The OEC Elite mobile fluoroscopy system is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, vasular, cardiac, critical care, and emergency procedures.

Device Description

The OEC Elite is a Mobile Fluoroscopic C-arm Imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic X-Ray images during diagnostic, interventional, and surgical procedures. These images help the physician visualize the patient's anatomy and interventional tools. This visualization helps to localize clinical regions of interest and pathology. The images provide real-time visualization and records of pre-procedure anatomy, in vivo-clinical activity and post-procedure outcomes. The system is composed of two primary physical components. The first is referred to as the "C - Arm" because of its "C" shaped image gantry; the second is referred to as the "Workstation", which is the primary interface for the user to interact with the system.

The C-arm is a stable mobile platform capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral, wig-wag) that allow the user to position the X-Ray image chain at various and distances with respect to the patient anatomy to be imaged. The C - arm is mechanically balanced allowing for ease of movement and capable of being "locked" in place using a manually activated lock. The C-Arm is comprised of the high voltage generator, software, X-ray control, and a "C" shaped image gantry, which supports an X-ray tube and a Flat Panel Detector or Image Intensifier, depending on the choice of detector configuration desired.

The workstation is a stable mobile platform with an articulating arm supporting a color image, high resolution, LCD display monitor. It also includes image processing equipment/software, recording devices, data input/output devices and power control systems.

The primary purpose of the mobile fluoroscopy system is to provide fluoroscopic images of the patient during diagnostic, interventional, and surgical procedures such as orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, cardiac, critical care and emergency procedures.

AI/ML Overview

This document (K172550) is a 510(k) summary for a medical device (OEC Elite fluoroscopy system) and does not describe a study related to an AI/ML-based device.

Therefore, many of the requested details, such as "number of experts used to establish ground truth", "adjudication method", "MRMC study", "standalone performance", "training set size", and "ground truth for training set", are completely irrelevant to this document.

The document discusses the substantial equivalence of an updated version of a fluoroscopy system (OEC Elite with Cardiac option) to its predicate device. This is a hardware/software update to an imaging device, not an AI/ML diagnostic or assistive tool.

Based on the provided text, here's what can be extracted regarding acceptance criteria and performance, focusing on the device's performance rather than an AI's performance:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating that the updated OEC Elite with Cardiac option maintains the performance of the predicate device and meets established industry standards for X-ray imaging systems. The "reported device performance" are statements of compliance and successful testing rather than specific numerical results for all metrics.

Acceptance Criterion (Compliance/Performance Metric)	Reported Device Performance
General Compliance/Quality
Design Input and User Needs Met	"Verification and validation, including hazard mitigation has been executed with results demonstrating the OEC Elite mobile fluoroscopy system met design input and user needs."
IEC 60601-1 Ed. 3 series compliance (including IEC 60601-2-43)	"The system has been tested and is compliant with the IEC 60601-1 Ed. 3 series, including IEC 60601-2-43."
21CFR Subchapter J performance standards compliance	"All applicable 21CFR Subchapter J performance standards are met."
Developed under GE OEC Medical Systems Quality Management System (design controls, risk management, software development)	"The OEC Elite system was developed under the GE OEC Medical Systems Quality Management System, including design controls, risk management and software development life cycle processes." "The changes described above do not change the control mechanism, operating principle, energy type, or intended use from the predicate device." "The substantial equivalence was also based on software documentation for a 'Moderate' level of concern device."
Compliance with FDA "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices' (SSXI)"	"It was determined the modified system continues to comply to this guidance."
Imaging Performance (Identical to predicate OEC Elite)	"All the image quality/performance testing identified for fluoroscopy found in FDA's 'Information for Industry: X-ray Imaging Devices- Laboratory Image Quality and Dose Assessment. Tests and Standards' was performed with acceptable results." "showing identical performance of the subject device to the predicate device OEC Elite." Specific performance aspects mentioned as being evaluated:
DOE (Dose Object Eye?)	Not specified numerically, but stated to be in compliance.
Dynamic Range	Not specified numerically, but stated to be in compliance.
Spatial Resolution (MTF, Limiting Resolution)	Not specified numerically, but stated to be in compliance.
Temporal Resolution	Not specified numerically, but stated to be in compliance.
Contrast Resolution	Not specified numerically, but stated to be in compliance.
Beam Alignment	Not specified numerically, but stated to be in compliance.
Dose Rate	Not specified numerically, but stated to be in compliance.
Stability of device characteristics over time	Not specified numerically, but stated to be in compliance.
Brightness Uniformity	Not specified numerically, but stated to be in compliance.
Fluoroscopy Frame Rate	Not specified numerically, but stated to be in compliance.
Reuse Rate	Not specified numerically, but stated to be in compliance.
Cardiac Profile Performance (Enhancement)
Reduce blooming artifacts, enhance visibility of moving features and vessels with contrast agent (compared to not using profile)	"The Cardiac profile reduces blooming artifacts and enhances the visibility of moving features and vessels filled with a contrast agent when compared to not using the profile." This is a qualitative statement of improvement, not a quantified measurement with acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states that no clinical images or human studies were used to demonstrate substantial equivalence for the cardiac option. The testing conducted was "engineering (non-Clinical) testing," "engineering bench testing," and "imaging performance evaluation using anthropomorphic phantoms."

Therefore, there is no "test set" in the sense of clinical patient data, nor is there data provenance (country of origin, retrospective/prospective). The "sample size" would refer to the number of phantom tests or bench tests, which are not specified in numerical terms beyond "successful verification and validation testing" and "additional engineering bench testing."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. No ground truth was established by human experts for a clinical dataset because no clinical dataset was used for demonstration of substantial equivalence.

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

Not applicable. No clinical test set requiring adjudication was used.

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

Not applicable. This is not an AI device, and no MRMC study was performed.

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

Not applicable. This is a fluoroscopy imaging system, not an AI algorithm.

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

The "ground truth" for the device's technical performance was established by measurement against established engineering standards and phantom studies, rather than clinical ground truth (e.g., pathology). The "truth" was defined by what parameters an X-ray imaging system should meet.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set" of data. The software changes were built upon an existing architecture and followed a standard software development lifecycle.

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

Not applicable. No training set was used in the context of AI/ML.

Summary

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November 16, 2017

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GE OEC Medical Systems, Inc. % Ms. Rachel Schandel Regulatory Affairs Leader 384 Wright Brothers Drive SALT LAKE CITY UT 84116

Re: K172550

Trade/Device Name: OEC Elite Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA, OXO Dated: October 20, 2017 Received: October 23, 2017

Dear Ms. Schandel:

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 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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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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Robert Oals

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) K172550

Device Name OEC Elite

Indications for Use (Describe)

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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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) Summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h).

Date:	August 22, 2017
Submitter:	GE OEC Medical Systems, Inc (GE Healthcare)384 Wright Brothers DriveSalt Lake City, Utah 84116
Primary Contact:	Rachel SchandelRegulatory Affairs LeaderTel: 385-237-7519Rachel.schandel@ge.com
Secondary Contact:	Helen PengRegulatory Affairs DirectorGE Medical Systems, LLCTel: 262-424-8222e-mail: hong.peng@ge.comJohn JaeckleChief Regulatory Affairs StrategistGE Medical Systems, LLCTel: 262-424-9547e-mail: john.jaeckle@ge.com

PRODUCT IDENTIFICATION

Device Trade Name:	OEC Elite
Regulation Name:	Image-intensified Fluoroscopic x-ray system
Regulation:	21CFR 892.1650
Classification:	Class II
Product Code:	OWB, JAA, OXO
Manufacturer / Design Location:	GE OEC Medical Systems, Inc (GE Healthcare)384 Wright Brothers Drive.Salt Lake City, Utah 84116
Manufacturing Location(s):	GE OEC Medical Systems, Inc (GE Healthcare)384 Wright Brothers Drive.Salt Lake City, Utah 84116

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Predicate Device:

Device Name:	OEC Elite
510(k) number:	K171565
Manufacturer:	GE OEC Medical Systems, Inc (same as proposed device)
Regulation Name:	Image-intensified Fluoroscopic x-ray system
Regulation:	21CFR 892.1650
Classification:	Class II
Product Code:	OWB, JAA, OXO

Marketed Device:

OEC Elite with Cardiac option is a Mobile Fluoroscopic C-arm Imaging System with modification to the predicate device OEC Elite (K171565) to offer the users the cardiac features. It is of comparable type and substantially equivalent to the predicate device OEC Elite. This 510(k)submission for the OEC Elite system with cardiac option includes the same intended use and substantially equivalent indications for use as its predicate device. The existing indications for use of OEC Elite are expanded to include the cardiac capability which is one of the current clinical uses of mobile c-arm systems that are well established in the medical community.

The subject device is labeled OEC Elite (name unchanged from the predicate device).

Device Description:

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The primary technology change for the subject device compared to the unmodified predicate, OEC Elite, is the introduction of the cardiac capabilities.

Intended Use

The OEC Elite Mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.

Indications for Use:

The OEC Elite mobile fluoroscopy system is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, cardiac, critical care, and emergency procedures.

Technology:

The OEC Elite with Cardiac option employs the same fundamental scientific technology as that of the predicate device OEC Elite (K171565).

The image chain including the X-Ray source and generator remain unchanged from that of the predicate OEC Elite. The primary change was in the software to implement the cardiac features. It re-uses the existing standard fluoroscopy modes as well as the vascular modes for cardiac imaging procedures. In order to optimize cardiac imaging, a Cardiac profile was added to the system. The Cardiac profile reduces blooming artifacts and enhances the visibility of moving features and vessels filled with a contrast agent when compared to not using the profile. The moving features are interventional devices such as guidewires, catheters, and stents that are inserted into vessels and manually manipulated through vessels to the surgical location in the heart. This is the most notable change for this submission. Additionally, a three pedal footswitch is also added which provides a dedicated pedal for Digital Cine pulse on OEC Elite systems with the cardiac option to assist the most typical cardiac workflow.

The modifications however, were built upon the existing robust and extensible software architecture, following the same design control process and software development lifecycle process that is compliant to IEC62304. The changes described above do not change the control mechanism, operating principle, energy type, or intended use from the predicate device.

Determination of Substantial Equivalence:

In addition to the verification and validation testing successfully completed as required by GE OEC Medical System's Quality Management System, additional engineering (non-Clinical) testing was performed to provide the requisite data to substantiate performance claims, the revised indications, and ultimately substantial equivalence.

The substantial equivalence was also based on software documentation for a "Moderate" level of concern device.

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Non-Clinical Testing

Verification and validation, including hazard mitigation has been executed with results demonstrating the OEC Elite mobile fluoroscopy system met design input and user needs.

The system has been tested and is compliant with the IEC 60601-1 Ed. 3 series, including IEC 60601-2-43. All applicable 21CFR Subchapter J performance standards are met. The OEC Elite system was developed under the GE OEC Medical Systems Quality Management System, including design controls, risk management and software development life cycle processes. The following quality assurance measures were applied to the development of the system:

Risk Analysis
Required Reviews
· Design Reviews
Testing on unit level (Sub System verification)
· Integration testing (System verification)
· Performance testing (Verification)
· Safety testing (Verification)
· Simulated use testing (Validation)

Additional engineering bench testing was performed including demonstration of system performance; and an imaging performance evaluation using anthropomorphic phantoms. All the image quality/performance testing identified for fluoroscopy found in FDA's "Information for Industry: X-ray Imaging Devices- Laboratory Image Quality and Dose Assessment. Tests and Standards" was performed with acceptable results.

The OEC Elite with Cardiac option was also evaluated for its performance per the FDA "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices' (SSXI). It was determined the modified system continues to comply to this guidance. The evaluation includes but not limited to the following performance metrics identified in the SSXI guidance, showing identical performance of the subject device to the predicate device OEC Elite:

DOE ●
Dynamic Range ●
Spatial Resolution (MTF, Limiting Resolution) ●
Temporal Resolution
Contrast Resolution ●
Beam Alignment
Dose Rate
Stability of the device characteristics over time
brightness uniformity ●
Fluoroscopy Frame Rate
. Reuse Rate

The substantial equivalence was also based on software documentation for a "Moderate" level of concern device.

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Clinical Testing

Because OEC Elite with the cardiac option does not change the system's intended use and represents equivalent technological characteristics, this type of change supports using scientific, established/standardized, engineering/physics-based performance testing, without inclusion of clinical images. Therefore, for OEC Elite with Cardiac option configurations, clinical images are not required to demonstrate the substantial equivalence to the predicate device.

Substantial Equivalence Conclusion:

The differences discussed in this submission do not introduce any adverse effects nor raise new questions of safety and effectiveness. Based on the successful verification and validation testing, additional engineering bench testing, conformance to standards, and development under GE OEC Medical System's Quality Management System, we believe that the OEC Elite with the cardiac option is of comparable type and substantially equivalent to the predicate device OEC Elite (K171565), and therefore is safe and effective for its intended use.

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.