GU60A & GU60A-65 by Samsung Electronics Co.,Ltd.

The GU60A & GU60A-65 Digital X-ray Imaging Systems are 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 GU60A & GU60A-65 digital X-ray imaging systems are to be used to take and store image for diagnosis of patients. It consists of HVG(High voltage generator), U-arm positioner, Detector, X-ray tube, Collimator, AEC(Auto Exposure Control), DAP(Dose Area Product), CIB(Control Interface Box), Remote controller, Grid, Barcode scanner and Autostitching stand.

These systems are 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 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 GU60A & GU60A-65 digital X-ray imaging systems is stationary, and it was previously cleared under K151685. The software features cleared with K171119, SimGrid, BSI (Bone Suppression Image) and TLE (Tube & Line Enhancement), is added to the predicate x-ray system (K151685).

The software features called as SimGrid, BSI (Bone Suppression Image) and TLE (Tube & Line Enhancement) is a post-image processing software option which provides companion images to assist diagnosis in addition to the images obtained from normal diagnosis protocol.

The SimGrid software option is able to compensate the contrast loss due to scatter radiations, primarily acquisitions without a physical anti-scatter grid.

The BSI software option suppresses bone anatomy and the TLE software option enhances visibility of tube and catheter features in a companion image that is delivered in addition to the original diagnostic image.

These software features are designed to be exclusively installed in S-station, SAMSUNG digital X-ray operation software, while it uses the radiological image as an input and do not depend on how the image is acquired or which radiology device is used.

AI/ML Overview

The provided document does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or reported device performance metrics in the format requested. The document is a 510(k) premarket notification summary for an X-ray imaging system, focusing on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's an analysis of what can be extracted:

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

Acceptance Criteria: Not explicitly stated in the provided text. The document refers to conformance with various 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 62220-1) and a guidance document for wireless technology. It also states that all test results were "satisfying the standards." However, specific numerical acceptance criteria for performance (e.g., sensitivity, specificity, accuracy) for the software features are not detailed.
Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the device, or its software features (SimGrid, BSI, TLE). It only mentions that MTF and DQE measurements "show no difference in non-clinical testing data... from the predicate device."

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

Not specified. The document states "The application of SimGrid, TLE, S-DAP and BSI, cleared with K171119, to the proposed device GU60A & GU60A-65 does not require clinical data." This implies no clinical test set was used for the substantial equivalence demonstration of these specific software features. Non-clinical testing data (MTF and DQE) likely used phantoms, but the sample size or provenance of that data is not provided.

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 as no clinical data or specific test set adjudicated by experts is described in the document.

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

Not applicable as no clinical data or specific test set with expert adjudication is described 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 MRMC comparative effectiveness study is mentioned. The document explicitly states that clinical data was not required for the software features in question.

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

The document implies that the software features (SimGrid, BSI, TLE) provide "companion images to assist diagnosis." This suggests an assistive role rather than a standalone diagnostic role, but no specific performance metrics for this assistance are provided. The fact that clinical data was not required for these features further supports that a standalone performance study was not conducted for this submission.

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

Not applicable, as no clinical studies with established ground truth are described for the performance of the features. For non-clinical MTF and DQE measurements, the ground truth would be determined by the phantom properties and measurement protocols per IEC 62220-1.

8. The sample size for the training set

Not specified. The document describes the device as a hardware system with added post-processing software features. There is no mention of an "AI" or "machine learning" algorithm in the modern sense that would require a distinct training set. The software features (SimGrid, BSI, TLE) are described as "post-image processing software option" rather than adaptive learning algorithms.

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

Not applicable, as a training set for an AI/ML algorithm is not described.

Summary

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January 12, 2018

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

Re: K173828

Trade/Device Name: GU60A, GU60A-65 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: December 19, 2017 Received: December 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);

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silv er Spring, MD 20993 w ww.fda.qov

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K173828

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 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) K173828

Device Name GU60A, GU60A-65

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) Premarket Notification - Traditional

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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 : November 30, 2017

2. Submitter

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

3. Primary Contact Person

Name: Jaesang NOH & ChulSin Kim A.
B. Title: Regulatory Affairs Manager
ပ Phone Number: +82-31-200-1764 & +82-31-200-7661
D. FAX Number: +82-31-200-6401 E-Mail: jaesang.noh@samsung.com & chulsin.kim@samsung.com_

4. Secondary Contact Person

A. Name: Ninad Gujar
B. Title: Director, Regulatory & Quality
Phone Number: 978-564-8503 ပ
FAX Number: 978-750-6677 D.
- E-Mail: ngujar@samsungneurologica.com

5. Proposed Devices

Trade Names: GU60A & GU60A-65 A.
B. Device Names: GU60A & GU60A-65
Common Name: Digital Diagnostic X-ray System ﻥ
Regulation Name: Stationary X-ray system D.
Requlation: 21 CFR 892.1680 ய்
ட் Product Code: KPR

Predicate Device 6.

	Predicate Device #1	Predicate Device #2
Device Name	GU60A & GU60A-65	GM85
Classification Name	Stationary X-ray System	Mobile X-ray System
Product Code	KPR	IZL
Regulation	21 CFR 892.1680	21 CFR 892.1720
510(K)#	K151685	K171119
510(K) Decision Date	July 17, 2015	May 12, 2017

Device Description 7.

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510(k) Premarket Notification - Traditional

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used for reading images.

The SimGrid software option is able to compensate the contrast loss due to scatter radiations, primarily acquisitions without a physical anti-scatter grid.

8. Intended Use

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

The proposed device GU60A & GU60A-65 apply a post-image processing software feature as SimGrid, TLE (Tube & Line Enhancement), S-DAP and BSI (Bone Suppression lmage), which was cleared with K171119, to GU60A-65 product which were cleared with K151685 without changes in technical characteristics, materials, energy sources and biocompatibility such as X-ray Tube Assembly and Detectors except of high voltage generator. Optional high voltage generator is added to GU60A model.

Comparisons of technological characteristics were executed and demonstrate the substantial equivalence to the predicates.

Comparing with Predicate Device #1 and #2 A.

The proposed device is shown as its parts are identical or equivalent with predicate device #1 or #2 while the software features called as SimGrid, BSI, TLE and S-DAP are applied, which does not show significant difference in safety and effectiveness.

ManufacturerContents	Predicate Device#1	Proposed Device	Predicate Device#2
Device Name	GU60A & GU60A-65	GU60A & GU60A-65	GM85
Manufacture	Samsung	Samsung	Samsung
510(k) Number	K151685		K171119

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510(k) Premarket Notification - Traditional

Appearance				Same as PD#1
	Image: X-ray machine	Image: X-ray machine	Image: Mobile X-ray machine
Intended Use	The GU60A &GU60A-65 DigitalX-ray ImagingSystems areintended for use ingeneratingradiographicimages of humananatomy by aqualified/traineddoctor ortechnician. Thisdevice is notintended formammographicapplications.	The GU60A &GU60A-65 DigitalX-ray ImagingSystems areintended for use ingeneratingradiographicimages of humananatomy by aqualified/traineddoctor ortechnician. Thisdevice is notintended formammographicapplications.	The GM85 DigitalMobile X-rayimaging System isintended for use ingeneratingradiographicimages of humananatomy by aqualified/traineddoctor ortechnician. Thisdevice is notintended formammographicapplications.	Same as PD#1

ManufacturerContents	Predicate Device#1	Proposed Device	Predicate Device#2	Discussion
High voltage generator
Model	GU60A	GU60A	-	Same as PD#1
Phase	3 phase	3 phase	-	Same as PD#1
Frequency	50/60 Hz	50/60 Hz	-	Same as PD#1
Line voltage±10%	400/480 VAC	400/480 VAC±10%	-	Same as PD#1
Power rating	50kW	50kW 68kW	-	Difference(1)
kV range	40 ~ 150 kV	40 ~ 150 kV	-	Same as PD#1
mA range	10 ~ 630 mA	10 ~ 800 mA	-	Difference(2)
Time range	1.0 ms ~ 6.3sec	1.0 ms ~ 10sec	-	Difference(3)

ManufacturerContents	Predicate Device#1	Proposed Device	Predicate Device#2	Discussion
Software Feature
BSI	-	BSI	BSI	Same as PD#2
SimGrid	-	SimGrid	SimGrid	Same as PD#2

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510(k) Premarket Notification - Traditional

Tube & LineEnhancement(TLE)	-	TLE	TLE	Same as PD#2
S-DAP	-	S-DAP	S-DAP	Same as PD#2
S-Share	S-Share	S-Share	S-Share	Same

No	Differences	Explanation
(1)	Power rating	Optional HVG which is added to the GU60A device hashigher max power than the predicate device's max powerand the higher max power does not contribute anyadverse impact to the device's safety and effectiveness.
(2)	mA range	Optional HVG which is added to the GU60A device hashigher max current than the predicate device's maxcurrent and the higher max current does not contributeany adverse impact to the device's safety andeffectiveness.
(3)	Time range	Optional HVG which is added to the GU60A device haslonger max time than the predicate device's max timeand the longer max time does not contribute any adverseimpact to the device's safety and effectiveness.

B. 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.

C. 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 devices show no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device.

Clinical data D.

The application of SimGrid, TLE, S-DAP and BSI, cleared with K171119, to the proposed device GU60A & GU60A-65 does not require clinical data.

E. Conclusions
Non-clinical data demonstrates that the proposed devices are as safe, as effective, and perform as well as the legally marketed predicate devices.

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.