XGEO GU60A by SAMSUNG ELECTRONICS CO., LTD.

The XGEO GU60A 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 GU60A 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 the acceptance criteria or a study that proves the device meets specific performance criteria beyond general safety and effectiveness.

Here's an analysis of what is and isn't present in the document based on your request:

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

The document states that "Non-clinical testing and Clinical Testing were conducted in accordance with Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" and that "All test results are satisfied."
It also mentions differences from the predicate device in "pixel pitch, high contrast limiting resolution, DQE, MTF and communication," noting that the proposed device has higher DQE and MTF values. These are performance metrics, but no specific acceptance criteria or quantitative performance results are provided in a table.

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

This information is not provided in the document.

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)

This information is not provided in the document.

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

This information is not provided in the document.

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

The text describes a digital X-ray imaging system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

As the device is an X-ray imaging system and not an algorithm for diagnosis, standalone algorithm performance is not applicable and not mentioned. The device produces images for a qualified/trained doctor or technician to interpret.

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

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document. The device is a hardware imaging system, not a machine learning algorithm that requires a training set in the typical sense.

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

This information is not provided as it's not an AI/ML device in the context of requiring ground truth for a training set.

Summary of available information related to acceptance criteria and device performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (XGEO GU60A, K123106) by highlighting that observed differences in technical specifications (pixel pitch, high contrast limiting resolution, DQE, MTF, communication) do not negatively impact safety or effectiveness.

Acceptance Criteria (Implicit/General):
- Compliance with various electrical, mechanical, environmental safety, and performance standards (ES 60601-1:2012, IEC 60601-1-3:2008, IEC 60601-2-28:2010, IEC 60601-2-54:2009, 21CFR1020.30, 21CFR1020.31, IEC 60601-1-2:2007).
- Compliance with "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" for non-clinical and clinical testing.
- No new potential safety risks compared to the predicate device.
- Performance "as well as" the predicate device despite differences in certain technical specifications.
- The proposed device has "higher DQE value" and "higher MTF value" compared to the predicate, implying improvement in image quality.
Reported Device Performance:
- "All test results are satisfied" (in reference to the listed standards and guidance documents).
- The device has a different (likely smaller, leading to higher resolution) pixel pitch.
- Higher high contrast limiting resolution (due to pixel pitch).
- Higher DQE value (affects image quality).
- Higher MTF value (affects image quality).
- Supports both wired and wireless communication (predicate only wired).

No specific quantitative acceptance criteria or detailed results of performance studies are presented in this 510(k) summary beyond the general statement that all tests were satisfied and the device performs at least as well as the predicate, with some technical improvements.

Summary

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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 : Feb. 7, 2014
1. Submitter
- Company Name: SAMSUNG ELECTRONICS Co., Ltd. A.
- B. Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-742, Republic of Korea

3. Primary Contact Person

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

4. Secondary Contact Person

Name: Ha, Aeyoung A.
B. Title: Regulatory Affairs Manager
C. Phone Number: +82-31-200-1537
FAX Number: +82-31-200-1199 D.
ட். E-Mail: ay.ha@samsung.com

5. Device

Trade Name: XGEO GU60A A.
Common Name: Digital Diagnostic X-ray System B.
். Classification Name: System, X-ray, Stationary
D. Product Code: KPR

6. Device Description

The XGEO GU60A 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,

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510(k) Premarket Notification - Traditional

Detector, X-ray tube, Collimator and etc.

7. Intended Use

8. Comparison with predicate device

Samsung Electronics Co., Ltd., believes that the proposed XGEO GU60A is substantially equivalent to XGEO GU60A (K123106).

The proposed XGEO GU60A adds a new detector(S4343-W). Through the comparison with the predicate device, it is proved that both devices are same or similar in many ways, but differences in five items were found. Specifically, differences in pixel pitch, high contrast limiting resolution, DQE, MTF and communication exist, but they are considered to have minor impacts on the safety and performance.

1. Pixel pitch: Pixel pitch, which is a measurement that indicates the distance between pixels and determines an image resolution, is different. It affects the image quality but it has no effect on safety.
1. 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 no effect on safety.
1. DQE: The value of DQE is different. The detector of the proposed device has higher DQE value. It affects the image quality but it has no effect on safety.
1. MTF: The value of MTF is different. The detector of the proposed device has higher MTF value. It affects the image quality but it has no effect on safety.
1. Communication: The proposed device can interface with an external device through the wired and wireless communication methods, while the predicate device supports only the wired one. This difference has no effect on safety.

The above differences do not have an effect on safety and effectiveness compared with the predicate device, XGEO GU60A (K123106).

In summary, the XGEO GU60A does not introduce any new potential safety risks and is

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510(k) Premarket Notification - Traditional

substantially equivalent to and performs as well as the predicate device. In conclusion, the XGEO GU60A is substantially equivalent to XGEO GU60A (K123106).

9. Safety, EMC and Performance Data

Electrical, mechanical, environmental safety and performance testing according to standard ES 60601-1:2012, IEC 60601-1-3:2008, IEC 60601-2-28:2010, IEC 60601-2-54:2009, 21CFR1020.30 and 21CFR1020.31 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2:2007. And Non-clinical testing and Clinical Testing were conducted in accordance with Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" (issued August 6, 1999). All test results are satisfied.

10. 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 GU60A is safe and effective and substantially 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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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 circle with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol in the center is a stylized representation of a human figure embracing a globe.

Public Health Service

Food and Drue Administration 10903 New Hampshire Avenue Document Control Center - WO66-G619 Silver Spring, MD 20093-0002

May 28, 2014

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

Re: K140332

Trade/Device Name: XGEO GU60A Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: April 25, 2014 Received: April 28, 2014

Dear Aeyoung Ha:

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 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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Page 2-Aeyoung Ha

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" (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 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.

Sincerely yours,

Smh7)

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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510(k) Premarket Notification - Traditional

510(k) Number (if known): K140332

Device Name: XGEO GU60A

Indications for Use:

The XGEO GU60A Digital X-ray Imaging System is intended for use in generaling radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

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

Over-The-Counter Use_ (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sm. 7)

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