The OEC Elite™ MiniView™ (mobile mini C-Arm) is designed to provide physicians with real time general fluoroscopic visualization of patients of all ages. It is intended to aid physicians and surgeons during diagnostic or therapeutic treatment/surgical procedures of the limbs/extremities and shoulders including, but not limited to, orthopedics and emergency medicine.

Device Description

The OEC Elite™ MiniView™ is a mobile fluoroscopic mini C-arm system that provides fluoroscopic images of patients of all ages during diagnostic, treatment, and surgical procedures of the shoulders, limbs, and extremities. The system consists of a C-arm attached to an image processing workstation. A CsI(TI) -CMOS flat panel detector and the identical X-ray source monoblock are used for image acquisition.

The C-arm supports the high-voltage generator, X-ray tube, X-ray controls, collimator, and the FPD. The C-arm is capable of performing linear (vertical, horizontal, orbital) and rotational motions that allow the user to position the X-Ray imaging components at various angles and distances with respect to the patient extremity anatomy to be imaged. The C and support arm are mechanically balanced allowing for ease of movement and capable of being "locked" in place using an electronically controlled braking system. The workstation is a stable mobile platform that supports the C-arm, image display monitor(s), image processing equipment/software, recording devices, data input/output devices and power control systems.

The primary technology change for the subject device compared to the unmodified predicate OEC Elite MiniView, was to add an optional wireless footswitch which provides identical functionalities as the wired footswitch to control X-ray on and off.

AI/ML Overview

This document describes the 510(k) summary for the GE OEC Elite™ MiniView™ device, which is a mobile fluoroscopic mini C-arm system. The specific change being submitted for review is the addition of an optional wireless footswitch.

Here's an analysis of the provided text to answer your questions regarding acceptance criteria and the study proving the device meets them:

Crucially, this 510(k) submission states that no clinical studies were required to support substantial equivalence due to the nature of the modification (adding a wireless footswitch). Therefore, many of your questions related to clinical study design (sample size, expert ground truth, MRMC studies, standalone performance) will not be applicable or directly answerable from this document.

The primary method of demonstrating device performance and safety for this submission was through non-clinical testing, including design verification and validation, risk management activities, and compliance with recognized standards.

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

Since this is a submission for a modification (wireless footswitch) and relies on non-clinical testing for substantial equivalence, the "acceptance criteria" are primarily related to product safety, effectiveness, and functional equivalence to the wired footswitch and predicate device.

Acceptance Criteria (Inferred)	Reported Device Performance (Summary from Document)
Functional Equivalence: The wireless footswitch provides identical functionalities to the wired footswitch for controlling X-ray on/off.	The wireless footswitch provides "identical functionalities as the wired footswitch to control X-ray on and off." The "functionalities are identical."
Safety: Device operates safely in conjunction with the wireless footswitch.	Developed under GE Healthcare's design controls and quality management system. Risk management activities identified, reviewed, and mitigated potential issues. Mitigations verified and validated.
Effectiveness: The addition of the wireless footswitch does not negatively affect the overall safety and effectiveness of the device.	Design verification and validation testing performed confirmed that "the safety and effectiveness of the devices has not been affected."
Electromagnetic Compatibility (EMC) & Coexistence: The wireless footswitch operates without causing or being susceptible to electromagnetic interference.	EMC and coexistence testing performed per the FDA "Radio Frequency Wireless Technology in Medical Devices" Guidance (August 14, 2013). Results acceptable.
Compliance with Standards: Device meets applicable electrical, safety, and performance standards.	Tested by an NRTL and certified compliant with IEC 60601-1 Ed. 3 series, including IEC60601-2-54 and IEC 60601-2-43. All applicable 21CFR Subchapter J performance standards are met.
No New Questions of Safety/Effectiveness: The modification should not introduce new safety or effectiveness concerns.	"The addition of the optional wireless footswitch to the system does not raise new questions on safety and effectiveness."

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

Sample Size for Test Set: Not applicable in the context of clinical data. The "test set" here refers to the device itself and its components undergoing engineering and functional verification/validation testing. This is not a patient-based test set.
Data Provenance: The testing was conducted internally by GE Hualun Medical Systems Co. Ltd. in Beijing, China, as part of their design control processes. This is prospective engineering and quality assurance testing, not data collected from patients.

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)

Not applicable. Ground truth in a clinical sense (e.g., disease presence) was not established. The "ground truth" for this engineering submission is functional correctness and safety established by engineering specifications, international standards, and internal quality processes.

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

Not applicable. This was not a human reader adjudication study. The "adjudication" was based on successful completion of predetermined engineering tests and compliance with regulatory standards, as overseen by GE's quality management system.

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

No MRMC study was done. The document explicitly states: "The subject of this premarket submission, OEC Elite MiniView with the addition of the wireless footswitch, did not require clinical studies to support substantial equivalence." This device is not an AI-assisted diagnostic tool.

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

Not applicable. This device is a medical imaging system, and the submission is for a hardware control component (wireless footswitch), not a standalone algorithm or AI.

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

The "ground truth" used for this submission is based on engineering specifications, functional requirements, and compliance with recognized industry and electrical safety standards. For example, the footswitch must reliably transmit an "X-ray ON/OFF" signal, and the device must maintain its safety characteristics as per IEC 60601 series standards. This is not a clinical ground truth.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, so there is no "training set."

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

Not applicable. As there is no training set for an AI model, there is no ground truth established for one.

Summary

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

July 12, 2017

GE HUALUN MEDICAL SYSTEMS CO. LTD. % Ms. Lifeng Wang Regulatory Affairs Leader No1 Yong Chang North Road Beijing Economic Technological Development Zone Beijing 100176 Beijing CHINA

Re: K171800

Trade/Device Name: OEC Elite™ MiniView™ Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OXO, JAA Dated: June 15, 2017 Received: June 16, 2017

Dear Ms. Wang:

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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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/Resourcesfor You/Industry/default.htm. 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 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.

Michael D. O'Hara For

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)

K171800

Device Name OEC Elite™ MiniView™

Indications for Use (Describe)

The OEC Elite MiniView (mobile mini C-Arm) is designed to provide physicians with real time general fluoroscopic visualization of patients of all ages. It is intended to aid physicians and surgeons during diagnostic or therapeutic treatment/surgical procedures of the limbs/extremities and shoulders including, but not limited to, orthopedics and emergency medicine.

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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GE Healthcare

510(k) Premarket Notification Submission- OEC Elite™ MiniView™

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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

Date:Submitter:	June 16, 2017GE HUALUN MEDICAL SYSTEMS CO. Ltd.No.1 Yong Chang North Road, Beijing EconomicTechnological Development ZoneBeijing 100176,China
Manufacturer/Manufacturing Location	GE HUALUN MEDICAL SYSTEMS CO. Ltd.No.1 Yong Chang North Road, Beijing EconomicTechnological Development ZoneBeijing 100176,China
Primary Contact Person:	Lifeng WangRegulatory Affairs ManagerGE Healthcare+86 10 57083145Lifeng.Wang@ge.com
Secondary Contact Person:	Helen PengRegulatory Affairs DirectorGE Healthcare+1 262 424-8222Hong.Peng@ge.com
Device Trade Name:	OEC Elite™ MiniView™
Common/Usual Name:	Fluoroscopic X-Ray System, MobileMini Mobile C-Arm, Mini C-Arm
Classification Names:	Image-intensified fluoroscopic x-ray system
Device Class	Class II
Classification regulation:	21CFR 892.1650
Primary Product Code:	OXO
Secondary Product Code:	JAA
Predicate Device(s):	K160131, OEC Elite MiniView
Device Description:	The OEC Elite™ MiniView™ is a mobile fluoroscopic mini C-arm system that provides fluoroscopic images of patients of allages during diagnostic, treatment, and surgical procedures of theshoulders, limbs, and extremities. The system consists of a C-armattached to an image processing workstation. A CsI(TI) -CMOSflat panel detector and the identical X-ray source monoblock areused for image acquisition.
	The C-arm supports the high-voltage generator, X-ray tube, X-raycontrols, collimator, and the FPD. The C-arm is capable ofperforming linear (vertical, horizontal, orbital) and rotationalmotions that allow the user to position the X-Ray imagingcomponents at various angles and distances with respect to thepatient extremity anatomy to be imaged. The C and support armare mechanically balanced allowing for ease of movement andcapable of being "locked" in place using an electronicallycontrolled braking system. The workstation is a stable mobileplatform that supports the C-arm, image display monitor(s),image processing equipment/software, recording devices, datainput/output devices and power control systems.
	The primary technology change for the subject device comparedto the unmodified predicate OEC Elite MiniView, was to add anoptional wireless footswitch which provides identicalfunctionalities as the wired footswitch to control X-ray on andoff.
Intended Use:	The OEC Elite™ MiniView™ (mobile mini C-arm) is intended toprovide fluoroscopic images of the patient during diagnostic ortherapeutic treatment/surgical procedures of the limbs/extremitiesand shoulders.
Indications for Use	The OEC Elite™ MiniView™ (mobile mini C-Arm) is designedto provide physicians with real time general fluoroscopicvisualization of patients of all ages. It is intended to aidphysicians and surgeons during diagnostic or therapeutictreatment/surgical procedures of the limbs/extremities andshoulders including, but not limited to, orthopedics andemergency medicine.
Technology:	The modified OEC Elite™ MiniView™ employs the samefundamental scientific technology as the unmodified predicatedevice. The proposed device will provide an optional off-the-shelfwireless foot switch uses 2.4GHz radio frequency technologywith proprietary private protocols. The introduction of thiswireless footswitch does not change any existing hardware orsoftware of the predicated device. The new option is equivalent tothe wired footswitch on the predicate in that the functionalitiesare identical. The wireless option provides placement flexibilityand reduces cable clutter.
Determination ofSubstantial Equivalence:	Summary of Non-Clinical Testing:
	The modified OEC Elite™ MiniView™ system with the wirelessfootswitch was developed under the GE Healthcare's designcontrols processes and overall quality management system.
	The system has been tested by an NRTL and certified compliantwith the IEC 60601-1 Ed. 3 series, including IEC60601-2-54 andIEC 60601-2-43. All applicable 21CFR Subchapter Jperformance standards are met.
	Risk management activities including using risk analysis toidentify any potential issues incorporating the wireless footswitchwere performed. These issues were reviewed and mitigated withinherent safe designs and labeling. The mitigations were verifiedand validated as a part of the design verification and validationtesting that has been executed with acceptable results. Thistesting also includes the EMC and coexistence testing per the"Radio Frequency Wireless Technology in Medical Devices"Guidance for Industry and Food and Drug Administration Staffissued on August 14, 2013 (Wireless Guidance).
	Clinical Testing:The subject of this premarket submission, OEC Elite MiniViewwith the addition of the wireless footswitch, did not requireclinical studies to support substantial equivalence.
	Design verification and validation testing was performed toconfirm that the safety and effectiveness of the devices has notbeen affected. The test plans and results have been executed withacceptable results.
Conclusion:	The OEC Elite MiniView incorporates a wireless footswitch forthe user to initiate and terminate x-ray exposures as an option.The addition of the optional wireless footswitch to the systemdoes not raise new questions on safety and effectiveness. Themodified subject device has the same technological characteristicsand perform as well as the unmodified predicate device and othersimilar devices that incorporate a wireless footswitch currently onthe market.
	Based on the successful verification and validation testing,additional engineering bench testing per the FDA Wirelessguidance, conformance to standards, and development under GE'sQuality Management System, we believe that the modified OECMiniView is of comparable type and substantially equivalent tothe predicate device OEC Elite MiniView (K160131), andtherefore is safe and effective for its intended use.

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GE Healthcare

510(k) Premarket Notification Submission- OEC Elite™ MiniView™

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GE Healthcare

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510(k) Premarket Notification Submission- OEC Elite™ MiniView™

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.