The GC80 Series 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 GC80 digital X-ray imaging system consists of High voltage generator (HVG), Ceiling Suspension, X-ray tube, Collimator, Detector, AEC, DAP, CIB(Control Interface Box), Wall Stand, Patient Table, Collimator, Detector, Remote controller, Grid, Foot switch, Barcode scanner and Auto-stitching stand. This 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 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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the SAMSUNG ELECTRONICS Co., Ltd. Digital Diagnostic X-ray System (GC80). It primarily focuses on demonstrating substantial equivalence to a predicate device (XGEO GC80) and does not detail specific acceptance criteria and a study dedicated to proving the device meets those criteria in the typical sense of a novel AI/CAD device.

Instead, the submission for the GC80 X-ray system focuses on confirming that its performance, despite the addition of a new detector, remains consistent with established medical device standards and is substantially equivalent to a previously cleared device. Therefore, the "acceptance criteria" here are effectively the performance standards met by the predicate device and relevant international/national standards, and the "study" is a comparative assessment.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria for specific diagnostic performance metrics (e.g., sensitivity, specificity for disease detection) that would be common for AI/CAD devices.
Instead, it focuses on the equivalence of technical specifications and image quality. The implicit acceptance criteria are that the device performs as well as the predicate device and meets relevant international standards.

Acceptance Criteria Category (Implicit)	Reported Device Performance (GC80)
Image Quality (Non-clinical)	MTF (Modulation Transfer Function) and DQE (Detective Quantum Efficiency) curves and measurements do not differ from the predicate device (XGEO GC80) when tested by IEC 62220-1. This indicates equivalent image quality at the physical detector level.
Image Quality (Clinical)	Radiologists evaluated the images of GC80 as substantially equivalent, and superior in some images, to the predicate device.
Safety and Performance Standards	Electrical, mechanical, environmental safety and performance testing according to 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. EMC testing was conducted in accordance with IEC 60601-1-2:2007. Wireless function was tested and verified followed by guidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfying the standards. This indicates compliance with recognized safety and performance standards for X-ray systems.
Technological Characteristics	The GC80, despite adding new detectors (S4343-W, S3025-W), maintains substantially equivalent technological characteristics to the predicate XGEO GC80 (K140334) across various components including High Voltage Generator, Ceiling Suspension, Wall Stand, Patient Table, and Collimator, as detailed in the comparative tables on pages 5-7. Key identical specs include max power (80kW), kV/mA/exposure time ranges, AEC, APR, mechanical movement ranges, brake locking, control types, etc. The differences in detector area and number of pixels are stated to not impact safety or performance because pixel pitch and type are identical.
Intended Use	Identical intended use as the predicate device: "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."

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

Sample Size for Clinical Data: The document states, "Clinical images were provided," but it does not specify the sample size (number of images or patients) used for this clinical evaluation.
Data Provenance: Not explicitly stated in terms of country of origin or whether it was retrospective/prospective. Given "Clinical images were provided," it implies a retrospective collection of existing images for evaluation.

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)

The document states, "In clinical data, the radiologists evaluate the image of GC80 is substantially equivalent, and superior in some images to the predicate device."
Number of experts: Not specified (plural "radiologists" suggests more than one).
Qualifications of experts: Not specified beyond "radiologists."

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

The document does not specify an adjudication method. It only mentions that "radiologists evaluate the image."

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, an MRMC comparative effectiveness study was not done. This submission is for an X-ray system, not an AI/CAD device. The "clinical data" involved radiologists evaluating the images themselves, not evaluating AI output or comparing their performance with and without AI. Therefore, there's no discussion of human reader improvement with AI assistance.

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

Not applicable. This device is an X-ray imaging system, not an AI algorithm. Its performance is inherent in its ability to generate radiographic images, not in its interpretation.

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

For the clinical evaluation, the "ground truth" for the image quality assessment was the expert evaluation of radiologists. The goal was to confirm that the images generated by the GC80 were of comparable, or superior, quality for diagnostic purposes as those from the predicate device.

8. The sample size for the training set

Not applicable / Not specified. As this is an X-ray imaging system and not an AI/CAD device, there is no "training set" in the context of machine learning. The system's performance is based on its hardware and software engineering meeting physical and technical standards.

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

Not applicable. See point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare. The caduceus in the logo is depicted with three intertwined strands.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 9, 2015

SAMSUNG ELECTRONICS Co., Ltd. % Chulsin Kim Regulatory Affairs Manager 129, Samsung-ro, Yeongtong-gu Suwon-si, Gyeonggi-do 443-742 REPUBLIC OF KOREA

Re: K143029

Trade/Device Name: Digital Diagnostic X-ray System (GC80) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: January 6, 2015 Received: January 8, 2015

Dear Chulsin Kim:

This letter corrects our substantially equivalent letter of February 4, 2015.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K143029

Device Name GC80

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)X 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 Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"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."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The font is bold and sans-serif, and the letters are evenly spaced. The oval is tilted slightly upwards from left to right.

510(k) Premarket Notification - Traditional

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: January 6, 2015
1. Submitter
- A. Company Name: SAMSUNG ELECTRONICS Co., Ltd.
- B. Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-742, Republic of Korea

3. Primary Contact Person

Name: KIM, CHULSIN A.
B. Title: Regulatory Affairs Manager
C. Phone Number: +82-31-200-7661
D. FAX Number: +82-31-200-1199 E-Mail: chulsin.kim@samsung.com

4. Secondary Contact Person

A. Name: Donald D. Fickett
B. Title: Vice President Regulatory & Quality Assurance
C. Phone Number: 978-564-8523
D. FAX Number: 978-750-6677 E-Mail: dfickett@samsungneurologica.com

5. Identification Device

A. Trade Name: GC80
B. Device Name: GC80
C. Common Name: Digital Diagnostic X-ray System
Classification Name: System, X-ray, Stationary D.
ட். Product Code: KPR
F. Regulation: 21 CFR 892.1680

Predicate Device 6.

Manufacturer: SAMSUNG ELECTRONICS Co., Ltd. A.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold, sans-serif font. The word is placed on a blue, oval-shaped background.

510(k) Premarket Notification - Traditional

Trade Name: XGEO GC80 B.
ட். Classification Name: System, X-ray, Stationary
D. Product Code: KPR
டப் 510(k) Number: K140334
510(k) Decision Date: May 28, 2014 F.

7. Device Description

This 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 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.

8. Intended Use

The GC80 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.

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

The GC80 adds new detectors to the predicate device, and it does not have significant change in materials, energy source or technological characteristics compared to the predicate device, XGEO GC80 (K140334). Comparisons of the following technological characteristics were assessed and the results demonstrate the substantial equivalence to the predicates.

Specification	Predicate Device	Proposed Device	Discussion
Device Name	XGEO GC80	GC80
Manufacturer	SAMSUNG ELECTRONICS	SAMSUNG ELECTRONICS

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the SAMSUNG logo. The logo is in a blue oval shape. The word "SAMSUNG" is written in white letters inside the oval.

510(k) Premarket Notification - Traditional

510(k) Number	K140334	N/A
Appearances			Same
Intended Use	The XGEO GC80 digital X-ray imaging system isintended for use ingenerating radiographicimages of human anatomyby a qualified/trained doctoror technician. This device isnot intended formammographic applications.	The GC80 digital X-rayimaging system is intendedfor use in generatingradiographic images ofhuman anatomy by aqualified/trained doctor ortechnician. This device is notintended for mammographicapplications.	Same

Manufacturer Contents	XGEO GC80(K140334)	GC80	Discussion
(1)High Voltage Generator
Type	High Frequency	High Frequency	Same
Max. Power	80kW	80kW	Same
OutputRANGE	Tube Voltage	40-150kV	40-150kV	Same
	Tube Current	10-1000mA	10-1000mA	Same
	Exposure Time	1msec-6.3sec	1msec-6.3sec	Same
AEC(Automatic Exposure Control)	Yes	Yes	Same
APR (AnatomicallyProgrammed Radiography)	Yes	Yes	Same

Manufacturer Contents	XGEO GC80(K140334)	GC80	Discussion
(2)Ceiling Suspension
MovingRange(mm)	Longitudinal	1680~4180(Varies with roomsize)	1680~4180(Varies with roomsize)	Same
	Lateral	1030~3030(Varies with roomsize)	1030~3030(Varies with roomsize)	Same

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the Samsung logo. The logo is in a blue oval shape. The word "SAMSUNG" is written in white letters inside the oval.

510(k) Premarket Notification - Traditional

Manufacturer Contents		XGEO GC80(K140334)	GC80	Discussion
	Vertical	1840	1840	Same
Vertical Tube Moving method		Motorized	Motorized	Same
Tube Assembly Rotation		$-157 ~ +183$	$-157 ~ +183$	Same
Brake locking Method		Electromagnetic	Electromagnetic	Same
Automatic Centering		O	O	Same
Moving Rail Type		Al Extrusion	Al Extrusion	Same
Image Preview		O	O	Same
Display Type		Color LCD	Color LCD	Same
Control Switch Type		Button+ Touch Screen	Button+ Touch Screen	Same
Vertical Sync.	With Table	O	O	Same
	With Stand	O	O	Same

Manufacturer Contents			XGEO GC80(K140334)	GC80	Discussion
(3) Wall Stand
	VerticalMovement	Mechanism	Motorized/Manual	Motorized/Manual	Same
		Range(mm)	400~1800	400~1800	Same
Detector/tube servo coupling			Yes	Yes	Same
Detector	Tilting	Mechanism	Motorized	Manual	Same
		Range	-20~+90	-20~+90	Same
AEC			Conventional	Conventional	Same
Grid		Lines/cm	84.6	84.6	Same
		Gridmechanism	Stationary	Stationary	Same

		Removability	Removable	Removable	Same
Detector Support Mounting			Floor	Floor	Same
Patient Support Device			Patient handgrips,lateral support bar	Patient handgrips,lateral support bar	Same

Manufacturer Contents	XGEO GC80(K140334)	GC80	Discussion
(4)Patient Table
Table Top	Size(mm)	2410 X 812	2410 X 812	Same

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue oval shape.

510(k) Premarket Notification - Traditional

	Manufacturer Contents		XGEO GC80(K140334)	GC80	Discussion
	Rangee(mm)	LateralLongitudinal	±140±480	±140±480	Same
Tableheight	Mechanism		DC Motor, Ball screw	DC Motor, Ball screw	Same
	Range(mm)		545 ~ 900	545 ~ 900	Same
Horizontal range of detector(mm)			590	590	Same
AEC			Conventional	Conventional	Same
	Lines/cm		84.6	84.6	Same
Grid	Grid mechanism		Stationary	Stationary	Same
	Removability		Removable	Removable	Same
Vertical Sync.			O	O	Same
	Control Switch Type		Foot switch	Foot switch	Same
Maximum Patient Weight(kg)			350(Static, Center load)	350(Static, Center load)	Same

Manufacturer Contents	XGEO GC80(K140334)	GC80	Discussion
(5)Collimator
Overall Size(mm)	H212 X W300X D179	H212 X W300X D179	Same
Beam Limiting BladeMoving Method	Motorized/Manual	Motorized/Manual	Same
Manual Operation Method	Volume	Volume	Same
Collimator Rotation	$ \pm $ 45	$ \pm $ 45	Same
Beam Light Source	LED	LED	Same
Light Field Indicator Timer	O	O	Same
Side Lamp	O	O	Same
Field Size / SID Display	Laser ModuleColor LCD	Laser ModuleColor LCD	Same

ManufacturerContents	XGEO GC80 (K140334)	GC80	Discussion
*NOTE: S3025-W detector as an option is added in the list of detectors used for XGEO GC80(K140334)

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue, oval shape.

510(k) Premarket Notification - Traditional

ManufacturerContents	XGEO GC80 (K140334)	GC80	Discussion
(6) Detector
Name	S4335-W	S4343-W	S3025-W
	Csl	Csl	Csl
Detector Type	Indirect	Indirect	Indirect
Detector Area	14"X17"(345mmX425mm)	17"X17"(425mmX425mm)	10"X12"(245mmX295mm)
Number of pixels	2466X3040	3036X3040	1750X2108
Pixel Pitch(um)	140	140	140
High ContrastLimitingResolution(LP/mm)	3.57	3.57	3.57
Communication	Wired / Wireless	Wired / Wireless	Wired / Wireless

No	Differences	Explanation
(1)	Detector Area	Proposed medical device's detector has smaller area than the predicate device's detectors while technical specification is identical among them such as type & pixel pitch, and the smaller area does not contribute any adverse impacts to the predicate device's safety and performance.
(2)	Number of pixelsResolution and pixel pitchof detector	Proposed medical device's detector has smaller detector area. Therefore, the proposed medical device's numbers of pixels is smaller than the predicate device's detectors while pixel pitch is identical among them, and the smaller number of pixels does not contribute any adverse impacts to the predicate device's safety and performance.

In non-clinical data, the propose detector shows curves and measurements of MTF and DQE that do not differ from the predicate device.

In clinical data, the radiologists evaluate the image of GC80 is substantially equivalent, and superior in some images to the predicate device.

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

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold, sans-serif font. The word is set against a blue, oval-shaped background.

510(k) Premarket Notification - Traditional

conducted in accordance with standard IEC 60601-1-2:2007. 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

In non-clinical data, MTF and DQE were tested and measured by IEC 62220-1. The proposed device shows no different curves and measurements of MTF and DQE from the predicate device.

12. Clinical data

Clinical images were provided; these images were not necessary to establish substantial equivalence but they provide further evidence in addition to the laboratory performance data to show that the whole system works as intended.

13. Conclusions

The non-clinical and clinical data demonstrates that the proposed device is as safe, as effective, and performs as well as the legally marketed device identified in paragraph 6.

1. Samsung Electronics Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA

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.