The WV1417A Digital X-ray Direct Imaging Flat Panel Detector System provides a digital image capture capability for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The device has application wherever conventional screen-film systems are currently used.

Device Description

The WV1417A Digital X-ray Direct Imaging Flat Panel Detector System is used to directly capture and convert conventional projection X-ray images to digital images. A image preview function can be displayed on a review monitor for viewing. The diagnostic image can be transmitted through LAN for diagnostic viewing and printing. The device provides digital image capture for conventional radiographic examinations, excluding fluoroscopic, angiographic and mammography applications. The system differs from traditional X-ray systems in that instead of exposing a film for subsequent wet chemical processing to create a hardcopy image, a device called a detector array is used to capture the image in electronic form. The digital data are then used to produce hardcopy and softcopy images. The WV1417A Digital X-ray Direct Imaging Flat Panel Detector System (Fig.VI-1) is composed of the following: A detector array is used to capture the diagnostic image. An array controller is used to control detector array, harmonize the working between the array controller and high-voltage generator for exposal synchronization and image transmission. A system controller is used to enter patient demographic information, initiate the exposure process, review captured images, and accept or reject captured images. The system controller is also used to send images to a hardcopy printer, workstation, or archive, and manage images temporarily stored in its database. Here, the system controller is the software device and which should install in the PC hardware system purchased by themselves of customer. The system controller also can make some disposal for the original image, such as gain, offset and defective pixel correction. By capturing, previewing, and storing and image, the system enables an operator to check the quality of an image at the time of exposure without having to develop a film.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets said criteria. It primarily focuses on the device's administrative and descriptive information for its 510(k) submission.

However, based on the limited information provided, here's what can be extracted and inferred:

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

The document states, "All the information about the device performance has provided. The Clinical Test Report has provided." This indicates that performance data was submitted, but the specific acceptance criteria and the detailed performance results are not included in the provided text. We only know that electrical safety and electromagnetic compatibility tests were conducted and the device was found substantially equivalent to a predicate device.

Acceptance Criteria	Reported Device Performance
Electrical Safety (IEC 60601-1)	Compliant (as implied by regulatory clearance)
Electromagnetic Compatibility (IEC 60601-1-2)	Compliant (as implied by regulatory clearance)
Substantial Equivalence to Predicate Device	Achieved (as stated in the 510(k) summary)
Image Capture Capability for Conventional Radiographic Examinations (excluding fluoroscopic, angiographic, and mammographic applications)	Demonstrated (as per intended use and regulatory clearance, though specific metrics are not detailed)

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

The document mentions "The Clinical Test Report has provided." However, there is no information regarding:

The sample size used for the test set.
The country of origin of the data.
Whether the data was retrospective or prospective.

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)

The provided text does not contain any information about the number of experts, their qualifications, or how ground truth was established for a test set. This detail would typically be found within the clinical test report, which is not included here.

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

The provided text does not contain any information about the adjudication method used for the 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

The provided text does not indicate that an MRMC comparative effectiveness study was done. The device description suggests it's a direct imaging system, not an AI-assisted diagnostic tool, thus this type of study would likely not be relevant to its intended use as described.

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

The device is a "Digital X-ray Direct Imaging Flat Panel Detector System," which captures and converts X-ray images. It's an imaging hardware system, not an algorithm that performs standalone analysis. Therefore, a standalone performance study of an algorithm is not applicable in this context. The focus is on the quality of the captured digital image compared to traditional film.

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

The provided text does not specify the type of ground truth used in any clinical testing. Given its function as an imaging detector, ground truth would likely involve image quality metrics compared against a predicate device or established standards for conventional radiography, potentially assessed by expert radiologists, but this is not explicitly stated.

8. The sample size for the training set

Given that this is a hardware device for digital image capture and not an AI/machine learning algorithm, the concept of a "training set" in the traditional sense is not applicable.

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

As described in point 8, the concept of a "training set" is not applicable for this device.

Summary

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K090062
Page 1 of 3

Chapter III 510(k) Summary

MAY 18 2009

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92.

The Assigned 510(k) Number is:

1. Device Information

Device Common Name: Solid State X-Ray Imaging Devices Device Trade/Proprietary Name: WV1417A Digital X-ray Direct Imaging Flat Panel Detector System

Classification Information: (1) Classification Name: Solid State X-Ray Imaging Devices (2) Regulation Number:892.1650 (3)Product Code: MBQ (4) Class: Il (5) Review Panel: Radiology

2. Submitter Information

Manufacturer:

Direct Digital Imaging Technology (Beijing) Inc. #33 Building, Yuquan Wisdom Vale. Tsinghua Science Park, #3 Min Zhuang Road Haidian District, Beijing 100097, CHINA

Contact Person of the Submission

Ms. Diana Hong Mr. Tarzan Wang Suite 8D, Zhongxin Zhongshan Mansion, No.19, Lane 999, Zhong Shan Nan Er Road Shanghai, China 20020 Phone: +86-21-64264467 Fax: (240) 238-7587 Email: Diana.hong@mid-link.net

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K090062
Page 2 of 3

3. Device Description

The WV1417A Digital X-ray Direct Imaging Flat Panel Detector System (Fig.VI-1) is composed of the following:

A detector array is used to capture the diagnostic image.

An array controller is used to control detector array, harmonize the working between the array controller and high-voltage generator for exposal synchronization and image transmission.

A system controller is used to enter patient demographic information, initiate the exposure process, review captured images, and accept or reject captured images. The system controller is also used to send images to a hardcopy printer, workstation, or archive, and manage images temporarily stored in its database. Here, the system controller is the software device and which should install in the PC hardware system purchased by themselves of customer.

The system controller also can make some disposal for the original image, such as gain, offset and defective pixel correction.

By capturing, previewing, and storing and image, the system enables an operator to check the quality of an image at the time of exposure without having to develop a film.

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KC9CCA2
Page 3 of 3

4. Intended Use

5. Substantially Equivalence Determination

The applicant devices Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the applicant devices are determined as safe and effectiveness.

6. Test Summary

The device is electrically operated and the electrical safety and electromagnetic compatibility following IEC 60601-1 and IEC60601-1-2 were conducted.

All the information about the device performance has provided.

The Clinical Test Report has provided.

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Image /page/3/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a stylized eagle in blue on the left side of the image. To the right of the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue. The text is in all caps and is aligned to the left.

Public Health Service

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

Direct Digital Imaging Technology (Beijing), Inc. % Ms. Diana Hong General Manager Shanghi Mid-Link Business Consulting Co., Ltd. Suite 8D, No. 19, Lane 999, Zhongshan No. 2 Road (s) SHANGHAI 200030 CHINA

AUG 2 3 2013

Re: K090062

Trade/Device Name: WV1417A Digital Direct Imaging Flat Panel Detector System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: March 19. 2009 Received: March 23, 2009

Dear Ms. Hong:

This letter corrects our substantially equivalent letter of May 18, 2009.

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 I va may other other general 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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication For Use

510(k) Number (if known): ____ Pending

ing KC90062

Device Name: WV1417A Digital Direct Imaging Flat Panel Detector System

Indications for Use:

Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Huls Remu

Division S (Division of Reproductive, Abdominal and Radiological Devi 510(k) Number

Page_1 of

l .

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.