The OEC® 9900 Elite is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, vascular, cardiac, critical care and emergency room procedures.

Device Description

The OEC® 9900 Elite is a system used to assist trained physicians. The system is used to provide X-Ray images while the physician performs a medical procedure. Images from the system help the physician to visualize the patients' anatomy. This visualization helps to localize surgical regions of interest and pathology. The images provide real-time visualization and records of pre-surgical anatomy, in vivo-surgical activity and post surgical outcomes. The system is composed of two primary physical elements. The first is referred to as the "C-Arm" because of its "C" shaped image gantry; the second referred to as the "Workstation" because this is the primary user interface to the system.

AI/ML Overview

The provided text describes the GE OEC 9900 Elite Mobile Fluoroscopic Imaging System and its 510(k) premarket notification. However, it does not contain information about specific acceptance criteria or a study proving the device meets said criteria in the way typically expected for performance-based medical device submissions (e.g., accuracy, sensitivity, specificity, etc., with detailed statistical analysis).

The submission focuses on establishing substantial equivalence to a predicate device (OEC 9900 Elite, K082781) by stating that the modified device "employs the same fundamental scientific technology" and that "engineering testing and standards compliance testing were successfully conducted and did not raise any new safety questions or concerns or identify new risks."

Therefore, I cannot fulfill most of your request from the provided text, as the specific details you're asking for are not present.

Here's an attempt to answer based on the available information, highlighting what is not present:

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

Information Not Provided: The submission does not specify numerical acceptance criteria (e.g., for image quality, resolution, contrast, etc.) nor does it report specific performance metrics against such criteria. The claim is substantial equivalence to a predicate device, implying that the performance is at least as good as 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)

Information Not Provided: The document does not describe any specific "test set" of patient data or images used for performance evaluation. The "engineering testing and standards compliance testing" mentioned would typically involve technical performance verification (e.g., calibration, image quality phantoms) rather than clinical image interpretation by humans.

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)

Information Not Provided: Since no clinical test set is described, there's no mention of experts or ground truth establishment in this context.

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

Information Not Provided: No clinical test set or adjudication method is described.

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

Information Not Provided: This device is a fluoroscopic imaging system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission and is not mentioned.

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

Information Not Provided: This device is a direct imaging system, not an algorithm. Its performance is inherent to its imaging capabilities, with a human operator (physician or system operator) in the loop during its intended use. It does not have a "standalone algorithm" performance to report.

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

Information Not Provided: No clinical ground truth is discussed in this submission. The "ground truth" for showing substantial equivalence relies on technical specifications and adherence to standards for the device's components and overall function, compared to the predicate.

8. The sample size for the training set

Information Not Provided: This device is not an AI/ML algorithm that requires a "training set."

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

Information Not Provided: This device is not an AI/ML algorithm, so there is no training set or associated ground truth establishment.

Summary based on the provided text:

The GE OEC 9900 Elite Mobile Fluoroscopic Imaging System K120613 submission relies on demonstrating substantial equivalence to a predicate device (OEC 9900 Elite, K082781) rather than presenting a de novo performance study against explicit acceptance criteria.

The key statements regarding performance and safety are:

"The modified OEC® 9900 Elite device employs the same fundamental scientific technology as the predicate device."
"Engineering testing and standards compliance testing were successfully conducted and did not raise any new safety questions or concerns or identify new risks."
"GE Healthcare considers the modified GE OEC® 9900 Elite to be safe, as effective, and performance is substantially equivalent to the predicate device OEC® 9900 Elite (K082781)."

This type of 510(k) submission typically does not include the detailed clinical performance studies, reader studies, or AI algorithm evaluation metrics you requested. The "study" referenced would be the engineering and standards compliance testing that validated the modifications did not alter the fundamental safety or effectiveness demonstrated by the predicate device.

Summary

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APR - 6 2012

Image /page/0/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 circle. The letters and the circle are black, creating a strong contrast. The logo is a well-known symbol associated with the multinational conglomerate corporation.

GE Healthcare 510(k) Premarket Notification Submission

K120613

510(k) Summary

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

February 24, 2012 Date:

Submitter:

GE Healthcare Surgery 384 Wright Brothers Drive Salt Lake City, UT 84116

Primary Contact Person:

Gerald Buss Director Regulatory Affairs GE Healthcare Surgery Phone: (801) 517-6591 Fax: (801) 517-6566

Secondary Contact Person:

Karen Russell Regulatory Affairs Leader GE Healthcare Surgery Phone: (801) 536-4930 Fax: (801) 517-6566

Device: (Trade Name): Common/Usual Name: Classification Names: Product Code:

OEC® 9900 Elite

Mobile Fluoroscopic Imaging System

21 CFR 892.1650 Image-intensified fluoroscopic x-ray system

90OXO and 90JAA

K082781 OEC® 9900 Elite Predicate_Device(s):

Device Description:

The system is composed of two primary physical elements. The first is referred to as the "C-Arm" because of its "C" shaped image gantry; the second referred to as the "Workstation" because this is the primary user interface to the system.

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GE Healthcare 510(k) Premarket Notification Submission

The system is used in different surgical procedures. Orthopedic physicians may use the system to help perform hip replacements and reconstructions of badly fractured bones. Orthopedic physicians may use the system to help perform hip replacements and reconstructions of badly fractured bones. Vascular physicians may use the system to perform blood flow studies.

Cardiologists may use the system to help see if there are blockages in some of the key arteries supplying blood to the heart. The procedures that these physicians perform are broadly referred to as "Clinical Applications". The system is controlled and run in a clinical environment.

The system employs X-Rays as its imaging technology. An X-Ray Generator located in the base of the C-Arm creates high voltage. High voltage is carried to the X-Ray tube across a set of cables. The X-Ray tube emits X-Rays that are directed toward the patient under the control of the operator. The Physician defines the desired view for the specific clinical procedure and directs the operator. The X-Rays pass through the patient and are captured by the image intensifier (II). Image intensifier images are captured by a camera and displayed on the image monitor located on the Workstation. The Physician or system operator view the images as they are displayed and thev may choose to store the images for later review.

In order to perform these procedures different views of the human anatomy are required, so the system is designed with the ability to rotate and translate the C-Arm's image gantry to obtain different viewing angles. In addition since there is variation in thickness and density of the anatomy the system operator has the ability to adjust the X-Ray Generator technique, image size and orientation

urologic, orthopedic, neurologic, vascular, cardiac, critical care

to account for the anatomical differences. Intended Use: The OEC® 9900 Elite Mobile Fluoroscopy System is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy,

Technology:

The modified OEC® 9900 Elite device employs the same fundamental scientific technology as the predicate device.

and emergency room procedures.

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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. There are decorative swirls around the outside of the circle. The logo is black and white.

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GE Healthcare 510(k) Premarket Notification Submission

Determination of Substantial Equivalence:

The OEC® 9900 Elite and its application comply with voluntary standards as detailed in Section 9, of this premarket submission. The modifications from the predicate device OEC® 9900 Elite were completed in accordance with GE Healthcare Surgery's quality management system design controls. Engineering testing and standards compliance testing were successfully conducted and did not raise any new safety questions or concerns or identify new risks. Information is included with this 510(k) submission that supports this determination.

Conclusion:

GE Healthcare considers the modified GE OEC® 9900 Elite to be safe, as effective, and performance is substantially equivalent to the predicate device OEC® 9900 Elite (K082781).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Mr. Gerald Buss Director Regulatory Affairs GE Healthcare Surgery 384 Wright Brothers Drive SALT LAKE CITY UT 84116

Re: K120613

Trade/Device Name: GE OEC 9900 Elite Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, OXO and JAA Dated: March 15. 2012 Received: March 16, 2012

Dear Mr. Buss:

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

APR - 6 2012

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Enclosure

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 needicate 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 Division of Small Manufacturers, 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

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

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GE Healthcare 510(k) Premarket Notification Submission

INDICATIONS FOR USE

510(k) Number (if known):

Device Name: GE OEC 9900 Elite

Indications for Use:

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Radiological Devices
Office ofi In Vitro Diagnostic Device Evaluation and Safety
K120613

BIOK

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.