Flat Panel Digital X-ray Detector 14HQ901G-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 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 LG Electronics Inc. Flat Panel Digital X-ray Detector 14HQ901G-B and its substantial equivalence to a predicate device (17HK701G-W). The document primarily focuses on non-clinical tests and technological characteristics comparison rather than detailed clinical study data with specific acceptance criteria relating to diagnostic performance metrics (like sensitivity, specificity, accuracy).

However, the document states: "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'. 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, it wasn't the primary basis for the substantial equivalence determination. The primary basis appears to be the laboratory performance data and technological characteristics comparison.

Since detailed acceptance criteria and a description of a clinical study focusing on diagnostic performance metrics (e.g., sensitivity, specificity) with specific values for the proposed device are not provided in the extracted text, I can only extract general statements about clinical data being submitted. The text doesn't provide the quantifiable acceptance criteria for diagnostic performance or the results of such a study.

Therefore, for aspects related to diagnostic performance, I cannot fill in the table with specific values or answer questions about sample size, expert qualifications, or adjudication methods for a diagnostic performance study.

Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria for diagnostic performance (e.g., minimum sensitivity or specificity) nor does it provide a table of reported diagnostic performance metrics alongside such criteria. The "performance test" mentioned in Non-Clinical Test Summary refers to IEC 62220-1, which is about the Detective Quantum Efficiency (DQE), a physical imaging characteristic, not a diagnostic performance metric.

Feature / Metric	Acceptance Criteria (Not Explicitly Stated for Diagnostic Performance)	Reported Device Performance (as per non-clinical tests)
Diagnostic Performance	Not explicitly stated for clinical diagnostic performance.	Not explicitly stated for clinical diagnostic performance in the provided text.
Technological Characteristics (Comparison to Predicate)
High Contrast Limiting Resolution (LP/mm)	≥ 3.6 lp/mm (Implied equivalence to predicate)	3.6 lp/mm (Proposed Device)
DQE (Detective Quantum Efficiency) (Typ. @0.1lp/mm)	No specific acceptance criteria stated for improvement over predicate, but higher is generally better.	Typ.78% (Proposed Device) vs. Typ.72% (Predicate Device)
MTF (Modulation Transfer Function) (Typ. @0.5lp/mm)	No specific acceptance criteria stated for improvement over predicate.	Typ.84% (Proposed Device) vs. Typ.89% (Predicate Device) (Note: Proposed device is lower but "no differences in performance as a result of performing the clinical test" is claimed)
Electrical Safety	Compliance with ES60601-1	Complies
EMC	Compliance with IEC 60601-1-2	Complies
Software Validation	Developed per FDA guidance (MODERATE level of concern)	Verified and Validated
Biocompatibility	Compliance with ISO 10993-1	Complies
Cybersecurity	Compliance with FDA guidance	Addressed

2. Sample size used for the test set and the data provenance

The text does not provide details on the sample size used for any clinical test set or the provenance (e.g., country of origin, retrospective/prospective) of the clinical data. It only states that "Clinical data has been provided according to FDA guidance document".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The text does not provide this information.

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

The text does not provide this information.

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

The text does not mention or describe an MRMC comparative effectiveness study or any AI assistance. The device is a "Flat Panel Digital X-ray Detector," not an AI-powered diagnostic tool.

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

The text does not mention or describe a standalone algorithm performance study. The device itself is an X-ray detector, not an algorithm.

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

The text does not provide this information. It only generally states "clinical data has been provided."

8. The sample size for the training set

The text does not provide this information as it does not describe an AI model or a training set.

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

The text does not provide this information as it does not describe an AI model or a training set.

Summary

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February 16, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

LG Electronics Inc. % Mr. Dogyun Im Senior Researcher GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul, 03909 KOREA

Re: K214044

Trade/Device Name: 14HQ901G-B Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: December 17, 2021 Received: December 27, 2021

Dear Mr. Im:

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 Assistant Director Diagnostic X-ray Team 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) K214044

Device Name 14HQ901G-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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K214044

510(k) Summary

[As Required by 21 CFR 807.92]

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

December 15, 2021

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	14HQ901G-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:	K183286
●	Applicant:	LG Electronics Inc.
●	Trade/Device Name:	17HK701G-W
●	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)]

The Flat Panel Digital X-ray Detector 14HQ901G-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.

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

The Flat Panel Digital X-ray Detector 14HQ901G-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 14HQ901G-B and the predicate devices:

	Proposed Device	Predicate Device	Note
K Number	Not known	K183286
Manufacturer	LG Electronics Inc.	LG Electronics Inc.	Same
Trade Name	14HQ901G-B	17HK701G-W	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 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.	Flat Panel Digital X-ray Detector17HK701G-W is indicated for digitalimaging solution designed for generalradiographic system for humananatomy. It is intended to replacefilm or screen based radiographicsystems in general purposediagnostic procedures all and not tobe used for mammography.	Same
Detector
Scintillator	CsI	CsI	Same
Imaging Area	14 x 17 inches	17 x 17 inches	Different
Pixel Matrix	2,560 x 3,072 pixels	3,060 x 3,060 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.72% @0.1lp/mm	Different
MTF	Typ.84% @0.5lp/mm	Typ.89% @0.5lp/mm	Different
Resolution	3.6lp	3.6lp	Same
Anatomical Sites	General	General	Same
Exposure Mode	Manual, Auto (AED)	Manual, Auto (AED)	Same
Semi Dynamicmode	O	×	Different
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,' "Pixel matrix,' 'MTF,' 'DQE' and 'semi dynamic mode.' Imaging area and pixel matrix are not related to the device's 'safety and 'performance.' And proposed device has different 'DQE' and 'MTF' compared with

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

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	Proposed Device	Predicate Device	Note
	the predicate device. But there are no differences in performance as a result ofperforming the clinical test. Semi Dynamic mode is a function that can transmit fiveimages per second to the PC. But this function does not affect the safety andperformance of the subject device. So Proposed device (14HQ901G-B) and PredicateDevice (17HK701G-W) are substantially same.

There are no significant differences between the 14HQ901G-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, 14HQ901G-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.

The technological characteristics of the subject detector 14HQ901G-B are similar to the predicate 17HK701G-W, and the only major difference is the larger detector size.

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9. Non-Clinical Test summary

The 14HQ901G-B comply with voluntary standards for electrical safety, electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:

Electrical Safety, Electromagnetic Compatibility and Performance:

The 14HQ901G-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 14HQ901G-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 Manaqement of Cybersecurity in Medical Devices, on December 28, 2016 ●

Label

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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 Sate 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 14HQ901G-B and the predicate device, K182348 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 14HQ901G-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.