The Definium AMX 700 X-Ray Unit is indicated for use in generating radiographic images of human anatomy. It is intended for general-purpose diagnostic procedures. It is capable of generating radiographic images on film or digitally. This device is not intended for mammographic applications.

Device Description

The GE Definium AMX 700 is a mobile x-ray system that enables the capture of radiographic images via a tethered digital detector or traditional film cassettes.

AI/ML Overview

The GE Definium AMX 700 is a mobile X-ray system. The information provided outlines its substantial equivalence to a predicate device rather than a study involving specific acceptance criteria for a new clinical performance claim. Therefore, much of the requested information regarding clinical studies, ground truth establishment, expert adjudication, and sample sizes is not applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Electrical Safety	Conforms with applicable medical device safety standards.
Radiation Safety	Conforms with applicable medical device safety standards.
Substantial Equivalence to GE AMX-4+ Mobile X-ray System	Utilizes similar technology and materials, comparable in key safety and effectiveness features, same basic design and construction, similar weight and power requirements, same intended uses.
Quality System Compliance	Design and development processes conform with 21 CFR 820, ISO 9001 and ISO 13485 quality systems.
Intended Use	Indicated for use in generating radiographic images of human anatomy for general-purpose diagnostic procedures (not mammographic applications). Capable of generating radiographic images on film or digitally.

2. Sample size used for the test set and the data provenance:

Not Applicable. No clinical test set involving patient data was required for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. No clinical test set requiring expert-established ground truth was part of this submission.

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

Not Applicable. No clinical test set requiring adjudication was part of this submission.

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 submission is for a conventional mobile X-ray system, not an AI-powered device. Therefore, no MRMC study or AI-related comparative effectiveness was conducted or reported.

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

Not Applicable. This is a hardware device, not an algorithm.

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

Not Applicable. No clinical ground truth was established for this submission as it relied on substantial equivalence. The "ground truth" for the device's acceptability was its conformance to safety standards and its functional equivalence to a legally marketed predicate device.

8. The sample size for the training set:

Not Applicable. This is a hardware device, not a machine learning model, so there is no training set in the context of AI. If "training set" refers to engineering testing or design validation, the document does not specify sample sizes for those internal processes.

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

Not Applicable. As above, there is no "training set" in the context of AI. For engineering and design validation, conformance to specifications and industry standards would be the "ground truth." The document states "The design and development processes of the manufacturer conform with 21 CFR 820, ISO 9001 and ISO 13485 quality systems," which implies internal validation against established criteria.

Summary of the Study (as described in the document):

The "studies" summarized are focused on electrical and radiation safety, confirming the device's conformance with applicable medical device safety standards. No clinical tests were required because the product is considered a combination of two already cleared devices for the US market (via 21 CFR Part 807). The substance of the submission revolves around demonstrating substantial equivalence to the predicate GE AMX-4+ Mobile X-ray System, meaning the new device has the same intended uses and fundamental scientific technology, and comparable safety and effectiveness features.

Summary

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K052897

October, 2005

Special 510(k) Premarket Notification

GE Healthcare Technologies - Definium AMX 700

NOV - 8 2005

Attachment B:

Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).

Image /page/0/Picture/4 description: This image shows information about GE Healthcare Technologies. It includes the company's address, which is P.O. Box 414, Milwaukee, WI 53201. The contact person is Mark Stauffer, who works in Safety and Regulatory Engineering, and his telephone number is 262-544-3217. The date prepared is October 5, 2005, and the device name is GE Definium AMX 700, which is a Mobile X-ray System, 21 CFR 892.1720, 90 IZL.

Marketed Device: GE AMX-4+ Mobile X-ray System, currently in commercial distribution.

Device Description: The GE Definium AMX 700 is a mobile x-ray system that enables the capture of radiographic images via a tethered digital detector or traditional film cassettes.

Indications for Use: The Definium AMX 700 is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.

Comparison with Predicate Device: The Definium AMX 700 is substantially equivalent to the currently marketed GE AMX-4+ mobile x-ray system. It utilizes similar technology and materials, and is comparable in key safety and effectiveness features. It uses the same basic design and construction and has similar weight and power requirement. It has the same intended uses as the predicate device.

Summary of Studies: The device has been evaluated for electrical, and radiation safety, and conforms with applicable medical device safety standards.

Olinical Tests: None required. This product is a combination of two devices already cleared for the US market via 21 CFR Part 807.

Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. Intended uses and fundamental scientific technology are the same as the legally marketed GE AMX-4+ mobile x-ray system. The design and development processes of the manufacturer conform with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with factory surveillance. Therefore, it is the opinion of GE Medical Systems LLC that the Definium AMX 700 is substantially equivalent with respect to safety and effectiveness to the unmodified GE devices currently cleared for market.

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Image /page/1/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" written around the edge. Inside the circle is a stylized image of an eagle with three lines representing its wings. The seal is black and white and appears to be a logo or emblem.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Mark Stauffer Safety & Regulatory Engineering GE HEALTHCARE TECHNOLOGIES Post Office Box 414 MILWAUKEE WI 53201

Re.: K052897

Trade/Device Name: GE Definium AMX 700 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: October 5, 2005 Received: October 14, 2005

Dear Mr. Stauffer

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 registrations, 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 advices 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 he Act or any Federal statues 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 (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.

NOV - 8 2005

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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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Special 510(k) Premarket Notification GE Healthcare Technologies - Definium AMX 700 October, 2005

STATEMENT OF INDICATIONS FOR USE

110528 97 510(k) Number (if known):

Device Name: Definium AMX 700

Indications for Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

し Prescription Use (Per 21 CFR 801-109)

OR Over-The-Counter Use_______________________________________________________________________________________________________________________________________________________

V Nancy C. Bearden

(Division Division of Reproductive. and Radiological Devi 510(k) Number

Regulation Number and Section

§ 892.1720 Mobile x-ray system.

(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.