The GM85 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 GM85 Digital Mobile X-ray imaging System is the equipment that captures 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 Bone Suppression Image (BSI) 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 BSI software option suppresses bone anatomy to enhance visualization of chest pathology in a companion image that is delivered in addition to the original diagnostic image.

The BSI option is designed to be exclusively installed in S-station, SAMSUNG digital Xray 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 text describes a 510(k) premarket notification for the GM85 Digital X-ray imaging System, specifically focusing on the integration of the Bone Suppression Image (BSI) feature. However, the document explicitly states that the application of BSI to the proposed device does not require clinical data and therefore, clinical studies to establish acceptance criteria or device performance are not detailed within this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical data and technical characteristics, rather than presenting a performance study with acceptance criteria.

Therefore, many of the requested details about acceptance criteria and the study that proves the device meets them cannot be extracted from this particular submission.

Here's what can be inferred and what is explicitly stated as not applicable or not provided:

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

Acceptance Criteria: Not explicitly stated in terms of clinical performance metrics (e.g., sensitivity, specificity, AUC). The acceptance criteria for this submission appear to be focused on substantial equivalence to predicate devices through technical comparisons and non-clinical testing.
Reported Device Performance: No clinical performance metrics are reported because clinical data was deemed not required and thus not provided. The performance is assessed based on the device having the same detectors and therefore showing "no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device #1 and #2."

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

Sample Size: Not applicable/not provided. No clinical test set.
Data Provenance: Not applicable/not provided. No clinical test data.

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

Number of Experts: Not applicable/not provided. No clinical test set.
Qualifications of Experts: Not applicable/not provided.

4. Adjudication method for the test set

Adjudication method: Not applicable/not provided. No clinical test set.

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

MRMC Study: No. The document explicitly states "The application of BSI... to the proposed device GM85 does not require clinical data." Therefore, an MRMC study was not performed for this submission.
Effect Size: Not applicable/not provided.

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

Standalone Performance: Not explicitly detailed as a performance study for the BSI feature itself. The BSI software option "provides companion images to assist diagnosis," implying it's an aid, not a standalone diagnostic tool without a human. However, its verification and validation were done through a "Software System Test Case" (non-clinical).

7. The type of ground truth used

Type of Ground Truth: Not applicable for a clinical performance study. For the BSI software's non-clinical verification and validation, the ground truth would be against expected software output based on its design specifications, rather than clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

Sample Size for Training Set: Not applicable/not provided. The document focuses on performance relative to predicate devices and non-clinical validation. Details regarding the training of the BSI algorithm itself are not included in this submission.

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

Ground Truth for Training Set: Not applicable/not provided as training set details are not included.

Summary of what is provided regarding acceptance and study:

The acceptance for this 510(k) submission is based on demonstrating substantial equivalence to predicate devices. This is achieved through:

Technical Characteristics Comparison: Showing that the proposed device (GM85 with BSI) is identical or equivalent to Predicate Device #1 (GM85 without BSI, K162278) in its core components (HVG, X-ray Tube Assembly, Detectors) and shares the BSI feature with Predicate Device #2 (GC70 with BSI, K163115).
Safety, EMC, and Performance Data (Non-clinical):
- Electrical, mechanical, environmental safety, and performance testing according to 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).
- EMC testing according to IEC 60601-1-2.
- Wireless function testing according to guidance on "Radio frequency Wireless Technology in Medical Devices."
- All these tests "were satisfying the standards."
Non-clinical Data for Imaging Performance:
- Conformance to 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.
- The proposed device uses the same detectors as the predicate devices, "so it shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device #1 and #2."
Software Verification and Validation: "BSI installed in S-Station of GM85 has been verified and validated through GM85 Software System Test Case." (This is a non-clinical, internal software validation).

Conclusion from the document: "The non-clinical demonstrates that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate devices."

The critical point for this document is that the FDA determined, and the submission reflects, that for the integration of the already cleared BSI software into the GM85 mobile X-ray system, no new clinical data was required to demonstrate substantial equivalence.

Summary

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Public Health Service

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

May 12, 2017

Samsung Electronics Co., Ltd. % Chulsin Kim Regulatory Affairs Manager 129, Samsung-ro, Yeongtong-gu Suwon-si. 16677 Gveonggi-do REPUBLIC OF KOREA

Re: K171119

Trade/Device Name: GM85 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL. MOB Dated: April 7, 2017 Received: April 14, 2017

Dear Chulsin Kim:

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

Image /page/0/Picture/11 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 three human profiles facing right, stacked on top of each other, forming a single abstract shape.

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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/ResourcesforYou/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,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K171119

Device Name GM85

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

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: April 7, 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: ChulSin Kim
B. Title: Regulatory Affairs Manager
Phone Number: +82-31-200-7661 ﻥ
FAX Number: +82-31-200-1199 D. E-Mail:chulsin.kim@samsung.com

4. Secondary Contact Person

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

5. Proposed Device

A. Trade Name: GM85
B. Device Name: GM85
C. Common Name: Digital Diagnostic Mobile X-ray System
D. Classification Name: Mobile X-ray System
Product Code: IZL & MQB ட்
ட் Regulation: 21 CFR 892.1720

6. Predicate Devices

	Predicate Device #1	Predicate Device #2
Device Name	GM85	GC70
ClassificationName	MobileX-ray system.	StationaryX-ray System
Product Code	IZL	KPR
Regulation	21 CFR 892.1720	21 CFR 892.1680
510(K)#	K162278	K163115
510(K) Decision Date	November 15, 2016	December 07, 2016

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510(k) Premarket Notification - Traditional

7. Device Description

8. Intended Use

The GM85 Digital Mobile 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 devices

The proposed device GM85 applies a post-image processing software feature as BSI (Bone Suppression Image), which was cleared with K163115, to the predicate device GM85 (K162278) without changes in technical characteristics, materials, energy sources and biocompatibility such as High Voltage Generator(HVG), X-ray Tube Assembly and Detectors.

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

A. Comparing with Predicate Device #1 and #2

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

Specification	Predicate Device #1	Proposed Device	Predicate Device #2
DeviceName	GM85	GM85	GC70
Manufacture	SAMSUNG	SAMSUNG	SAMSUNG
	ELECTRONICS co., ltd.	ELECTRONICS co., ltd.	ELECTRONICS co., ltd.
510(k)Number	K162278	-	K163115

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510(k) Premarket Notification - Traditional

Appearances	Image: Samsung GM85 Digital Mobile X-ray	Image: Samsung GM85 Digital Mobile X-ray	Image: GC70 Digital X-ray Imaging System	Same asPD#1
IntendedUse	The GM85 DigitalMobile X-ray imagingSystem is intended foruse in generatingradiographic images ofhuman anatomy by aqualified/trained doctoror technician. Thisdevice is not intendedfor mammographicapplications.	The GM85 DigitalMobile X-ray imagingSystem is intended foruse in generatingradiographic images ofhuman anatomy by aqualified/trained doctoror technician. Thisdevice is not intendedfor mammographicapplications.	The GC70 Digital X-rayImaging System isintended for use ingenerating radiographicimages of humananatomy by aqualified/trained doctoror technician. Thisdevice is not intendedfor mammographicapplications.	Same asPD#1

Manufacturer Contents	Predicate Device #1	Proposed DeviceGM85	Predicate Device#2	Discussion
Software Feature
SimGrid	SimGrid	SimGrid	SimGrid	Same asPD#1
Tube & LineEnhancement(TLE)	TLE	TLE	-	Same asPD#1
Pediatric ExposureManagement(PEM)	PEM	PEM	-	Same asPD#1
S-DAP	S-DAP	S-DAP	S-DAP	Same
S-Align	S-Align	S-Align	S-Align	Same asPD#1
S-Share	S-Share	S-Share	S-Share	Same
BSI	-	BSI	BSI	Same asPD#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 verified followed by guidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfying the standards.

C. Non-clinical data

Non-clinical 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 device has same detectors so it shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device #1 and #2. BSI installed in S-Station of GM85 has been verified and validated through GM85

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510(k) Premarket Notification - Traditional Software System Test Case.

D. Clinical data

The application of BSI, cleared with K163115, to the proposed device GM85 does not require clinical data.

E. Conclusions

The non-clinical demonstrates that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate devices.

Regulation Number and Section

§ 892.1720 Mobile x-ray system.

(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.