(108 days)
The XGEO GF50 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.
This system is 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 device being sent to the XGEO 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 XGEO GF50 is intended to be used for capturing digital X-ray images of various parts of the body including the head, chest, spine, abdomen, joints, hands, feet and other organs.
The XGEO GF50 is a Digital X-ray Imaging System.
Here's an analysis of its acceptance criteria and the study that proves its performance:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the XGEO GF50 as being "Substantially Equivalent" to a predicate device (XGEO GC80) rather than setting specific numeric acceptance criteria for diagnostic performance. Therefore, the "acceptance criteria" here refer to the demonstration of substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Imaging Performance Equivalence | Images provide equivalent diagnostic capability to predicate device. |
| Non-clinical: Resolution (MTF) | Proposed detector performs better than predicate. |
| Non-clinical: Detective Quantum Efficiency (DQE) | Proposed device has better DQE performance. |
| Safety and Effectiveness | All test results for electrical, mechanical, environmental, EMC, and wireless function were satisfied; device is safe and effective. |
| Intended Use Equivalence | Same as predicate device (generating radiographic images, not mammographic). |
| Technological Characteristics Equivalence | No significant change in materials, energy source, or technological characteristics compared to predicate device. Differences explained and deemed equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The clinical study is referred to as a "concurrence study" but does not detail the number of images or patients used.
- Data Provenance: Not explicitly stated regarding country of origin or specific institutions. It is a "clinical data" study. The document refers to "radiologists in the study" evaluating images of the XGEO GF50 against the predicate device. It is a prospective evaluation comparing the new device's images to a known, established device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated. The document mentions "qualified radiologists" without specifying their number.
- Qualifications of Experts: "Qualified radiologists." Specific experience (e.g., "10 years of experience") is not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The term "concurrence study" suggests that the radiologists evaluated the images to confirm they were diagnostically equivalent, likely reaching a consensus or agreement among themselves. However, the specific method (e.g., 2+1, 3+1, none) is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: The document describes a "concurrence study" where "qualified radiologists" evaluated images for "equivalent diagnostic capability." This implies a comparison against the predicate device, which is a form of comparative effectiveness. However, it's not explicitly labeled as a formal MRMC study, nor does it provide details on the statistical methodology (e.g., comparing reader performance with/without AI assistance, as the device itself is an X-ray system, not primarily an AI diagnostic tool in this context).
- Effect Size: Not applicable/not provided. This device is a digital X-ray system, not an AI-powered diagnostic tool intended to assist or replace human readers. The study aims to show equivalence of the image quality and diagnostic capability produced by the new X-ray system compared to an existing one. Therefore, "how much human readers improve with AI vs. without AI assistance" is not a relevant metric for this type of device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. The XGEO GF50 is a digital X-ray system that produces images for human interpretation, not an algorithm that provides a standalone diagnostic output. The "performance" being evaluated is the diagnostic quality of the images produced by the system. Non-clinical data (MTF, DQE) does provide a form of "standalone" (system-only) technical performance metrics.
7. The Type of Ground Truth Used
- Type of Ground Truth: The clinical study relies on expert consensus/radiologist interpretation for the diagnostic capability of the images. The radiologists "evaluate the image of XGEO GF50 is substantially equivalent to predicate device." This means their clinical assessment of the images from the new device, likely compared to images from the predicate device (or possibly compared to a reference standard diagnosis if provided, though not explicitly stated), formed the "clinical ground truth" for equivalence.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. As an X-ray imaging system, the device does not employ a "training set" in the context of machine learning algorithms for diagnostic output. The system is designed to acquire images, and its performance is evaluated based on the quality of those images as assessed by human experts, and technical specifications.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable, as there is no "training set" for a diagnostic algorithm in this context. The "ground truth" for the device's technical specifications and image quality is established through engineering standards, non-clinical tests (MTF, DQE), and clinical evaluation by radiologists on test images.
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510(k) Premarket Notification - Traditional
SAMSUNG ELECTRONICS Co., Ltd.
MAY 2 9 2014
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted accordance with requirements of 21 CFR 807.92
-
- Date: 2014. Feb. 06
-
- Submitter
- Company Name: SAMSUNG ELECTRONICS Co., Ltd. A.
- B. Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-742, Republic of Korea
Primary Contact Person 3.
- Name: Donald D. Fickett A.
- Title: Vice President Regulatory & Quality Assurance B.
- Phone Number: 978-564-8523 ﻥ
- FAX Number: 978-750-6677 D.
- E-Mail: dfickett@samsungneurologica.com E.
Secondary Contact Person 4.
- Name: Ha, Aeyoung A.
- B. Title: Regulatory Affairs Manager
- C. Phone Number: +82-31-200-1537
- FAX Number: +82-31-200-1199 D.
- E-Mail: ay.ha@samsung.com E.
Device 5.
- Trade Name: XGEO GF50 A.
- B. Common Name: Digital Diagnostic X-ray System
- Classification Name: System, X-Ray, Stationary ்.
- D. Product Code: KPR
હ. Predicate Device
- Manufacturer: SAMSUNG ELECTRONICS Co., Ltd. A.
- B. Trade Name: XGEO GC80
- C. 510(k) Number: K123098
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510(k) Premarket Notification - Traditional
D. 510(k) Decision Date: 01/08/2013
7. Device Description
This system is 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 device being sent to the XGEO 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 XGEO GF50 is intended to be used for capturing digital X-ray images of various parts of the body including the head, chest, spine, abdomen, joints, hands, feet and other organs.
Intended Use 8.
The XGEO GF50 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.
9. Summary of Technological characteristic of the proposed device compared with the predicate device
The XGEO GF50 does not have significant change in materials, energy source or technological characteristics compared to the predicate device. Comparisons of the following technological characteristics were assessed and the results demonstrate the substantial equivalence to the predicates.
| Specification | Predicate Device | Proposed Device | Discussion |
|---|---|---|---|
| Device Name | XGEO GC80 | XGEO GF50 | |
| Manufacturer | SAMSUNG ELECTRONICS | SAMSUNG ELECTRONICS | |
| 510(k) Number | K123098 | N/A | |
| Appearances | Image: Predicate Device Appearance | Image: Proposed Device Appearance | Equivalent(1) |
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510(k) Premarket Notification - Traditional
| Intended Use | 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. | The XGEO GF50 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. | Same |
|---|---|---|---|
| Configuration | Ceiling type | Floor-mounted or Floor-ceiling type | Equivalent (1) |
| Manufacturer Contents | XGEO GC80 | XGEO GF50 | Discussion | |
|---|---|---|---|---|
| (1)High Voltage Generator | ||||
| Type | High Frequency | High Frequency | Same | |
| Max. Power | 80kW | 52kW | ||
| Tube Voltage | 40-150kV | 40-150kV | Equivalent | |
| OutputRANGE | Tube Current | 10-1000mA | 10-640mA | (2) |
| Exposure Time | 1msec-2sec | 1msec-10sec | ||
| AEC(Automatic Exposure Control) | Yes | Yes | Same | |
| APR (AnatomicallyProgrammed Radiography) | Yes | Yes | Same | |
| (2)Ceiling Suspension | ||||
| MovingRange(mm) | Longitudinal | 1350 ~ 3350(Varies with room size) | 2100(Floor-mounted)2500(Floor ceiling) | Equivalent(3) |
| Lateral | 770 - 2770(Varies with room size) | 220 | ||
| Vertical | 1800 | 1330 | ||
| Vertical TubeMoving method | Motorized/Manual | Manual | Equivalent | |
| Tube AssemblyRotation | -157 ~ +183 | $\pm$ 135 | Equivalent(4) | |
| Brake lockingMethod | Electromagnetic | Electromagnetic | Same | |
| Moving Rail Type | Al Extrusion | Steel plate | Equivalent(5) | |
| Image Preview | O | O | ||
| Display Type | Color LCD | Color LCD | Same | |
| Control Switch Type | Button+ Touch Screen | Button+ Touch Screen | Same |
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510(k) Premarket Notification - Traditional
| Manufacturer Contents | XGEO GC80 | XGEO GF50 | Discussion | |||
|---|---|---|---|---|---|---|
| (3) Wall Stand | ||||||
| VerticalMovement | Mechanism | Motorized/Manual | Manual | Equivalent | ||
| Range(mm) | 400~1,800 | 420~1770 | Equivalent | |||
| Detector | Mechanism | Motorized | NIA | Equivalent(6) | ||
| Tilting | Range | -20-+90 | ||||
| AEC | Conventional | Conventional | Same | |||
| Lines/cm | 84.6 | 84.6 | Same | |||
| Grid | Grid mechanism | Stationary | Stationary | Same | ||
| Removability | Removable | Removable | Same | |||
| Detector Support Mounting | Floor | Floor | Same | |||
| Patient Support Device | Patient handgrips,lateral support bar | Patient handgrips,lateral support bar | Same | |||
| (4)Patient Table | ||||||
| Size(mm) | 2433 X 806 | 2200 X 750(4way)2200 X 810(6way) | Equivalent | |||
| Table Top | Range | Lateral | ±140 | +125 | (7) | |
| (mm) | Longitudinal | ±480 | +500 | |||
| Table height | Mechanism | DC Motor,Ball screw | DC Motor (6way) | Equivalent | ||
| Range(mm) | 545 - 900 | 565 ~ 850 | Equivalent | |||
| Horizontal range of detector(mm) | 590 | 590 | Same | |||
| AEC | Conventional | Conventional | Same | |||
| Lines/cm | 84.6 | 84.6 | Same | |||
| Grid | Grid mechanism | Stationary | Stationary | Same | ||
| Removability | Removable | Removable | Same | |||
| Vertical Sync. | 0 | 0 | Same | |||
| Control Switch Type | Foot switch | Foot switch | Same | |||
| Maximum Patient Weight(kg) | 350(Static, Center load) | 250(Static, Center load) | Equivalent | |||
| (5)Collimator | ||||||
| Overall Size(mm) | H212 X W300X D179 | H185 X W213X D180 | Equivalent | |||
| Beam Limiting BladeMoving Method | Motorized/Manual | Manual | Equivalent | |||
| Manual Operation Method | Volume | Volume | Same | |||
| Collimator Rotation | +45 | 400 | Equivalent |
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510(k) Premarket Notification - Traditional
| Manufacturer Contents | XGEO GC80 | XGEO GF50 | Discussion | |
|---|---|---|---|---|
| (8) | ||||
| Beam Light Source | LED | Halogen Lamp | Equivalent(9) | |
| Light Field Indicator Timer | O | O | Same | |
| Side Lamp | O | O | Same | |
| Laser Module | Laser Module | Same | ||
| Field Size / SID Display | Color LCD | Color LCD | Same |
| Manufacturer Contents | XGEO GC80 | XGEO GF50 | Discussion | |
|---|---|---|---|---|
| (6) Detector | ||||
| Name | SDX-4336CP | SDX-4343CS | S4335-W | |
| CsI | CsI | Same | ||
| Detector Type | Indirect | Indirect | Indirect | Same |
| Detector Area | 14"X17"(351mmX423mm) | 17"X17"(429mmX429mm) | 14"X17"(345mmX425mm) | Equivalent |
| Number of pixels | 2340X2820 | 3000X3000 | 2466X3040 | |
| Pixel Pitch(um) | 150 | 143 | 140 | Equivalent |
| High Contrast LimitingResolution (LP/mm) | 3.3 | 3.5 | 3.5 | (10) |
| Communication | Wired | Wired / Wireless | Equivalent(11) |
| No. | Description | Explanation |
|---|---|---|
| (1) | Configuration | Predicate device is a ceiling type digital x-ray imaging system andthe proposed device is a Floor-mounted or Floor ceiling typedigital x-ray imaging system. The difference of THU locationdoesn't affect the fundamental scientific characteristic of x-rayoperation. |
| (2) | High Voltage Generator | The proposed device has the lower output power and tube currentspecification than the predicate device. The wider time range ofproposed device makes the equivalent mAs range to predicatedevice. |
| (3) | Moving range | Due to the nature of Floor-mounted device, it has less flexibility ofmoving range than ceiling type device. This is a matter ofconvenience to use. Therefore proposed device is equivalent topredicate device. |
| (4) | Tube Assembly Rotation | Predicate device has wider range of the tube assembly rotationthan proposed device. The rotation range of proposed device, ±135, can operate the most of procedure intended for use ingeneral radiography which makes equivalence of the proposeddevice to predicate device. |
| (5) | Moving Rail Type | The moving rail type of predicate and proposed device is designed suitable for each type of device, ceiling and floor mounted type. As the XGEO GF50 is complied with IEC60601-1, the fundamental mechanical safety is equivalent to the predicate device. |
| (6) | Detector Tilt | Proposed device doesn't provide detector tilt function. As detector tilt function is an optional function and not an essential requirement for safety and effectiveness of the system, it doesn't affect to the safety and effectiveness. |
| (7) | Table size and moving range | Proposed device has 2 types of the patient tables provides option to physicians for their convenience. The patient tables are complied with IEC60601-1 for basic electrical and mechanical safety. Therefore, it is equivalent to the predicate device. |
| (8) | Collimator Rotation | Proposed device has more collimator rotation angle than predicate device which gives more flexibility to the collimator positioning for patient. |
| (9) | Beam light source | Predicate device used LED lamp and proposed device uses Halogen lamp for beam light source. Halogen lamp is the one generally used light source before LED lamp was used. It is equivalent to the predicate device. |
| (10) | Resolution of detector | Proposed detector has better resolution than predicated. In the specification sheet, to compare with the same size detector (SDX-4336CP), proposed detector shows more number of pixels, short pixel pitch and higher contrast limiting resolution.In non-clinical data, the propose detector shows better curves and measurements of MTF and DQE than predicate device.In clinical data, the radiologists evaluate the image of XGEO GF50 is substantially equivalent to predicate device. |
| (11) | Communication | Proposed device supports wireless connection and wired connection by tether, while PD only supports wired connection.To ensure the safety and effectiveness of wireless communication between detector and workstation, the wireless function is tested by EN 301 489-1, EN 301 489-17, 47 CFR Part 15C, 47 CFR Part 15E, wireless specification and performance in testing lab and actual environment and evaluated under the risk management followed by a guidance, Radio frequency Wireless Technology in Medical Devices |
:
・
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510(k) Premarket Notification - Traditional
10. Safety, EMC and Performance Data:
Electrical, mechanical, environmental safety and performance testing according to standard ES 60601-1(2012), 21CFR1020.30 and 21CFR1020.31 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2(2007). Wireless function was tested and verified followed by guidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfied.
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K140322
Page 7 of
510(k) Premarket Notification - Traditional
11. Non-clinical data
Non clinical test was conducted for imaging performance of the proposed detector. Both of the predicate device and proposed device are based on a-Si TFT photodiode arrays with a scintillator designed for general radiography. MTF and DQE were tested and measured by IEC 62220-1. MTF curves and measurements from the two detectors were compared and it shows that the propose detector perform better than the predicate in terms of the resolution at all spatial frequencies tested. In DQE, the propose device also has better DQE performance at all spatial frequencies tested because scintillator deposition method is different. Therefore, in non-clinical data review, the XGEO GF50 is substantially equivalent with the predicate device.
12. Clinical data
According to the CDRH guidance for the submission of 510(k)'s for Solid State X-ray Imaging Devices, concurrence study was conducted. The evaluation of the qualified radiologists in the study shows that XGEO GF50 provides images of equivalent diagnostic capability to the predicate device. It demonstrates that XGEO GF50 is substantially equivalent with the predicate device.
13. 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 GF50 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 29, 2014
SAMSUNG ELECTRONICS Co., Ltd. % Jeongpyo Hong Assistant Manager, Regulatory Affairs 129, Samsung-ro, Yeongtong-gu Suwon-si. Gyeonggi-do. 443-742 REPUBLIC OF KOREA
Re: K140326
Trade/Device Name: XGEO GF50 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: April 28, 2014 Received: April 29, 2014
Dear Jeongpyo Hong:
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-Jeongpyo Hong
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sm.7)
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):
Device Name: XGEO GF50
Indications for Use:
The XGEO GF50 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.
× Prescription Use (Part 21 CFR 801 Subpart D)
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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)
§ 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.