The Flat Panel Digital X-ray Detector 17HQ901G-B 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

This model is an x-ray imaging device, a system that can acquire and process X-ray images as digital images. It utilizes amorphous silicon and a high-performance scintillator to ensure sharp high-definition image quality with the resolution of 3.6 lp/mm and the pixel pitches of 140 um. This device is a flat panel based X-ray image acquisition device. This device must be used in conjunction with an operating PC and an X-ray generator. This device can be used for digitizing and transferring X-ray images for radiological diagnosis. The data transmission between the Detector and PC can be enabled with a wired (cable) or wireless connection.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device (17HQ901G-B) and its substantial equivalence to a predicate device (14HQ901G-B). However, it does not contain information about acceptance criteria or a specific study proving the device meets those criteria, especially in the context of an AI/ML algorithm's performance.

The document primarily focuses on demonstrating the new device's equivalence to a previously cleared device for the purpose of FDA 510(k) clearance. This involves comparing technical specifications and showing compliance with various electrical safety, electromagnetic compatibility, software validation, biocompatibility, and cybersecurity standards.

Here's a breakdown of the requested information based on the provided text, highlighting what is missing:

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

The document does not specify quantitative acceptance criteria or a performance study to demonstrate the device meets such criteria for an AI/ML algorithm. It mentions performance tests for imaging devices in general, like IEC 62220-1 for Detective Quantum Efficiency (DQE):

Performance Metric (from IEC 62220-1)	Predicate Device (14HQ901G-B)	Proposed Device (17HQ901G-B)	Acceptance Criteria
DQE @ 0.1 lp/mm	Typ. 78%	Typ. 78%	Not specified
MTE @ 0.5 lp/mm	Typ. 84%	Typ. 84%	Not specified
High Contrast Limiting Resolution (LP/mm)	3.6 lp/mm	3.6 lp/mm	Not specified

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

This information is not provided in the document. The document states: "Clinical data has been provided according to FDA guidance document 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices'. The data was not necessary to establish substantial equivalence based on the modifications to the device but provided further evidence in addition to the laboratory performance data to show that the device works as intended." This implies that while clinical data was submitted, its details, including sample size, provenance, and study design, are not explicitly included in this 510(k) summary.

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)

This information is not provided. The document makes no mention of expert involvement in establishing ground truth for any test set.

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

This information is not provided.

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

This information is not provided. The device described is a flat panel digital X-ray detector, which is a hardware component for imaging, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be applicable to this specific device.

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

This information is not provided. As noted above, this device is a hardware component, not an algorithm.

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

This information is not provided.

8. The sample size for the training set

This information is not provided. The device is a hardware detector, and the document does not discuss any AI/ML models that would require a training set.

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

This information is not provided. (Consistent with point 8.)

In summary: The provided FDA 510(k) summary focuses on demonstrating the substantial equivalence of a new Flat Panel Digital X-ray Detector (17HQ901G-B) to an existing predicate device (14HQ901G-B) based on technical specifications and compliance with standards. It does not describe the evaluation of an AI/ML algorithm or its associated acceptance criteria, performance studies, sample sizes, expert ground truth, or adjudication methods typically found in submissions for AI/ML-powered medical devices. The "clinical data" mentioned served to further support the intended function and safety of the hardware device rather than the performance of an AI algorithm.

Summary

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May 5, 2022

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LG Electronics Inc. % Bokyeong Kim Senior Consultant GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul, Mapo-gu 03909 REPUBLIC OF KOREA

Re: K220559

Trade/Device Name: 17HQ901G-B Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: February 24, 2022 Received: February 28, 2022

Dear Bokyeong 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

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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 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 (OS) 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,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT 8B: 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) K220559

Device Name 17HQ901G-B

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]

K220559

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

February 24, 2022

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

• Name of Sponsor:- Address:	LG Electronics Inc.77, Sanho-daero, Gumi-si, Gyeongsangbuk-do, 39381,Republic of Korea
• Name of Manufacturer:- Address:	LG Electronics Inc.77, Sanho-daero, Gumi-si, Gyeongsangbuk-do, 39381,Republic of Korea
• Contact Name:- Telephone No.:- Email Address:	Jinhwan Jun / Chief Research Engineer+82-31-8066-5641jinhwan.jun@lge.com

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

Trade/Device/Model Name	17HQ901G-B
Common Name	Flat Panel Digital 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 devices within this submission are shown as follow;

Predicate Device

●	510(k) Number:	K214044
●	Applicant:	LG Electronics Inc.
●	Trade/Device Name:	14HQ901G-B
●	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

The 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)]

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

7. Intended Use [21 CFR 807.92(a)(5)]

The Flat Panel Digital X-ray Detector 17HQ901G-B is a prescription device, and it is not intended to be used for mammography.

The detector is indicated for digital imaging solution designed for general radiographic system for human anatomy
The detector is indicated to replace film or screen based radiographic systems in all general purpose diagnostic procedures.

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8. 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 devices which adversely affect safety or effectiveness. Provided below is a table summarizing and comparing the technological characteristics of the 17HQ901G-B and the predicate devices:

	Proposed Device	Predicate Device	Note
K Number	K220559	K214044	-
Manufacturer	LG Electronics Inc.	LG Electronics Inc.	Same
Trade Name	17HQ901G-B	14HQ901G-B	Same
Common Name	Flat Panel Digital X-ray Detector	Flat Panel Digital 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	The Flat Panel Digital X-ray Detector17HQ901G-B is indicated for digitalimaging solution designed for generalradiographic system for humananatomy. It is intended to replacefilm or screen based radiographicsystems in all general purposediagnostic procedures. Not to beused for mammography.	The Flat Panel Digital X-ray Detector14HQ901G-B is indicated for digitalimaging solution designed for generalradiographic system for humananatomy. It is intended to replacefilm or screen based radiographicsystems in all general purposediagnostic procedures. Not to beused for mammography.	Same
Intended use	The Flat Panel Digital X-ray Detector17HQ901G-B is a prescription device,and it is not intended to be used formammography.- The detector is indicated fordigital imaging solutiondesigned for generalradiographic system forhuman anatomy- The detector is indicated toreplace film or screen basedradiographic systems in allgeneral purpose diagnosticprocedures.	The Flat Panel Digital X-ray Detector14HQ901G-B is a prescription device,and it is not intended to be used formammography.- The detector is indicated fordigital imaging solutiondesigned for generalradiographic system forhuman anatomy- The detector is indicated toreplace film or screen basedradiographic systems in allgeneral purpose diagnosticprocedures.	Same
Detector
Scintillator	CsI	CsI	Same
Imaging Area	17 x 17 inches	14 x 17 inches	Different
Pixel Matrix	3,072 x 3,072 pixels	2,560 x 3,072 pixels	Different
Pixel Pitch	140 um	140 um	Same
High ContrastLimitingResolution(LP/mm)	3.6 lp/mm	3.6 lp/mm	Same
Communication	Wired/Wireless	Wired/Wireless	Same
DQE	Typ.78% @0.1lp/mm	Typ.78% @0.1lp/mm	Same
MTE	Typ.84% @0.5lp/mm	Typ.84% @0.5lp/mm	Same

	[Table 1. Comparison of Proposed Device to Predicate Device]
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510(k) Summary

17HQ901G-B

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	Proposed Device	Predicate Device	Note
Resolution	3.6lp	3.6lp	Same
Anatomical Sites	General	General	Same
Exposure Mode	Manual, Auto (AED)	Manual, Auto (AED)	Same
Semi Dynamicmode	O	O	Same
Wireless	Standard:802.11 a/b/g/n/ac complianceFrequency: 2.4 GHz/5GHzBandwidth: 20MHz/40MHz/80MHzMIMO: 2x2	Standard:802.11 a/b/g/n/ac complianceFrequency: 2.4 GHz/5GHzBandwidth: 20MHz/40MHz/80MHzMIMO: 2x2	Same
Rating	24V 2.1A	24V 2.1A	Same
Gap Analysis	There is some difference in the 'Imaging Area' and 'Pixel matrix. Imaging area andpixel matrix are not related to the device's 'safety and 'performance.' So Proposeddevice (17HQ901G-B) and Predicate Device (14HQ901G-B) are substantially same.

** Semi Dynamic mode is a function that can transmit five images per second to the PC.

There are no significant differences between the 17HQ901G-B and the predicate device that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use. The proposed device, 17HQ901G-B has been tested about electrical safety, EMC and performance, and the software has been validated. In addition, the clinical data has been provided to support the substantial equivalence to the predicate devices.

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9. Non-Clinical Test summary

The 17HQ901G-B comply with voluntary standards for electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:

Electrical Safety, Electromagnetic Compatibility and Performance:

The 17HQ901G-B comply with the electrical safety and electromagnetic compatibility requirements established by the standards.

StandardsNo.	StandardsOrganization	Standard Title	Version	PublicationYear
ES60601-1	AAMI	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

2) Software Validation

The 17HQ901G-B contains MODERATE level of concern software as firmware. 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.

5) Cybersecurity

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, on October 18, 2018
Postmarket Management of Cybersecurity in Medical Devices, on December 28, 2016

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6) Label

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

10. Clinical Test Summary

Clinical data has been provided according to FDA guidance document "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices". The data was not necessary to establish substantial equivalence based on the modifications to the device but provided further evidence in addition to the laboratory performance data to show that the device works as intended.

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

There are no significant differences between 17HQ901G-B and the predicate device, K214044 that would adversely affect the use of the product. It is substantially equivalent to these devices in indications for use and technology characteristics.

12. 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 LG Electronics, concludes that the 17HQ901G-B 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.