The XGEO GU60 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 XGEO GU60 digital X-ray imaging system is to be used to take and store image for diagnosis of patients. It consists of the High voltage generator (HVG), U-arm positioner, Detector, X-ray tube, Collimator and etc.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria for device performance, nor does it describe a study that explicitly proves the device meets such criteria through quantitative performance metrics. This document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance beyond general safety and effectiveness standards.

However, based on the information provided, here's what can be gathered regarding safety and performance testing:

Key Takeaways from the Document:

Focus on Substantial Equivalence: The primary goal of this 510(k) submission is to assert that the XGEO GU60 is "substantially equivalent" to predicate devices (Revolution XR/d and Diamond-5A). This means demonstrating that it is as safe and effective as commercially available devices.
Compliance with Standards: The document states that electrical, mechanical, environmental safety, and performance testing was conducted according to various IEC and CFR standards (e.g., IEC 60601-1, IEC 60601-1-3, IEC 60601-2-54, 21CFR1020.30, 21CFR1020.31). EMC testing adhered to IEC 60601-1-2(2001).
Non-Clinical and Clinical Testing: It mentions that "Non-clinical testing and Clinical Testing were conducted in accordance with Solid-state X-ray Imaging System Guidance. All test results were satisfied." However, no details about these tests, their methodology, or specific acceptance criteria are provided.
Image Quality Differences with No Safety Impact: The document transparently lists differences between the XGEO GU60 and its predicate devices in aspects like detector type (phosphor), number of pixels, pixel pitch, high contrast limiting resolution, DQE, and MTF. Crucially, it asserts that these differences "affect the image quality but it has not effect on safety" and "do not have an effect on safety and efficiency compared with the predicate device." This implies that while there might be differences in image quality characteristics, they were considered within an acceptable range for safety and intended use.

Regarding the specific questions, most of the requested information is not present in this 510(k) summary:

Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided. The summary states that "All test results were satisfied" for various standards, but it does not specify the quantitative acceptance criteria for device performance (e.g., specific thresholds for spatial resolution, contrast detectability, or dose) or the numerical results achieved by the XGEO GU60.
- Implied Acceptance Criteria: The implicit acceptance criterion for this 510(k) is "substantial equivalence" to the predicate devices and compliance with the safety and performance standards cited. This means the device performed within the accepted ranges defined by those standards and was deemed to not introduce new safety risks or reduce effectiveness compared to the predicates.
Sample Size used for the Test Set and Data Provenance: Not specified in the document.
Number of Experts used to establish the Ground Truth for the Test Set and Qualifications: Not specified in the document. The mention of "Clinical Testing" implies human involvement, but no details are given.
Adjudication Method for the Test Set: Not specified.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned or implied. The focus is on the device itself and its equivalence, not on human reader performance with or without AI assistance.
Standalone Performance Study: The document implicitly discusses standalone performance through its comparison of technical specifications (DQE, MTF, resolution) with predicate devices and its statement that "all test results were satisfied" for non-clinical and clinical testing. However, a dedicated study specifically labeled as "standalone" with detailed metrics is not described. The document largely speaks to the inherent capabilities of the device in comparison to its predicates.
Type of Ground Truth Used: Not specified. For an X-ray imaging system, ground truth for image quality often involves phantom studies (non-clinical) and potentially clinical image review against established diagnostic criteria or other imaging modalities (clinical). The document only broadly mentions "Non-clinical testing and Clinical Testing."
Sample Size for the Training Set: Not applicable as this document describes a traditional X-ray imaging system, not an AI/machine learning device that would require a "training set."
How the Ground Truth for the Training Set was Established: Not applicable (see point 8).

In conclusion, this 510(k) summary primarily focuses on regulatory compliance and demonstrating substantial equivalence through adherence to recognized standards and a component-level comparison to predicate devices, rather than providing detailed quantitative performance studies with specific acceptance criteria and outcome metrics that would be expected for an AI-powered device or a more novel technology.

Summary

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SAMSUNG ELECTRONICS Co., Ltd.

510(k) Premarket Notification - Traditional

510(k) Summary

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JUN 0 7 2013

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

1. Date: Sep. 20, 2012
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: Charlie Mack A.
B. Title: President of International Regulatory Consultants
C. Phone Number: 541-376-5063
FAX Number: 541-376-5063 D.
E-Mail: charliemack@irc-us.com ய்

4. Secondary Contact Person

A. Name: Shim, Kyungam
Title: Regulatory Affairs Manager B.
C. Phone Number: +82-31-200-3356
FAX Number: +82-31-200-0700 D.
ட. E-Mail: kyungam.shim@samsung.com

5. Device

Trade Name: XGEO GU60 A.
B. Common Name: Digital Diagnostic X-ray System
C. Classification Name: System, X-ray, Stationary
D. Product Code: KPR

6. Predicate Device

Manufacturer: DRGEM Corporation A.
B. Trade Name: Diamond-5A
C. 510(k) Number: K102408

2 / 5

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SAMSUNG ELECTRONICS Co., Ltd.

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510(k) Premarket Notification - Traditional

D. 510(k) Decision Date: 2010 Dec 27
র্ব Manufacturer: General Electric Company
B. Trade Name: Revolution XR/d Digital Radiographic Imaging System
C. 510(k) Number: K012389
D. 510(k) Decision Date: 2001 Aug 10

7. Device Description

8. Intended Use

Comparison with predicate device : 9.

Samsung Electronics Co., Ltd., believes that the XGEO GU60 is substantially equivalent to the Revolution XR/d of General Electric Company and Diamond-5A of DRGEM Corp.

Comparison with the predicate device made through the system component items such as detector, generator etc., has been proven to be similar in many ways, but differences in the seven items were found. Specifically, even if the differences of the capacity and size of High Voltage Generator, Ceiling Suspension, Wall stand and Patient table exists, these are considered minor impact on the safety and performance. Also, Collimator, Detector, and Image Process Function in terms of the design and the technology characteristic have differences in the following characteristics:

Blade moving method: Motorized method for adjusting a collimator radiation field is only available. It just concerns on the method for control a radiation field and has not effect on safety.
Detector type : Phosphor of detector is different. Two major scintillation materials such as Gd2O2S and Csl are commonly used. It affects the image quality but it has not effect on safety.
Number of pixels : Number of pixels is different. A detector with a large number of

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SAMSUNG ELECTRONICS Co., Ltd.

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510(k) Premarket Notification - Traditional

pixels can cover a wider area of body. It has not effect on safety. (Difference from Revolution XR/d Digital Radiographic Imaging System of General Electric Company, but Similarities to DIAMOND-5A of DRGEM Corporation)

Pixel pitch : Pixel pitch, a measurement that indicates the distance between pixels and determines an image resolution, is different. It affects the image quality but it has not effect on safety.
High contrast limiting resolution : High contrast limiting resolution is different due to the difference of the pixel pitch. The resolution is higher as the value of the pixel pitch is lower. It affects the image quality but it has not effect on safety.
DQE : The value of DQE is different. The detector type with CSI phosphor has higher DQE value. It affects the image quality but it has not effect on safety.
MTF : The value of MTF is different. The detector type with CSI phosphor has higher MTF value. It affects the image quality but it has not effect on safety.

However, these differences do not have an effect on safety and efficiency compared with the predicate device, Revolution XR/d of General Electric Company and Diamond-5A of DRGEM Corp ..

In summary, the XGEO GU60 does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.

In conclusion, the XGEO GU60 is substantially equivalent to Revolution XR/d of General Electric Company and Diamond-5A of DRGEM Corp ..

10. Safety, EMC and Performance Data :

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, IEC 60601-2-54, 21CFR1020.30 and 21CFR1020.31 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2(2001). And Non-clinical testing and Clinical Testing were conducted in accordance with Solidstate X-ray Imaging System Guidance. All test results were satisfied.

11. Conclusions :

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Samsung Electronics Co., Ltd. concludes that The XGEO GU60 is safe and effective and substantially

4 / 5

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SAMSUNG ELECTRONICS Co., Ltd.

510(k) Premarket Notification - Traditional equivalent to predicate devices as described herein.

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

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an abstract human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The symbol is composed of three angled lines that converge to form the shape of a person, with the wordmark surrounding the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

June 7, 2013

SAMSUNG ELECTRONICS Co., Ltd. % Mr. Charlie Mack Principal Engineer International Regulatory Consultants 77325 Joyce Way ECHO OR 97826

Re: K123105

Trade/Device Name: XGEO GU60 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: May 21, 2013 Received: May 29, 2013

Dear Mr. Mack:

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, Ilisting 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 forth in the quality systems (QS) 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/Safetv/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.

Sincerely yours,

Smh.P)

for

Janine M. Morris 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): K123105

Device Name: XGEO GU60

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Sm.h.7)

(Division Sign-Off) Division of Radiological Health Office of In Viro Diagnostics and Radiological Health

K123105 510(k)

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Regulation Number and Section

N/A