GC85A by Samsung Electronics Co.,Ltd.

The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

Device Description

The GC85A digital X-ray imaging system is used to capture images by transmitting X-ray to a patient's body. The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process device before being sent to the S-Station (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images.

The Image Post-processing Engine is exclusively installed in S-station, which is a Samsung Digital X-ray Operation Software for Samsung Digital X-ray System. It has an image processing algorithm to improve an acquired image and previously cleared with K160997.

The proposed Image Post-processing Engine is upgraded with employing an advanced noise reduction algorithm to improve image quality. The proposed Engine is shown of a post-processed image as substantially equivalent as the image by the predicate Image Post-processing Engine at a certain low dose level.

AI/ML Overview

The acceptance criteria and the study proving the device meets them are detailed below, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The device is an upgraded Image Post-processing Engine for the GC85A Digital X-ray Imaging System, featuring an advanced noise reduction algorithm. The primary acceptance criterion is achieving substantially equivalent image quality at a 50% reduced radiation dose compared to the predicate device.

Acceptance Criterion	Reported Device Performance
Image quality substantially equivalent to predicate device with 50% dose reduction (for PA radiograph for average adult chest).	Phantom study: Images using the proposed engine, taken at 50% reduction in radiation dose, are substantially equivalent to those using the predicate engine. Clinical study: Images using the proposed engine taken at 50% reduction in radiation dose are substantially equivalent to those using the predicated engine without sacrificing diagnostic confidence.
Improved image quality (noise reduction, distinction between background and object, clarity)	SNR and CNR measured to determine image quality showed overall images using the proposed engine make it easy to distinguish between background and the object and is clearer than images using the predicated engine.
Maintained diagnostic confidence	Clinical study confirmed that diagnostic confidence was not sacrificed with the 50% dose reduction images.
Conformance to safety and performance standards (Electrical, mechanical, environmental, EMC, wireless function)	All test results were satisfying the standards: ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30, 21CFR1020.31, IEC 60601-1-2. Wireless function tested and verified.
Conformance to FDA guidance for Solid-State X-ray Imaging Devices (MTF and DQE measurements)	Non-clinical testing data provided in conformance to the FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices," including MTF and DQE measurements as tested by IEC 62220-1.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size:
- Clinical Study: 78 in-vivo data sets of chest PA images.
- Phantom Study: Not explicitly stated as a number, but "a semi-anatomical chest phantom at a various radiation dose" and "anthropomorphic chest phantom images" were used.
Data Provenance: The clinical study was conducted at "one facility" and involved "in-vivo data sets." This implies the data is prospective clinical data collected specifically for this study. The country of origin is not explicitly mentioned but the submitter is from the Republic of Korea.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Three professional radiologists.
Qualifications: "Three experienced radiologists." Specific years of experience are not provided, but they are described as "professional" and "experienced."

4. Adjudication Method for the Test Set

The text mentions that "Anthropomorphic chest phantom images were scored by Bureau of Radiological Health (BRH) method and inter-observer agreement was calculated."
For the clinical images, "Seven anatomical landmarks were evaluated for image quality assessment by three readers."
While it states that inter-observer agreement was calculated for phantom images and multiple readers evaluated clinical images, it does not explicitly describe a specific adjudication method like 2+1 or 3+1 for resolving discrepancies in reader interpretations for either phantom or clinical studies. It implies a consensus or agreement was sought, but the formal process isn't detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A MRMC study comparing human readers with AI vs. without AI assistance was not conducted. The study evaluated whether images processed by the new engine at reduced dose were substantially equivalent to those from the predicate engine, evaluating the device's standalone performance in producing equivalent diagnostic images, rather than its assistive role to humans.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone evaluation of the algorithm's output was critically performed. The primary goal was to demonstrate that the images generated by the new Image Post-processing Engine at 50% dose reduction are diagnostically equivalent to those from the predicate device at full dose. This means the algorithm's ability to process images to an acceptable diagnostic quality was the focus, rather than its interaction with a human reader. SNR and CNR measurements and the radiologists' evaluations of image quality were direct assessments of the algorithm's output.

7. The Type of Ground Truth Used

The ground truth was established through expert consensus/reader interpretation (three experienced radiologists) during the evaluation of both anthropomorphic phantom images (scored by BRH method) and clinical images (evaluation of seven anatomical landmarks and 18 cases of featured lung lesions). There is no mention of pathology or outcomes data being used as ground truth.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for the training set used to develop or train the advanced noise reduction algorithm in the Image Post-processing Engine.

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

The document does not provide information on how the ground truth for the training set was established. It focuses primarily on the testing and validation of the device's performance.

Summary

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November 22, 2017

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Samsung Electronics Co.,Ltd. % Jaesang NOH Regulatory Affairs 129, Samsung-ro, Yeongtong-gu Suwon-si. Gyeonggi-do. 16677 REPUBLIC OF KOREA

Re: K172229

Trade/Device Name: GC85A Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: October 19, 2017 Received: October 20, 2017

Dear Jaesang NOH:

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone

(1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara

For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K172229

Device Name GC85A

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D) ] Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Type of Use (Select one or both, as applicable)

PRAStaff@fda.hhs.gov

Form Approved: OMB No. 0910-0120

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510(k) Premarket Notification - Traditional

Section 5: 510(k) Summary

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

1. Date: July 20, 2017

2. Submitter

Company Name: SAMSUNG ELECTRONICS Co., Ltd. A.
Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16677, B. Republic of Korea

3. Primary Contact Person

A. Name: NOH, Jaesang
B. Title: Regulatory Affairs
Phone Number: +82-31-200-1764 ﻥ
FAX Number: +82-31-200-6401 D. E-Mail: jaesang.noh@samsung.com

4. Secondary Contact Person

A. Name: Ninad Gujar
B. Title: Regulatory Affairs Manager
C. Phone Number: 978-564-8503
FAX Number: 978-750-6677 D. E-Mail: ngujar@samsungneurologica.com

5. Proposed Device

A. Trade Name: GC85A
B. Device Name: GC85A
C. Common Name: Digital Diagnostic X-ray System
D. Classification Name: Stationary X-ray System
Product Code: KPR ட்
ட் Regulation: 21 CFR 892.1680

6. Predicate Devices

Predicate Devices
	Predicate Device
Device Name	GC85A
ClassificationName	Stationary X-raySystem
Product Code	KPR
Regulation	21 CFR 892.1680
510(K)#	K160997
510(K)Decision Date	July 6, 2016

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510(k) Premarket Notification - Traditional

7. Device Description

This submission is intended to get 510(k) clearance for GC85A with the proposed engine by which the substantially equivalent PA radiograph for average adult chest can be taken using the 50% dose reduction for marketing purpose.

This claim is based on a limited study of an anthropomorphic phantom that simulates the x-ray properties of an average size adult, and on a small clinical study at one facility. Only routine PA chest radiography was studied, and results for larger-size adults (body mass index) greater than 30 was not studied to statistical significance. The new GC85A also was not studied with pediatric patients. The clinical site is responsible for determining whether the particular radiographic imaging needs are not impacted by such x-ray dose reduction.

8. Intended Use

9. Summary of Technological characteristic of the proposed device compared with the predicate device

The proposed device, GC85A has the same hardware characteristics as the predicate device (K160997) and includes an upgraded Image Post-processing engine. It does not have significant changes in materials, energy source or technological characteristics compared to the predicate device.

A. Comparing with Predicate Device

	Specification	Predicate Device	Proposed Device	Discussion
	Device Name	GC85A	GC85A	-

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510(k) Premarket Notification - Traditional

Manufacturer	SAMSUNG ELECTRONICSco., ltd.	SAMSUNG ELECTRONICSco., ltd.	-
510(k)Number	K160997	None	-
Intended Use	The GC85A digital X-rayimaging system is intendedfor use in generatingradiographic images ofhuman anatomy by aqualified/trained doctor ortechnician. This device is notintended for mammographicapplications.	The GC85A Digital X-rayImaging System is intendedfor use in generatingradiographic images ofhuman anatomy by aqualified/trained doctor ortechnician. This device is notintended for mammographicapplications.	Same
Image Post-Processing engine
Noisereductionalgorithm	Image Post-processingEngine with a conventionalnoise reduction algorithm	Image Post-processingEngine with an advancednoise reduction algorithm	Different(1)
No	Differences	Explanation
(1)	Image Post-processing Engine with an advanced noise reduction algorithm	The Image Post-processing Engine is upgraded with employing an advanced noise reduction algorithm which optimizes the degree of noise reduction for improvement of image quality according to the noise distribution and the structural information of a digital radiographic image.While the upgraded Image Post-processing Engine is shown a substantially equivalent image and safe as same as the predicate device's one, it can be taken by the 50% dose reduction comparing with the predicate Image Post-processing Engine.

10. Safety, EMC and Performance Data

Electrical, mechanical, environmental safety and performance testing according to standard ES 60601-1,IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30 and 21CFR1020.31 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. Wireless function was tested and verified followed by guidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfying the standards.

11. Non-clinical 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 62220-1.

The proposed Image Post-processing Engine was evaluated with a semi-anatomical chest phantom at a various radiation dose. SNR and CNR were measured to determine image quality with the images taken using the proposed engine or the predicated engine. Overall images using the proposed engine make it easy to distinguish between background and the object and is clearer than images using the predicated engine. The

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510(k) Premarket Notification - Traditional

qualitative side including usefulness was validated by a radiographer using clinical images which was proved in 'Clinical data' section.

12. Clinical data

Phantom image evaluations were performed in accordance with FDA guidance for the submission of 510(k)'s for Solid State X-ray Imaging Devices. They were evaluated by professional radiologists and found to be equivalent to the predicate device.

The proposed engine was validated with anthropomorphic chest phantom images and clinical images by three professional radiologists. Anthropomorphic chest phantom images were scored by Bureau of Radiological Health (BRH) method and inter-observer agreement was calculated. Clinical image evaluations were performed to support phantom study results under the patient informed consent. Total 78 in-vivo data set of chest PA images were evaluated by three experienced radiologists, covering subject's BMI from 15 to 33. Seven anatomical landmarks were evaluated for image quality assessment by three readers, including 18 cases of featured lung lesions of chest PA images, consolidations, nodules and interstitial markings. The images using the proposed engine taken at 50% reduction in radiation dose are substantially equivalent to those using the predicated engine without sacrificing diagnostic confidence.

13. Conclusions

The non-clinical and clinical data demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed device.

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.