The XGEO 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.

Device Description

The XGEO GC80 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), Ceiling suspension, Detector, X-ray tube, Patient table, Wall stand, Collimator and etc.

AI/ML Overview

The provided text describes the Samsung XGEO GC80, a digital X-ray imaging system, and its 510(k) premarket notification. However, the document does not contain specific acceptance criteria, a detailed study description, or performance data in the format requested.

It primarily focuses on establishing substantial equivalence to a predicate device (General Electric Company's Revolution XR/d) by comparing technical characteristics and outlining safety, EMC, and general performance testing against regulatory standards.

Therefore, I cannot fulfill all parts of your request with the input provided. Below is a summary of what can be extracted and what cannot.

Summary of Device Acceptance Information (Based on Provided Text):

The document largely focuses on demonstrating substantial equivalence to a predicate device and adherence to general safety and performance standards for an X-ray system. It does not present a detailed study with specific acceptance criteria and performance metrics for a novel algorithm or diagnostic aid in the way a clinical performance study would.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as specific performance targets (e.g., sensitivity, specificity, accuracy) for image interpretation. The "acceptance criteria" here implicitly refer to meeting established safety and performance standards relevant to X-ray systems and demonstrating substantial equivalence to a predicate device.
- Implicit Acceptance Criteria:
  - Compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32 (Electrical, mechanical, environmental safety and performance).
  - Compliance with IEC 60601-1-2(2001) (EMC testing).
  - Demonstration that differences from the predicate device do not introduce new safety risks or negatively impact performance.
  - Resolution of detector being "higher than that of the predicate device" for high contrast, which is considered "more advantageous."
  - Image stitching functionality providing "more efficiency" for long areas of anatomy without affecting safety.
Reported Device Performance:
- "All test results were satisfactory" for the safety, EMC, and performance testing against the listed IEC standards.
- The high contrast resolution of the XGEO GC80's detector is reported to be "higher than that of the predicate device," which is deemed "more advantageous."
- The device is concluded to be "safe and effective and substantially equivalent to predicate devices."

2. Sample Size Used for the Test Set and Data Provenance:

Not provided. The document does not describe a clinical test set or patient data used to evaluate a diagnostic algorithm's performance. The testing mentioned pertains to engineering, safety, and physical performance of the X-ray system itself.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable/Not provided. This information would be relevant for evaluating a diagnostic AI algorithm's performance against expert-derived ground truth. The presented text describes a traditional X-ray system, not an AI-powered diagnostic device requiring such expert evaluation in this context.

4. Adjudication Method for the Test Set:

Not applicable/Not provided. As no clinical test set or expert ground truth establishment is described, an adjudication method is not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The document does not describe an MRMC study comparing human reader performance with and without AI assistance. This device is a diagnostic imaging system, not an AI-assisted interpretation tool.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Not applicable/Not provided. The XGEO GC80 is an X-ray imaging system, not a standalone AI algorithm. It produces images for human interpretation.

7. The Type of Ground Truth Used:

Not applicable/Not provided. For the system's performance, the "ground truth" corresponds to meeting engineering specifications and regulatory standards via physical tests, rather than a clinical ground truth like pathology or patient outcomes for a diagnostic algorithm.

8. The Sample Size for the Training Set:

Not applicable/Not provided. This information is relevant for machine learning or AI models. This document describes an X-ray system, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable/Not provided. As no training set or AI algorithm is mentioned, this information is not relevant to the document.

In summary: The provided 510(k) summary focuses on demonstrating that the Samsung XGEO GC80 X-ray system is substantially equivalent to a legally marketed predicate device through engineering and regulatory compliance testing. It does not detail a clinical study with acceptance criteria and results related to diagnostic performance as would be expected for an AI-enabled medical device.

Summary

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Image /page/0/Picture/0 description: The image shows the word "SAMSUNG" in bold, capital letters. Above the word "SAMSUNG" is the alphanumeric string "K123098". The text is black and the background is white.

SAMSUNG ELECTRONICS Co., Ltd.

510(k) Premarket Notification - Traditional

510(k) Summary

JAN 1 8 2013

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

Date: Sep. 20, 2012 1.
Submitter 2.
- Company Name: SAMSUNG ELECTRONICS Co., Ltd. A.
- Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-742, B.
- Republic of Korea

Primary Contact Person

Name: Charlie Mack A.
Title: President of International Regulatory Consultants B:
Phone Number: 541-376-5063 C.
D. · FAX Number: 541-376-5063
E-Mail: charliemack@irc-us.com ய

Secondary Contact Person

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

Device 5.

Trade Name: XGEO GC80 A.
B. Common Name: Digital Diagnostic X-ray System
Classification Name: System, X-ray, Stationary ்.
Product Code: KPR

Predicate Device 6.

Manufacturer: General Electric Company A.
Trade Name: Revolution XR/d Digital Radiographic Imaging System
510(k) Number: K012389 : :

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SAMSUNG ELECTRONICS Co., Ltd.

510(k) Premarket Notification - Traditional

.. ...

D. 510(k) Decision Date: 2001 Aug 10

7. Device Description

Intended Use

9. Comparison with predicate device:

The XGEO GC80 described in this 510(k) has the same intended use and similar technical characteristics as the Revolution XR/d of General Electric Company.

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:

Collimator Rotation: Rotation angles are different but not affect safety. THU head can be rotated to cover ±90. It has not effect on efficiency and safety since the coverage of the angle is the same.
Beam light source: Beam light source do not affects safety. LED is more advanced beam light source than Halogen Lamp since it produce low power consumption and good durability. It has not effect on efficiency and safety
Resolution of detector. Resolution of detector is different. That affects the image quality but has not an effect on safety. The high contrast resolution of the device has higher than that of the predicate device that is more advantageous.
Image Stitching: The XGEO GC80 has the image stitching functionality but not the Revolution XR/d. It has more efficiency since this device can be also used for examinations of long areas of anatomy such as the leg and spine. Also, it has not an

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SAMSUNG ELECTRONICS Co., Ltd.

510(k) Premarket Notification - Traditional

effect on safety since it just produces long length images of subjects by moving a 17 x 17 inch Detector up and down along the Receptor and takes up to 4 images, and transfers these multiple images to the Workstation console and stitch multiple images by image processing on the console.

SAMSUNG

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

In summary, the XGEO GC80 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 GC80 is substantially equivalent to Revolution XR/d of General Electric Company.

Safety, EMC and Performance Data: 10.

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 and IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2(2001). All test results were satisfactory.

Conclusions : 11.

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 GC80 is safe and effective and substantially equivalent to predicate devices as described herein.

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

January 18, 2013

Samsung Electronics Co., Ltd c/o Mr. Charlie Mack Principal Engineer 77325 Joyce Way ECHO OR 97826

Re: K123098

Trade/Device Name: XGEO GC80 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-ray Systems Regulatory Class: II Product Code: KPR Dated: December 30, 2012 Received: January 15, 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, 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

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Page 2-Mr. Mack

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 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/Industry/default.htm.

Sincerely vours.

Sean M. Boyd -S for

Janine 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): K123098

Device Name: XGEO GC80

Indications for Use:

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

Over-The-Counter Use (21 CFR 807 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)

Sean M. Boyd -S

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K123098 510(k) __

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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.