The Centrion 500 C-Arm System is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic and surgical procedures. Clinical applications include, but are not limited to, general surgery, gastro-intestinal, urologic, orthopedic, neurologic, vascular, and emergency room procedures. The system may also be used for other imaging applications at the physician's discretion.

Device Description

The Centrion 500 C-Arm System. Is a digital C-Arm-type fluoroscopic system. It includes nearly every feature that exists on currently marketed System: "It interacts noany, while enclosing those features in a products, nact system, and adding a Real-Time Pulsed Fluoroscopy more offical by John Pulsed Fluoroscopy mode can significantly reduce the dose to the patient, without compromising image quality. Dose reductions of up to 85% are possible.

AI/ML Overview

This 510(k) summary for the Centrion 500 C-Arm System focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and adherence to performance standards for X-ray devices. It does not contain information about a study that would typically establish acceptance criteria and device performance in the manner of an AI/software device.

Here's an analysis based on the provided text, highlighting what is and is not present given the request's scope for an AI/software device:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Technological Equivalence	Similar technological characteristics to predicate device.	Both proposed and predicate devices use digital image receptors and standard image manipulation software.	This is the primary "performance" metric implied by the 510(k) process for this type of device. The system is considered equivalent if its core functions match the predicate.
Safety and Performance Standards	Compliance with relevant X-ray device standards (e.g., IEC-60601 series, 21 CFR 1020).	"Testing to the requirements of consensus standards was carried out to assure equivalence." (Specific test results or performance metrics against these standards are not detailed in the summary).	General statement of compliance; no quantitative performance metrics.
Dose Reduction	N/A (No specific quantifiable acceptance criteria provided for dose reduction).	"Real-Time Pulsed Fluoroscopy mode can significantly reduce the dose to the patient, without compromising image quality. Dose reductions of up to 85% are possible."	This is a claimed capability and potential benefit, not an explicit acceptance criterion with a specific threshold that was "met" with documented evidence in this summary. The summary states it's possible, not that it was definitively demonstrated as an acceptance criterion for this submission.
Image Quality	N/A (No specific quantifiable acceptance criteria provided for image quality).	"without compromising image quality" (in relation to dose reduction).	This is a qualitative claim. No objective metrics or studies on image quality preservation are detailed in the submitted summary as acceptance criteria.
Intended Use	Device can provide fluoroscopic and spot-film imaging for specified clinical applications.	Device is "designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic and surgical procedures." (Clinical applications listed).	This is an assertion of functionality and purpose, assumed to be met by virtue of the device's design and technological characteristics being similar to the predicate.

Based on the provided K050866 510(k) summary, the following information is either not applicable, not detailed, or not explicitly stated as per your request, which seems more tailored to a software/AI device performance study.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not provided. This 510(k) summary primarily demonstrates substantial equivalence through technological comparison and compliance with electrical/radiation safety standards for an imaging hardware device. It does not describe a clinical performance study with a "test set" of images or patient data in the way an AI/software device would. The "testing" mentioned refers to compliance with device standards, not a diagnostic accuracy study.
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/Not provided. No "ground truth" establishment by experts for a test set is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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/Not provided. This is a hardware imaging system, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not provided. This is not an algorithm-only device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not provided.
The sample size for the training set:
- Not applicable/Not provided. This device is a C-arm system, not an AI model requiring a training set.
How the ground truth for the training set was established:
- Not applicable/Not provided.

Summary of the 510(k) approach:

This 510(k) submission for the Centrion 500 C-Arm System does not describe a performance study with a test set, ground truth, or expert review in the context of an AI/software medical device. Instead, it demonstrates "substantial equivalence" based on:

Comparison to a Legally Marketed Predicate Device: The Centrion 500 C-Arm System is presented as substantially equivalent to the General Electric OEC FLEXIVIEW 8800 Digital Mobile Imaging System (K003837).
Similar Technological Characteristics: Both devices utilize a digital image receptor and standard image manipulation software for real-time digital fluoroscopic images.
Compliance with Recognized Standards: The device was tested against several IEC and CFR standards pertaining to X-ray devices (e.g., IEC-60601-1-3, IEC-60601-2-7, IEC-60601-2-28, IEC-60601-2-32, 21 CFR 1020). The fulfillment of these standards serves as the "study" proving its safety and basic performance characteristics relative to established norms for such devices, rather than a clinical accuracy study.
Identical Intended Use: The intended uses for diagnostic and surgical fluoroscopic/spot-film imaging are identical to the predicate.

The "acceptance criteria" in this context are primarily the successful demonstration of substantial equivalence by meeting regulatory requirements, technological similarity to the predicate, and adherence to relevant safety and performance standards for X-ray equipment. There are no clinical performance metrics or studies involving patient data or expert interpretation detailed in this summary.

Summary

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510(k) Summary KOSO866

Centrion 500 C-Arm System

Classification Name: Image-Intensified Fluoroscopy Device 21 CFR 892.1650

Companiy. OsteoSys

Phone: (+082) 2-2041-5600 Fax: (+082) 2-2041-5602

Contact: :Henry Jang, Prepared: December 15, 2004

LEGALLY MARKETED PREDICATE DEVICE A.

The Centrion 500 C-Arm System is substantially equivalent to the General Electric OEC FLEXIVIEW 8800 Digital Mobile Imaging System (K003837).

DEVICE DESCRIPTION B.

INTENDED USE C.

The Centrion 500 C-Arm System is designed to provide fluoroscopic and I he Sonthon 800 of the patient during diagnostic and surgical procedures. Clinical applications include, but are not limited to, general surgery, Olintour upplications in thopedic,neurologic, vascular, and emergency gastro inteotinal, archogio, exhoply be used for other imaging applications at the physician's discretion.

SUBSTANTIAL EQUIVALENCE SUMMARY D.

The Centrion 500 C-Arm System is a medical device, and it has the The Ochthon 000 our as the legally marketed predicate device. The Same indications for acc as the same technological characteristics Centrion 300 0-Amil Oyets. This premarket notification has described most

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characteristics of the Centrion 500 C-Arm System in sufficient detail to onaracteribated on lequivalence.1 For a few characteristics, such as electrical safety, testing to the requirements of consensus standards was carried out to assure equivalence

TECHNOLOGICAL CHARACTERISTICS E.

The technological characteristics of the proposed and predicate devices are Both use a digital image receptor and standard image the same. നം - oulation software tools to display real-time digital fluoroscopic images.

ii TESTING

The device was tested to the requirements of the following several standards that pertain to x-ray devices:

IEC-60601-1-3 - General Requirements for Radiation Protection in Diagnostic X-Ray Equipment.

IEC-60601-2-7 - Particular Requirements for the Safety of High-Voltage Generators of Diagnostic X-Ray Generators

IEC-60601-2-28 - Particular Requirements for the Safety of X-Ray Source Assemblies and X-Ray Tube Assemblies for Medical Diagnosis.

IEC-60601-2-32 -- Particular Requirements for the Safety of Associated Equipment of X-Ray Equipment.

21 CFR 1020

CONCLUSIONS G.

This pre-market notification has demonstrated Substantial Equivalence as defined and understood in Sections 513(f)(1) and 513(i)(1) of the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

The meaning of the terms "substantial equivalence" and "substantially equivalent" 1 as used in this 510(k) is limited to the way they are defined in, and used by FDA in as used in this 510(K) is linked to the way 170) (1) of the Federal Food, Drug, and Cosmetic Act.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines extending from its head, representing health, hope, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

APR 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OsteoSys. % T. Whit Athey, Ph.D. Senior Consultant The Health Policy Resources Group, LLC 2305 Gold Mine Road, Suite 200 BROOKVILLE MD 20833-2233

Re: K050866 Trade/Device Name: Centrion 500 C-Arm System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: April 5, 2005 Received: April 5, 2005

Dear Dr. Athey:

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 pror 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

KoS0866 510(k) Number (if known):

Centrion 500 C-Arm System Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Centrion 500 C-Arm System is designed to provide fluoroscopic and spot-film imaging of the patient i he Centrion 500 C-Arm System is designed to provide , but are not limited to, general during diagnostic and surgical procedures. Oilfical upplications inc. and emergency room procedures.
surgery, gastro-intestinal, urologic, orthopedic,neurologic, vascularios surgery, gastro-intestinal, urologic, orthopodic,hoaler, the physician's discretion.

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

Over-The-Counter Use __ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Nancy Brandon

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

000051

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.