The Optima XR646 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and is intended for use in all routine radiography exams.

The device is not intended for mammographic applications.

Device Description

The Optima XR646 remains a radiographic X-ray system capable of generating radiographic images of human anatomy.

The Optima XR646 is designed to handle radiographic applications using GE's flat-panel wireless digital detector. The digital detector is comprised of amorphous silicon and cesium iodide scintillator. The resulting digital image can be sent through a DICOM network for applications such as printing, viewing and storage.

The Optima XR646 Digital Radiographic Imaging system consists of a WallStand, elevating table, overhead Tube support, X-ray tube, collimator, system controller, X-ray generator, and wireless or tethered digital detector. Various configurations such as Table only, WallStand only, or OTS only are available to meet customer radiographic requirements.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the GE Optima XR646, a digital radiographic X-ray system. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone study for a new AI-powered diagnostic device.

Therefore, the document does not contain the information required to answer your request fully. Specifically:

No acceptance criteria for an AI device are mentioned. The document discusses regulatory compliance for an X-ray system.
No study proving an AI device meets acceptance criteria. The document states that clinical studies were not required to support substantial equivalence for this X-ray system, and changes were verified and validated through bench testing.
No information on sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details for an AI algorithm. These are all concepts related to the evaluation of AI/ML-driven diagnostic devices, which is not the subject of this 510(k) submission.

The 510(k) submission details the device description, intended use, indications for use, and a comparison to predicate devices, focusing on the system's hardware and basic radiographic image generation capabilities. It highlights that the changes precipitating this 510(k) were related to hardware modifications and software control for the Image Pasting feature, and that these changes were validated through bench testing to ensure they did not introduce new safety or effectiveness issues.

In summary, this document is about the regulatory clearance of an X-ray imaging system, not an AI-powered diagnostic tool, and thus does not include the specific details you requested regarding AI acceptance criteria and studies.

Summary

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

January 26, 2016

GE Hualun Medical Systems Co., Ltd. Kennv Ma Regulatory Affairs Manager - X ray No.1, Yong Chang North Road Economic & Technology Development Zone Beijing, 100176 CHINA

Re: K143270

Trade/Device Name: Optima XR646 Regulation Number: 21 CFR 892.1680 Regulation Name: Station X-ray System Regulatory Class: Class II Product Code: KPR, MQB Dated (February 3, 2015): Received (February 5, 2015):

Dear Kenny Ma:

This letter corrects our substantially equivalent letter of February 3, 2015.

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

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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.

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,

Astest Oclo

Robert Ochs, Ph.D. 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) K143270

Device Name Optima XR646

Indications for Use (Describe)

The device is not intended for mammographic applications.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle has a white border and a few white swirls around the edge, giving it a dynamic and recognizable appearance.

510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	October 29, 2014
Submitter:	GE Healthcare, (GE HUALUN MEDICAL SYSTEMS CO. Ltd)
	No.1 Yong Chang North Road, Beijing EconomicTechnological Development Zone BEIJING 100176 CHINA
Primary Contact Person:	Kenny Ma
	Regulatory Affairs Manager
	GE Healthcare, (GE HUALUN MEDICAL SYSTEMS CO. Ltd)
	Office: +8610 59347159eFax: +8610 67882574Email: Kenny.Ma@ge.com
Secondary ContactPerson:	Christopher Paulik
	RA Leader - Product
	GE Healthcare, (GE Medical Systems, LLC)
	+1 262 548 2010Email: Christopher.A.Paulik@ge.com
Device Trade Name:	Optima XR646
Common/Usual Name:	Digital Radiographic X-Ray System
Classification Names:Product Code:	Stationary X-Ray System (21CFR § 892.1680), solid state x-ray imager (21CFR § 892.1680)KPR, MQB
Predicate Device(s):	Stationary X-Ray System, MODEL: Discovery XR656(K132261) and Revolution XR/d with Image Pasting(K050704)
Device Description:	The Optima XR646 remains a radiographic X-ray systemcapable of generating radiographic images of humananatomy.
	The Optima XR646 is designed to handle radiographicapplications using GE's flat-panel wireless digital detector.The digital detector is comprised of amorphous silicon andcesium iodide scintillator. The resulting digital image canbe sent through a DICOM network for applications such as
printing, viewing and storage.
The Optima XR646 Digital Radiographic Imaging systemconsists of a WallStand, elevating table, overhead Tubesupport, X-ray tube, collimator, system controller, X-raygenerator, and wireless or tethered digital detector.Various configurations such as Table only, WallStand only,or OTS only are available to meet customer radiographicrequirements.
Intended Use:	General Purpose Digital Radiographic Imaging System
Indication for Use:	The Optima XR646 is intended to generate digitalradiographic images of the skull, spinal column, chest,abdomen, extremities, and other body parts in patients ofall ages. Applications can be performed with the patientsitting, standing, or lying in the prone or supine positionand is intended for use in all routine radiography exams.
	The device is not intended for mammographicapplications.
Technology:	The Optima XR646 employs the same fundamentalscientific technology as its predicate device.
Determination ofSubstantial Equivalence:	Summary of Non-Clinical Tests:The Optima XR646 is based on the software and Hardwareplatform of the predicate device. It was designed and ismanufactured under GE's quality system that meets theQuality System Regulations of 21 CFR 820 and ISO 13485.Optima XR646 is certified to comply with the X-rayrequirements of 21 CFR Subchapter J - RadiologicalHealth, as well as safety requirements of IEC 60601-1 andassociated collateral and particular standards.The Optima XR646 and its applications comply withvoluntary standards. The following quality assurancemeasures were applied to the development of the system:■ Risk Analysis■ Requirements Reviews■ Design Reviews■ Testing on unit level (Module verification)■ Integration testing (System verification)■ Performance testing (Verification)
Safety testing (Verification) Simulated use testing (Validation)
Minor obsolescence and feature changes have occurred in the evolution of the device for which a 510(k) was not required based on evaluation using the FDA "Deciding When to Submit a 510(k) for a change to an Existing Device". These include changes in operator display and the reduction of option in overhead rails. The changes that precipitated this 510(k) submission were the reduction in auto positioning axes of the Overhead Tube Support that resulted in a change in the sequence of acquisitions for the Image Pasting feature.
The Image Pasting feature change does not affect the functional equivalence of the product today. These differences do not raise new issues of safety and effectiveness. The Overhead Tube Support hardware change and the Overhead Tube Support movement control software change for Image Pasting function were verified and validated through bench testing. All the design inputs requirements were successfully tested for Optima XR646 with Image Pasting and meet the design specifications and user requirements. This Verification and Validation bench testing demonstrated that no adverse effects have been introduced by the changes. The control mechanism, operating principle, energy type and Intended use have not changed. The indication for use is slightly modified to reflect the removal of the VolumeRad feature from this version of the product also due to the reduction of auto positioning axes on the Overhead Tube Support.
Based on the successful verification, validation, and bench testing and the above comparison, GE Healthcare believes that the Optima XR646 is as safe and effective and performs in a substantially equivalent manner to the predicate device.
Summary of Clinical Tests: The subject of this premarket submission, Optima XR646, did not require clinical studies to support substantial equivalence. All changes were verified and validated during bench testing and did not reveal any new questions of safety and effectiveness.
Conclusion:	GE Healthcare considers the Optima XR646 to be as safeand effective, and performance is substantially equivalentto the predicate device.

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510(k) Premarket Notification Submission

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Image /page/5/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. There are three white, flame-like shapes surrounding the circle, giving the impression of movement or energy.

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Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. There are three wave-like shapes emanating from the circle, positioned at the top, bottom, and right side of the circle. The logo is simple and recognizable, representing the multinational conglomerate corporation.

510(k) Premarket Notification Submission

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.