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 a stationary x-ray system designed for general radiography and 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 on the S-station, which is the Operation Software (OS) of Samsung Digital Diagnostic X-ray System, and save in DICOM file, a standard for medical imaging. The captured images are tuned up by an Image Postprocessing Engine (IPE) which is exclusively installed in S-station, and sent to the Picture Archiving, Communication System (PACS) sever for reading images.

The GU60A, GU60A-65 digital X-ray imaging systems consist of HVG (High Voltage Generator), U-arm positioner, X-ray tube, collimator, detector, ACE (Auto Exposure Control), DAP (Dose Area Product), CIB (Control Interface Box), remote controller, grid, barcode scanner, auto-stitching stand, weight distribution cap and workstation for Sstation including Image Post-processing Engine (IPE).

The difference between GU60A and GU60A-65 is that the option of their HVG is different. In detail, 50 kW and 68 kW are for GU60A and 65 KW is for GU60A-65.

The GU60A, GU60A-65 digital X-ray imaging systems were previously cleared under K180543, and some hardware options and three software features are added to the predicate device GU60A, GU60A-65. The changes are as follows:

Two detectors
Software features called as S-Enhance, PEM (Pediatric Exposure Management) and Remote View
- The S-Enhance is optional software to improve clarity of a foreign body (e.g. tube, line) and stone in chest, abdomen and L-spine images. With a single onscreen click, the companion image is created without additional settings or xray exposure, streamlining the process.
- Pediatric Exposure Management is subdivided patient size and exposure conditions especially for pediatric patients based on weight and protocols. It follows same methodologies to define preset of patient size compare to preset of standard patient size from predicate device but specially optimized for pediatric patients.
- The Remote view function provided images on another PC, not just on the device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the GU60A and GU60A-65 Digital X-ray Imaging Systems. It details the device, its intended use, and comparisons to predicate devices. However, the document does not contain any information about acceptance criteria or a study proving the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity for a particular clinical task.

The document states:

"Non-clinical data demonstrates that the proposed devices are as safe, as effective, and perform as well as the legally marketed predicate devices."
"The application of detectors and software features, cleared with K181629, to the proposed device GU60A, GU60A-65 does not require clinical data."
"The verification and validation for the software features added to the proposed device were also conducted and reviewed in accordance with internal design change procedure. As a result, requirement specifications were met and the proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device."

This implies that the acceptance was primarily based on:

Substantial equivalence to predicate devices: The new features (S-Enhance, PEM, Remote View, and new detectors) were already cleared with previous predicate devices (K180543 and K181629).
Compliance with non-clinical performance and safety standards: Electrical, mechanical, environmental safety, EMC, and X-ray specific performance (MTF, DQE measurements) were conducted according to relevant IEC and FDA standards (e.g., ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30, 21CFR1020.31).
Software verification and validation: Conducted according to internal design change procedures.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets clinical performance acceptance criteria because the provided text explicitly states that clinical data was not required for this 510(k) submission.

The document focuses on demonstrating substantial equivalence to pre-existing, cleared devices and adherence to engineering and non-clinical performance standards for X-ray imaging systems. It does not describe a study involving an AI component with specific performance metrics (like accuracy for a diagnostic task) and associated acceptance criteria that would typically involve human-in-the-loop studies, multi-reader multi-case studies, or expert ground truth adjudication.

If the question is implicitly asking about the "acceptance criteria" and "study" in the context of the entire X-ray system meeting regulatory clearance, then the answer is based on "substantial equivalence" and compliance with non-clinical performance and safety standards, as detailed in the document, rather than a clinical performance study for a specific diagnostic AI feature.

Based solely on the provided text, and understanding that it does not describe a clinical performance study for an AI component's diagnostic accuracy:

I cannot populate the requested table and answer many of the specific questions because the document does not contain the necessary information about a clinical performance study or diagnostic AI acceptance criteria. The submission is for a general radiographic imaging system and an enhancement software (S-Enhance) for clarity of foreign bodies/stones, but without specifying diagnostic performance metrics or a study to prove them.

Here's what can be inferred or stated based on the text's lack of this information:

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

Acceptance Criteria (Diagnostic Performance)	Reported Device Performance (Diagnostic Performance)
Not specified in the document	Not specified in the document
(No clinical performance acceptance criteria or results are provided)	(The document states "does not require clinical data" for the changes)

The document's acceptance criteria related to safety and general performance are:

Compliance with electrical, mechanical, environmental safety standards (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).
Compliance with EMC testing (IEC 60601-1-2).
Compliance with wireless function guidance.
Conformity to FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices" for non-clinical data (MTF and DQE measurements).
Software verification and validation meeting "requirement specifications" in accordance with internal design change procedure.

The reported device performance in these areas is that "All test results were satisfying the standards" and "requirement specifications were met and the proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements 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)

Sample Size: Not applicable/Not specified, as no clinical test set for diagnostic performance was described. The non-clinical performance data (MTF, DQE) would use physical phantoms or test objects, not patient data in the typical sense of a test set for AI.
Data Provenance: Not applicable/Not specified.

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/Not specified, as no clinical test set or ground truth establishment process for diagnostic performance was described.

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

Not applicable/Not specified, as no clinical test set or adjudication process was described.

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

Was an MRMC study done? No. The document states "The application of detectors and software features... does not require clinical data."
Effect size: Not applicable.

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

Not applicable/Not specified, as no standalone diagnostic performance study for an AI algorithm was described. The S-Enhance is described as "optional software to improve clarity," which suggests image processing, not a standalone diagnostic AI.

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

Not applicable/Not specified, as no clinical ground truth for diagnostic performance was described. For non-clinical validation (MTF, DQE), the "ground truth" would be the known physical properties of the test phantoms.

8. The sample size for the training set

Not applicable/Not specified, as no information about an AI training set is provided.

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

Not applicable/Not specified, as no information about an AI training set or its ground truth establishment is provided.

Summary

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

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

Re: K182622

Trade/Device Name: GU60A, GU60A-65 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: September 21, 2018 Received: September 24, 2018

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. 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 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

October 23, 2018

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

Digitally signed by Mich Michael D DN: c=US. o=U.S. Government HHS. ou=EDA. ou=People O'hara -S 2342.19200300.100.1.1=1300 6759, cn=Michael D. O'hara -S FOI Date: 2018.10.23 17:42:12 -04'00"

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K182622

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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Image /page/3/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white letters on a blue oval background. The oval is tilted slightly to the right.

510(k) Premarket Notification - Special

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: September 21, 2018

2. Submitter

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

3. Primary Contact Person

A. Name: JAESANG NOH, CHUNSIN KIM
B. Title: Regulatory Affairs, Senior Professional
C. Phone Number: +82-2-2193-2444, +82-2-2193-2437
D. FAX Number: +82-31-200-6401
E. E-Mail: jaesang.noh@samsung.com, chulsin.kim@samsung.com

4. Secondary Contact Person

A. Name: Genci Omari
B. Title: Manager, Regulatory Affairs
C. Phone Number: 978-564-8602
D. FAX Number: 978-560-0602
E-Mail: gomari@samsungneurologica.com ப்

5. Proposed Devices

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

6. Predicate Device

	Predicate Device #1(Primary Predicate)	Predicate Device #2
Device Name	GU60A, GU60A-65	GC85A
Classification Name	Stationary X-ray System	Stationary X-ray System
Product Code	KPR	KPR
Regulation	21 CFR 892.1680	21 CFR 892.1680
510(K)#	K180543	K181629
510(K) Decision Date	May 24,2018	July 20, 2018

7. Device Description

The GU60A, GU60A-65 digital X-ray imaging systems are a stationary x-ray system

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Image /page/4/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue rounded rectangle.

510(k) Premarket Notification - Special

designed for general radiography and 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 on the S-station, which is the Operation Software (OS) of Samsung Digital Diagnostic X-ray System, and save in DICOM file, a standard for medical imaging. The captured images are tuned up by an Image Postprocessing Engine (IPE) which is exclusively installed in S-station, and sent to the Picture Archiving, Communication System (PACS) sever for reading images.

The difference between GU60A and GU60A-65 is that the option of their HVG is different. In detail, 50 kW and 68 kW are for GU60A and 65 KW is for GU60A-65.

Two detectors
Software features called as S-Enhance, PEM (Pediatric Exposure Management) and Remote View
- The S-Enhance is optional software to improve clarity of a foreign body (e.g. tube, line) and stone in chest, abdomen and L-spine images. With a single onscreen click, the companion image is created without additional settings or xray exposure, streamlining the process.
- Pediatric Exposure Management is subdivided patient size and exposure conditions especially for pediatric patients based on weight and protocols. It follows same methodologies to define preset of patient size compare to preset of standard patient size from predicate device but specially optimized for pediatric patients.
- The Remote view function provided images on another PC, not just on the device.

8. Intended Use

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.

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

The proposed device GU60A, GU60A-65 do not alter the intended use or the fundamental scientific technology and remains within the same classification regulation for the same intended use as the predicate devices #1 and 2 because the proposed device GU60A,

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510(k) Premarket Notification - Special

GU60A-65 use the same detectors and the same software features called as S-Enhance, PEM and Remote View of the predicate device GC85A, which were cleared with K181629, as a selective option of X-ray configuration. Verification and validation testing for these changes were successfully conducted in accordance with Samsung Design Change Process.

The following tables compare the main technological characteristics of the proposed device with the predicate devices to substantiate equivalence.

A. Comparing with Predicate Devices

The components and software features added to the proposed device are identical to the predicate devices, which do not show significant difference in safety and effectiveness.

ManufacturerContents	Predicate Device#1(PrimaryPredicate)	Proposed Device	Predicate Device#2	Discussion
Device Name	GU60A, GU60A-65	GU60A, GU60A-65	GC85A
Manufacture	Samsung	Samsung	Samsung
510(k)Number	K180543		K181629
Appearance	Image: X-ray machine	Image: X-ray machine	Image: X-ray machine	Same as PD#1
Intended Use	The GU60A,GU60A-65 DigitalX-ray ImagingSystems areintended for usein generatingradiographicimages of humananatomy by aqualified/traineddoctor ortechnician. Thisdevice is notintended formammographicapplications.	The GU60A,GU60A-65 DigitalX-ray ImagingSystems areintended for usein generatingradiographicimages of humananatomy by aqualified/traineddoctor ortechnician. Thisdevice is notintended formammographicapplications.	The GC85Adigital X-rayimaging systemis intended foruse in generatingradiographicimages of humananatomy by aqualified/traineddoctor ortechnician. Thisdevice is notintended formammographicapplications	Same as PD#1
ManufacturerContents	Predicate Device#1	Proposed Device	Predicate Device#2	Discussion
(1) Detectors (Note: All detectors were 510(k) cleared with predicate #1, #2)

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Image /page/6/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 - Special

Name(ModelNumber)	S4335-WS4343-WS3025-W	S4335-WS4343-WS3025-WS4335-AWS4343-AW	S4335-AWS4343-AW	S4335-AWS4343-AW	S4335-WS4343-W	S4335-AWS4343-AW	Same as PD#2
Detector Type	CslIndirect	CslIndirect	CslIndirect	CslIndirect	CslIndirect	CslIndirect	SameSame
Detector Area	14"X17"(345mmX425mm)	17"X17"(425mmX425mm)	14"X17"(345mmX425mm)	17"X17"(425mmX425mm)	14"X17"(345mmX425mm)	17"X17"(425mmX425mm)	SameSame
Number ofpixels	2466X3040	3036X3040	2466X3040	3036X3040	2466X3040	3036X3040	SameSame
Pixel Pitch(um)	140	140	140	140	140	140	Same
High ContrastLimitingResolution(LP/mm)	3.57	3.57	3.57	3.57	3.57	3.57	Same
Communication	Wired /Wireless	Wired /Wireless	Wired /Wireless	Wired /Wireless	Wired /Wireless	Wired /Wireless	Same
Dust/Water-resistance	IPx1		IP54		IP54		Same as PD#2
Max.loadcapacity	150 kg for uniformload,100 kg for localload (40 mm indiameter disk atthe center)		400 kg for uniformload,200 kg for localload (40 mm indiameter disk atthe center)		400 kg for uniformload,200 kg for localload (40 mm indiameter disk atthe center)		Same as PD#2

ManufacturerContents	Predicate Device#1	Proposed Device	Predicate Device#2	Discussion
(2) Software Feature
FeatureNames	SimGrid	SimGrid	SimGrid	Same
	-	-	S-Guide	N/A
	TLE	S-Enhance	S-Enhance	Same as PD#2
	-	PEM	PEM	Same as PD#2
	S-DAP	S-DAP	S-DAP	Same
	S-Share	S-Share	S-Share	Same
	BSI	BSI	BSI	Same
	-	Remote View	Remote View	Same as PD#2

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

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510(k) Premarket Notification - Special

verified followed by guidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfying the standards.

ﻥ 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 verification and validation for the software features added to the proposed device were also conducted and reviewed in accordance with internal design change procedure. As a result, requirement specifications were met and the proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device.

D. Clinical data

The application of detectors and software features, cleared with K181629, to the proposed device GU60A, GU60A-65 does not require clinical data.

Conclusions ய்

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.