on the column are amplified by a custom Read Out IC for further processing. The amplified signal is digitized using an A / D converter integrated into the ROIC. The digitized signal is transmitted to the PC. The device software is new software. When transferred to a PC, the software can acquire and store digitized images and view the images.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Digital Flat Panel X-ray Detector, HAD1717MC). It outlines the device description, technological characteristics, and non-clinical testing. However, it does not contain acceptance criteria for device performance nor a detailed study proving the device meets specific acceptance criteria in the format requested.

The "Performance data" section vaguely states that non-clinical testing data included MTF and DQE measurements "as tested by IEC 6220-1" and that "All test results were satisfying with the IEC6220-1 standards." This implies the standard itself sets the acceptance criteria, but these criteria are not explicitly listed, nor are the reported performance values. The "Clinical Data" section states that clinical images were obtained and confirmed "equivalent diagnostic capability to the predicate device and its results demonstrate similar equivalence or slightly better," but no specific metrics, acceptance criteria, or detailed study methodology are provided.

Therefore, I cannot fully complete the requested table and answer all questions based solely on the provided text. I will extract what information is present and indicate where information is missing.

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

Performance Metric	Acceptance Criteria (Implied by standard)	Reported Device Performance
High Contrast Limiting Resolution	N/A (Standard is IEC 6220-1)	3.5 LP/mm
DQE (at 0.1 lp)	N/A (Standard is IEC 6220-1)	TYP. 70%
MTF (at 0.1 lp)	N/A (Standard is IEC 6220-1)	TYP. 95%
Clinical Image Diagnostic Capability	Equivalence to predicate device	Equivalent or slightly better

Missing Information: The specific acceptance criteria within IEC 6220-1 are not explicitly stated in the document. The document only mentions that the results satisfied the standard.

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

Missing Information: The document states "clinical images were obtained," but does not specify the sample size for the test set of clinical images, the country of origin, or if the data was retrospective or prospective.

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)

Missing Information: This information is not provided in the document.

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

Missing Information: This information is not provided in the document.

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. The document does not describe an MRMC comparative effectiveness study where human readers used AI assistance. The study described focused on the diagnostic capability of the device's images compared to a predicate device.

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

Yes, partially. The "Performance data" section refers to non-clinical testing for metrics like MTF and DQE, which are standalone measurements of the device's image quality performance. These are algorithm-only or device-only measurements without human interpretation in the loop. The "Clinical Data" section, however, implies human interpretation for diagnostic capability comparison.

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

Missing Information: The document vaguely mentions "clinical images were obtained... to confirm that the subject x-ray detector provides images of equivalent diagnostic capability to the predicate device." However, it does not specify how the "ground truth" for diagnostic capability in these clinical images was established (e.g., confirmed diagnosis by a panel of experts, pathology reports, patient outcomes).

8. The sample size for the training set

Not Applicable (or Missing Information): This device is a digital flat panel x-ray detector, not an AI or machine learning algorithm in the context of image interpretation that would typically have a "training set" of images in the way an AI diagnostic tool would. It produces images. If "training set" refers to data used for optimizing the device's image processing parameters, that information is not provided.

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

Not Applicable (or Missing Information): As above, the concept of a "training set" and associated "ground truth" is not directly applicable to this device in the context of the provided document.

Summary

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January 31, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue.

H&abyz % Mrs. April Lee Consultant Withus Group, Inc. 106 Superior IRVINE CA 92620

Re: K200018

Trade/Device Name: HAD1717MC Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: December 27, 2019 Received: January 3, 2020

Dear Mrs. Lee:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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) K200018

Device Name HAD1717MC

Indications for Use (Describe)

Digital Flat Panel X-ray Detector, HAD1717MC is intended for use in general projection radiographic applications wherever conventional screen-film systems may be used. This device is not intended for mammographic applications.

Type of Use (Select one or both, as applicable)
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☒ Prescription Use (Per 21 CFR 201.66; Select One)	☐ Over-The-Counter Use (21 CFR 201.66; Select One)
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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 H&abyz. The logo consists of a colorful flower-like graphic on the left and the company name "H&abyz" in a dark gray sans-serif font on the right. The flower graphic has four petals in different colors: green, red, purple, and orange.

H&abyz

1F, 2-dong, 41-16, Cheoinseong-ro, Namsa-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do, Republic of Korea, 17118 Tel: +82-70-4658-9306

510(k) Summary - K200018

Submitter

H&abyz Nam Kyu Hur 1F, 2-dong, 41-16, Cheoinseong-ro, Namsa-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do, 17118 Republic of Korea Email: hnk@abyzr.com Phone: +82-70-4658-9306

Device Information

Trade Name: HAD1717MC
Classification Name: Stationary X-Ray System ●
Common Name: Digital Flat Panel X-ray Detector ●
Product Code: MQB ●
Panel: Radiology
Regulation Number: 892.1680 ●
Device Class: Class II ●
Date prepared: 01/22/2020

Primary Predicate Device

K number: K152094 ●
Trade Name: GR40CW .
Classification Name: Stationary X-Ray System
Common Name: Digital Flat Panel X-ray Detector ●
Product Code: MQB
Panel: Radiology
Regulation Number: 892.1680 ●

Device Description

The incident X-rays are converted into visible light that produces electron hole pairs in a photometer biased by scintillator material. The charge carier is stored in the photodiode capacity. By pulse processing the gates of the TFT lines in the matrix, charges in all the columns are transferred in parallel with the signal output. All signals on the column are amplified by a custom Read Out IC for further processing.

The amplified signal is digitized using an A / D converter integrated into the ROIC. The digitized signal is transmitted to the PC. The device software is new software. When transferred to a PC, the software can acquire and store digitized images and view the images.

Indications for use

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Image /page/4/Picture/0 description: The image shows the logo for H&abyz. The logo consists of a colorful flower-like graphic on the left and the text "H&abyz" on the right. The flower graphic has five petals in different colors: red, green, purple, and orange. The text is in a simple, sans-serif font and is colored in a dark gray.

1F, 2-dong, 41-16, Cheoinseong-ro, Namsa-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do, Republic of Korea, 17118 Tel: +82-70-4658-9306

Summary of Technological Characteristics

	Subject Device	Primary Predicate
Manufacturer	H&abyz	Samsung Electronics Co., Ltd.
510(k) Number	NA	K152094
Model	HAD1717MC	GR40CW
Indications for Use	Digital Flat Panel X-ray Detector,HAD1717MC is intended for use ingeneral projection radiographicapplications wherever conventionalscreen-film systems or CR systems maybe used. This device is not intended formammographic applications.	The GR40CW Digital X-ray ImagingSystem is intended for use in generalprojection radiographic applicationswherever conventional screen-filmsystems or CR systems may be used.This device is not intended formammographic applications.
Appearance	Image: Subject Device Appearance	Image: Primary Predicate Appearance
Detector
Panel Type	a-Silicon, TFT	a-Silicon, TFT
Scintillator	CsI	CsI
Detector Area	17 X 17 inches (427 x 427mm)	17 X 17 inches (425mm X 425mm)
Pixel Pitch (µm)	140	140
High Contrast LimitingResolution(LP/mm)	3.5	3.5
DQE	TYP. 70% at 0.1 lp	TYP. 70% at 0.1 lp
MTF	TYP. 95% at 0.1 lp	TYP. 95% at 0.1 lp
Imaging Workstation
CPU	Intel Core 2	Intel® Xeon® E5-1620
Memory (RAM)	4GB	8GB
Storage (HDD)	500GB	1TB
Monitor	1,920 x 1,080 pixels	21 inch (1,920 X1,080)
CIB(Control Interface Box)
Max. Signal InputVoltage	N/A	400V DC/AC

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Image /page/5/Picture/0 description: The image shows the logo for H&abyz. The logo consists of a colorful flower-like graphic on the left and the text "H&abyz" on the right. The flower graphic has four petals in red, green, purple, and orange. The text is in a dark gray color.

H&abyz

1F, 2-dong, 41-16, Cheoinseong-ro, Namsa-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do, Republic of Korea, 17118 Tel: +82-70-4658-9306

Similarities	The subject and predicate devices are same and similar in indications, design,technology, functions, and principle of operation.
Differences	DetectorArea	As the imaging area and number of pixels is calculated by effectivepixels, there may have some differences. However, this differencedoes not raise different questions of safety and effectiveness thanthe predicate.
	CPU	Subject medical device CPU has faster processing speed than thepredicate device's CPU, and the faster processing speed does notcontribute any adverse impacts to the device's safety andperformance.
	Memory(RAM)	Subject medical device memory size is smaller than the predicatedevice's memory size, and the memory size does not contributeany adverse impacts to the device's safety and performance.
	Storage(HDD)	Subject medical device Storage has smaller capacity than thepredicate device's Storage, and the small capacity does notcontribute any adverse impacts to the device's safety andperformance.
	Max. SignalInputVoltage	Subject medical device uses the TRIGGER line instead of the CIB.The CIB is managed by the x-ray system. The CIB only carries thesignal, and the HAD1717MC's Trigger cable also carries the signal.Therefore, this difference does not raise different questions ofsafety and effectiveness than the predicate.

Non-clinical Testing

Electrical Safety and Electromagnetic Compatibility

Electrical, mechanical, environmental safety and performance testing were conducted according to standard ES 60601-1(2006/A1:2013), and EMC testing was conducted according to IEC 60601-1-2(2015). All test results were satisfying with the standards.

2) Performance data

Non-clinical testing data was provided in conformance to the FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices", which includes MTF and DQE measurements as tested by IEC 6220-1. All test results were satisfying with the IEC6220-1 standards.

Clinical Data

In clinical data, clinical images were obtained in accordance with FDA guidance for the submission of 510(k)'s for Solid State X-ray Imaging Devices. The study confirmed that the subject x-ray detector provides images of equivalent diagnostic capability to the predicate device and its results demonstrate similar equivalence or slightly better.

Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification H&abyz concludes that Digital Flat Panel X-ray Detector is similar equivalent in comparison with the predicate device as described herein.

Regulation Number and Section

N/A