The OEC 9800 Plus Digital Mobile Imaging System is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Examples of clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

Device Description

The OEC 9800 Plus is comprised of two mobile units: a C-arm stand and a workstation. The C-arm stand supports the high-voltage generator, x-ray controls, and a "C" shaped apparatus, which supports the x-ray tube on one end and an image intensifier on the other. The C-arm is designed to perform linear and rotational motions that allow the user to position the x-ray imaging components at various angles and distances with respect to the patient. The mobile workstation, supports image display monitors, image processing and recording devices.

AI/ML Overview

This 510(k) summary describes a legacy device that was submitted in 2002. At that time, the FDA's requirements for clinical performance studies and acceptance criteria were different than what they are today. The provided document focuses primarily on demonstrating substantial equivalence to a predicate device, adherence to safety standards, and providing a description of the device and its intended use. It does not contain information related to specific acceptance criteria, a clinical study with detailed performance metrics, sample sizes for test or training sets, expert qualifications, or adjudication methods in the way a modern submission would.

Therefore, I cannot fully answer your request based on the provided text. The document does not include a table of acceptance criteria and reported device performance because such performance studies for demonstrating efficacy in the modern sense were not generally required for this type of device at that time, especially when demonstrating substantial equivalence.

Here's an analysis of what information is available and what is not:

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

Not Available: The document does not define specific performance acceptance criteria (e.g., in terms of sensitivity, specificity, or image quality metrics) that were then measured and reported. The "performance" described is largely functional equivalence to the predicate and compliance with safety standards rather than clinical efficacy.

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

Not Available: No test set or clinical performance data is mentioned. The submission is based on substantial equivalence to a predicate device and compliance with safety standards.

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 Available: Since no test set or clinical study is described, there's no mention of experts or ground truth establishment.

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

Not Available: No test set 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

Not Available: No MRMC study was done, nor is AI assistance relevant to this device from 2002. This device is an X-ray imaging system, not an AI-powered diagnostic tool.

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

Not Available: This question is not applicable. The device is a fluoroscopic imaging system, not an algorithm.

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

Not Available: No clinical ground truth is described.

8. The sample size for the training set

Not Available: No training set is applicable to this type of device submission.

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

Not Available: Not applicable.

What the document does provide regarding "acceptance criteria" and "study":

The "study" in this context is the 510(k) Pre-market Notification process, which demonstrates "substantial equivalence" to a legally marketed predicate device. The "acceptance criteria" are implied to be:

Substantial Equivalence: The OEC 9800 Plus is substantially equivalent to the GE OEC Medical Systems OEC 9800 Digital Mobile Imaging System (the predicate). This is the primary "acceptance criterion" for a 510(k) submission.
Safety Compliance: The device is designed in accordance with established product safety requirements outlined in various national and international standards (e.g., Federal Performance Standard for Diagnostic X-ray Systems (21 CFR 1020.30-32), ANSI/NFPA 70 & 99, UL 2601, CSA-C22.2 No. 601.1-M90, IEC 60601 series, 93/42/EEC Annex 1). Testing against these standards would have been part of the internal validation process.
Indications For Use: The device performs its intended fluoroscopic and spot-film imaging functions for diagnostic, surgical, and interventional procedures, matching the predicate.
Technological Characteristics: The device shares similar technological characteristics (e.g., high-voltage x-ray generator, x-ray tube, image intensifier, digital image processing, image storage, video displays, C-arm design) with the predicate.

In summary, the provided document is a 510(k) summary from 2002 for an X-ray imaging system. It demonstrates substantial equivalence and compliance with safety standards rather than clinical performance based on quantitative metrics from a clinical study with defined acceptance criteria and ground truth, as typically seen for AI/ML-enabled devices today.

Summary

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APR 1 7 2002

K 021049

GE Medical Systems OEC

GE OEC Medical Systems, Inc. General Electric Company 384 Wright Brothers Drive, Salt Lake City, UT 84116-2862 http://www.gemedicalsystems.com

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

Date:

March 25, 2002

Name of Submitter:

GE OEC Medical Systems, Inc. 384 Wright Brothers Drive Salt Lake City, UT 84116 801-328-9300

Corresponding Official:

Bill Gislason. Vice President, Quality Assurance, Regulatory, and Reliability

Device Proprietary Name:

OEC 9800 Plus Digital Mobile Imaging System

Classification Name:

System, X-ray, Fluoroscopic, Image-Intensified - or System, X-ray, Mobile

Common/Usual Names:

Mobile C-arm, Fluoroscopic Imaging System

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Substantial Equivalence:

The OEC 9800 Plus is substantially equivalent to the following device that is currently marketed:

GE OEC Medical Systems OEC 9800 Digital Mobile Imaging System .
These devices are mobile C-arm type x-ray systems intended for fluoroscopic imaging. The systems each include a high-voltage x-ray generator and control. x-ray tube, image intensifier, video image displays, digital image processing and image storage capability, as well as conventional spot-film capability.

Device Description:

Indications For Use

The OEC 9800 Plus is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

User Characteristics

The device is used by health care professionals such as physicians, surgeons, cardiologists, radiologists and technologists in hospitals, outpatient clinics and other clinical environments. It is expected that the device will be used on a daily basis. Users are trained by GE OEC applications speciallsts and/or qualified site personnel in the proper use of the device. The device labeling stipulates that only properly trained persons operate this equipment.

General Description

Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCRs. Video outputs are compatible with RS-170 format for domestic markets, CCIR format for international markets, and DICOM 3.0. An auxiliary connection is provided for a Medrad angiographic injector system to facilitate synchronized acquisition of angiographic images during contrast media injection.

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Standards:

The OEC 9800 Plus is designed in accordance with product safety requirements established in the following standards:

· Federal Performance Standard for Diagnostic X-ray Systems (21 CFR 1020.30-32)
· ANSI/NFPA 70 & 99 National Electrical Code and Standard for Health Care Facilities
· UL 2601 Medical Electrical Equipment
CSA-C22.2 No. 601.1-M90 . Medical Electrical Equipment
· IEC 60601-1, Medical Electrical Equipment, General Requirements for Safety
· IEC 60601-1-2, Medical Electrical Equipment, General Requirements for Safety, Electromagnetic Compatibility
· IEC 60601-1-3, Medical Electrical Equipment, Radiation Protection in Diagnostic X-ray Equipment
· IEC 60601-2-7. Medical Electrical Equipment, Safety of HV/X-ray Generators
· IEC 60601-2-32, Medical Electrical Equipment, Safety of Associated X-ray Equipment
· 93/42/EEC Annex 1 Essential Requirements of the Medical Devices Directive

This concludes this 510(k) Summary.

Bill Dickson

Vice President, Quality Assurance, Regulatory, and Reliability Bill Gislaso GE OEC Medical Systems, Inc.

WAG/dh

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles in blue, layered on top of each other, creating a sense of depth and connection.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Mr. Bill Gislason Vice President, Quality Assurance. Regulatory and Reliability GE OEC Medical Systems, Inc. 384 Wright Brothers Drive SALT LAKE CITY UT 84116-2862

MAY 22 2012

Re: K021049

Trade/Device Name: OEC 9800 Plus Digital Mobile Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB. JAA and OXO Dated: March 25, 2002 Received: April 1. 2002

Dear Mr. Gislason:

This letter corrects our substantially equivalent letter of November 14, 2011.

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

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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 predicate 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

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

Enclosure

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510(k) Nolification

GE OEC Medical Systems, Inc.

OEC 9800 Plus

Indications For Use Statement

GE OEC Medical Systems, Inc. Applicant:

510(k) No. (if known):

OEC 9800 Plus Digital Mobile Imaging System Device name:

The OEC 9800 Plus Digital Mobile Imaging System is designed to Indications for use: provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Examples of clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter_**_

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number _**_ K021049

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.