The OEC One™ mobile C-arm system is designed to provide fluoroscopic and digital spot/film 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, critical care, and emergency procedures.

Device Description

The OEC One™ is a mobile C-arm x-ray system to provide fluoroscopic images of the patient during diagnostic, interventional, and surgical procedures such as orthopedic, gastrointestinal, endoscopic, urologic, neurologic, critical care, and emergency procedures. These images help the physician visualize the patient's anatomy and localize clinical regions of interest. The system consists of a mobile stand with an articulating arm attached to it to support an image display monitor (widescreen monitor) and a TechView tablet, and a "C" shaped

AI/ML Overview

Based on the provided text, the device in question is the OEC One™ mobile C-arm system, which is an image-intensified fluoroscopic X-ray system. The document is a 510(k) Premarket Notification Submission, indicating that the manufacturer is seeking to demonstrate substantial equivalence to a legally marketed predicate device rather than provide evidence of a novel device's safety and effectiveness.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of demonstrating substantial equivalence to the predicate device (K123603 OEC Brivo), rather than proving the device's de novo performance against specific clinical metrics as one might expect for a new AI/CADx device.

Here's an analysis of the provided information in response to your specific questions:

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

The document does not present a table of specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for a diagnostic output, as this is an imaging device rather than a diagnostic AI/CADx algorithm. Instead, the acceptance criteria are linked to demonstrating that the modified device maintains the same safety and effectiveness as the predicate device, especially considering the changes made (integration of mainframe/workstation, new display, software updates).

The "acceptance criteria" for this 510(k) appear to be:

Conformance to relevant safety and performance standards: IEC 60601-1 Ed. 3 series (including IEC60601-2-54 and IEC 60601-2-43), and all applicable 21 CFR Subchapter J performance standards.
Successful verification and validation: Demonstrating that the system met design input and user needs, including hazard mitigation.
Maintenance of comparable image quality: Assessed through engineering bench testing using anthropomorphic phantoms.
Compliance with software development requirements: For a "Moderate" level of concern device.

Acceptance Criteria Category	Reported Device Performance/Evidence
Safety and Performance Standards	- System 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.
Verification and Validation	- Verification and validation including hazard mitigation has been executed with results demonstrating the OEC One™ system met design input and user needs.- Developed under GE Healthcare's Quality Management System, including design controls, risk management, and software development life cycle processes.- Quality assurance measures applied: Risk Analysis, Required Reviews, Design Reviews, Unit Testing (Sub System verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), Simulated use testing (Validation).
Image Quality/Performance (Non-Clinical)	- Additional engineering bench testing on image performance using anthropomorphic phantoms was performed.- 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.
Software Compliance	- Substantial equivalence was also based on software documentation for a "Moderate" level of concern device.
Clinical Equivalence (No Clinical Study)	- "Because OEC One's modification based on the predicate device does not change the system's intended use and represent equivalent technological characteristics, clinical studies are not required to support substantial equivalence." This indicates the acceptance criterion for clinical performance was met by demonstrating the modifications did not impact the clinical function or safety relative to the predicate.

2. Sample size 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 images with human expert ground truth for an AI/CADx device. The testing described focuses on non-clinical engineering bench tests using anthropomorphic phantoms and system verification/validation against standards.
Data Provenance: The document states "Additional engineering bench testing on image performance using anthropomorphic phantoms was also performed." This implies a prospective generation of test data using physical phantoms, rather than retrospective or prospective clinical patient data. The country of origin for this testing is not explicitly stated beyond the manufacturer's location (China).

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. The testing described is primarily engineering and performance verification using phantoms and standards, not clinical image interpretation requiring expert radiologists to establish ground truth for a diagnostic task.

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

Not applicable, as there is no clinical image-based test set requiring human adjudication.

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: "Clinical testing: Because OEC One’s modification based on the predicate device does not change the system’s intended use and represent equivalent technological characteristics, clinical studies are not required to support substantial equivalence." This is not a study of AI assistance.

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

Not applicable. This is not an AI/CADx algorithm. The device itself is an X-ray imaging system. The software updates mentioned ("Adaptive Dynamic Range Optimization(ARDO) and motion artifact reduction") relate to image processing within the device itself, not a separate standalone diagnostic algorithm.

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

The "ground truth" for the device's performance is established through:
- Engineering benchmarks and physical phantom measurements: For image quality assessment against established standards (e.g., FDA's "Information for Industry: X-ray Imaging Devices - Laboratory Image Quality and Dose Assessment, Tests and Standards").
- Compliance with international safety and performance standards: IEC 60601 series, 21 CFR Subchapter J.
- Conformance to design specifications and user needs: Through verification and validation activities.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set in the conventional sense. The "software updates" mentioned are more likely based on engineering principles and signal processing than machine learning training.

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

Not applicable, as there is no explicit "training set" for an AI algorithm. Software development and calibration would typically rely on engineering specifications, physical models, and potentially empirical adjustments based on performance testing.

Summary

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November 9, 2017

GE Hualun Medical Systems Co., Ltd. Lifeng Wang Regulatory Affairs Manager No 1 Yong Chang North Road Beijing Economic Technological Development Zone Beijing, 100176, China

Re: K172700

Trade/Device Name: OEC One™ Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB. OXO. JAA Dated: September 7, 2017 Received: September 7, 2017

Dear Lifeng 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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 mediation-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 Oolo

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)

K172700

Device Name OEC One™

Indications for Use (Describe)

The OEC One mobile C-arm system is designed to provide fluoroscopic and digital spot/film images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, critical care, and emergency procedures.

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 One™

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:	Sep 7, 2017
Submitter:	GE 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 One™
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, OWB
Predicate Device(s):	K123603 OEC Brivo, 892.1650, OXO
Device Description:	The OEC One™ is a mobile C-arm x-ray system to providefluoroscopic images of the patient during diagnostic,interventional, and surgical procedures such as orthopedic,gastrointestinal, endoscopic, urologic, neurologic, critical care,and emergency procedures. These images help the physicianvisualize the patient's anatomy and localize clinical regions ofinterest. The system consists of a mobile stand with anarticulating arm attached to it to support an image display monitor(widescreen monitor) and a TechView tablet, and a "C" shapedPage 1 of 3
Intended Use:	The OEC One™ mobile C-arm system is intended to provide fluoroscopic and digital spot/film images of the patient anatomy, interventional tools/devices, and/or contrast agents during diagnostic, interventional, and surgical procedures.
Indications for Use	The OEC One™ mobile C-arm system is designed to provide fluoroscopic and digital spot/film 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, critical care, and emergency procedures.
Technology:	The modified OEC One™ employs the same fundamental scientific technology as that of the unmodified predicate device(K123603). The primary change for the subject device was to integrate the separate mainframe and workstation of the predicate device into a compact configuration to save the space of the operation room with smaller foot print and to offer better workflow, ergonomics and usability.Additionally, a separate articulating arm attached to the mobile stand was added to support the single widescreen image display monitor and a TechView tablet and to offer more degrees of freedom for easier positioning and maneuverability.The software was updated primarily to support changing to a single image display monitor, adding a new TechView tablet, consolidation of user interface, and modifying existing features for Adaptive Dynamic Range Optimization(ARDO) and motion artifact reduction. Additionally, the software was also modified to add an Alternating Current (AC) recovery feature and to comply to NEMA XR-27(User Quality Mode) requirement.
Determination ofSubstantial Equivalence:	Summary of Non-Clinical Testing:Verification and validation including hazard mitigation has beenexecuted with results demonstrating the OEC One™ system metdesign input and user needs.
	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.
	The OEC One™ system was developed under the GEHealthcare's Quality Management System, including designcontrols, risk management and software development life cycleprocesses. The following quality assurance measures wereapplied to the development of the system:Risk AnalysisRequired ReviewsDesign ReviewsUnit Testing (Sub System verification)Integration testing (System verification)Performance testing (Verification)Safety testing (Verification)Simulated use testing (Validation)
	Additional engineering bench testing on image performance usinganthropomorphic phantoms was also performed. All the imagequality/performance testing identified for fluoroscopy found inFDA's "Information for Industry: X-ray Imaging Devices-Laboratory Image Quality and Dose Assessment, Tests andStandards" was performed with acceptable results.
	The substantial equivalence was also based on softwaredocumentation for a "Moderate" level of concern device.
	Clinical Testing:Because OEC One's modification based on the predicate devicedoes not change the system's intended use and representequivalent technological characteristics, clinical studies are notrequired to support substantial equivalence.
Conclusion:	The differences discussed in this section do not introduce anyadverse effects nor raise new questions of safety andeffectiveness. Based on the successful verification and validationtesting, additional engineering bench testing, conformance tostandards, and development under GE Healthcare's QualityManagement System, we believe that the OEC One is ofcomparable type and substantially equivalent to the predicatedevice OEC Brivo Series (K123603).

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GE Healthcare

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510(k) Premarket Notification Submission- OEC One™

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GE Healthcare

510(k) Premarket Notification Submission- OEC One™

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.