The AMX Navigate is intended to take exposures utilizing film, computed radiography (CR), or wireless detectors, which are intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).

AMX Navigate is a self-contained; battery operated mobile radiographic imaging system designed to generate diagnostic radiographic images (medical x-rays) that may increase the ability to detect disease or injury early enough for a medical problem to be managed, treated, or cured. Medical x-rays are used in many types of examinations and procedures, some examples include: x-ray radiography (to find orthopedic damage, tumors, pneumonias, foreign objects). The AMX Navigate is indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. Its mobility enables general-purpose radiographic procedures throughout the clinical environment, or as needed within the emergency, intensive care, premature birth ward, cardiac and operating departments, for patients that may not be able to be moved or in cases where it is unsafe or impractical to a traditional RAD room.

The system is indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position.

This device is not intended for mammographic applications.

The AMX Navigate incorporates AutoGrid, which is an optional image processing software installed as a part of the systems Helix image processing software. AutoGrid can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images by reducing the effects of scatter radiation.

Device Description

The AMX Navigate is intended to take exposures, using a wired or remote exposure switch, utilizing film, computed radiography (CR), or cleared wireless radiographic detectors, which are intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).

The AMX Navigate system is indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. Its mobility enables general-purpose radiographic procedures throughout the clinical environment, or as needed within the emergency, intensive care, premature birth ward, cardiac and operating departments, for patients that may not be able to be moved or in cases where it is unsafe or impractical to move them to a traditional RAD room.

The incorporation of an optional collapsible column allows for improved workflow by delivering a less obstructed view when driving the system and includes a motion assist to reduce user efforts when driving the column vertically.
The system is indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position.
This device is not intended for mammographic applications.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the AMX Navigate device, based on the provided FDA 510(k) summary:

The AMX Navigate is a mobile x-ray system. The 510(k) pertains to a modification: the incorporation of an optional collapsible column and an improved algorithm for previewing images and image processing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Safety	No new potential safety risks introduced by the modifications.	Verified and validated through risk analysis and testing. Mitigations were verified and validated with acceptable results.
Effectiveness	The device remains as effective as the predicate device.	Design verification and validation testing confirmed that effectiveness has not been affected. Test plans and results executed with acceptable results.
Performance	The device performs as well as the predicate device.	Design verification and validation testing confirmed that performance is substantially equivalent. Test plans and results executed with acceptable results.
Technological Characteristics	The modified device maintains the same fundamental scientific technology as the predicate and exhibits similar characteristics.	The AMX Navigate employs the same fundamental scientific technology as the predicate device (battery-operated mobile x-ray system, captures exposures using film, CR plates, or wireless detector). The modification is specifically for a collapsible column and improved image processing algorithm, not a change in core x-ray technology.
Intended Use	The intended use remains the same as the predicate device.	The intended use is the same as the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary explicitly states:

"The subject of this premarket submission, AMX Navigate, did not require clinical studies to support substantial equivalence of incorporating an optional collapsible column."

Therefore, there is no information provided regarding a test set sample size or data provenance for clinical performance evaluation. The evaluation was based on non-clinical design verification and validation testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

As no clinical studies were deemed necessary, there is no information provided regarding experts establishing ground truth for a clinical test set. The evaluation relied on engineering and quality assurance measures.

4. Adjudication Method for the Test Set

Since no clinical studies were conducted, no adjudication method was described for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states that clinical studies were not required. Therefore, no MRMC comparative effectiveness study was done to assess human reader improvement with or without AI assistance. The "AutoGrid" feature is an image processing software component, not an AI assistance for human readers in the context of interpretation.

Effect Size of Human Readers with AI vs. without AI Assistance: Not applicable, as no such study was performed or reported.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

The "AutoGrid" is an optional image processing software intended to improve image contrast. While it's an algorithm, the document does not describe a standalone performance study in the context of diagnostic accuracy without human interpretation. Its performance is assessed as a component of the overall image quality improvement, which is then presumably interpreted by a human. The focus of the submission is on the safety and effectiveness of the mechanical and software modifications to the mobile x-ray system itself, particularly the collapsible column.

7. The Type of Ground Truth Used

For the non-clinical design verification and validation, the "ground truth" would be established by:

Engineering specifications and design requirements: For hardware components and their functionality (e.g., column collapse mechanism, travel range).
Physics and image quality metrics: For evaluating the effects of the new image processing algorithm (AutoGrid) on contrast improvement and scatter reduction, likely through phantoms and objective measures.
Risk analysis and mitigation effectiveness: Demonstrating that identified risks are controlled.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" in the context of machine learning. The "AutoGrid" is described as an image processing software rather than a deep learning AI model that would typically require a training set. If it is an AI model, the training set information is not disclosed in this summary.

9. How the Ground Truth for the Training Set Was Established

As no training set is described, this information is not available.

Summary

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April 28, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

GE Medical Systems, LLC % Martha Kamrow, Ph.D. Senior Regulatory Affairs Leader 3000 N. Grandview Blvd. WAUKESHA WI 53188

Re: K210982

Trade/Device Name: AMX Navigate Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL, MQB Dated: March 31, 2021 Received: April 1, 2021

Dear Dr. Kamrow:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K210982

Device Name AMX Navigate

Indications for Use (Describe)

This device is not intended for mammographic applications.

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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510(k) Summary

K210982

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

DateSubmitted:	March 31 2021
Submitter:	GE Medical Systems, LLC
	3000 N. Grandview BlvdWaukesha, WI 53188, USA
Primary ContactPerson:	Martha KamrowSenior Regulatory Affairs LeaderGE Healthcare262-548-2673Martha.Kamrow@ge.com
SecondaryContact Person:	Diane UriellRegulatory Affairs Senior DirectorGE Healthcare262-290-8218Diane.Uriell@ge.com
Device TradeName:	AMX Navigate
Common/UsualName:	Mobile X-ray system
Regulation,Classification,and ProductCode:	Regulation Name: Mobile X-Ray System
	Regulation: 21 CFR 892.1720
	Classification: Class II
	Product Codes: IZL, MQB
PredicateDevice(s):	Optima XR240amx with RFID (K182234)
	Regulation Name: Mobile X-Ray System
	Regulation: 21 CFR 892.1720
	Classification: Class II
	Product Codes: IZL, MQB
DeviceDescription:	The AMX Navigate is intended to take exposures, using a wired or remoteexposure switch, utilizing film, computed radiography (CR), or clearedwireless radiographic detectors, which are intended to replaceradiographic film screen systems in all general purpose diagnosticprocedures, for digital radiography (DR).
	AMX Navigate is a self-contained; battery operated mobile radiographicimaging system designed to generate diagnostic radiographic images(medical x-rays) that may increase the ability to detect disease or injuryearly enough for a medical problem to be managed, treated, or cured.Medical x-rays are used in many types of examinations and procedures,some examples include x-ray radiography (to find orthopedic damage,tumors, pneumonias, foreign objects).
	The AMX Navigate system is indicated for use on adult and pediatricpatients for general-purpose diagnostic radiographic examinations andprocedures. Its mobility enables general-purpose radiographic proceduresthroughout the clinical environment, or as needed within the emergency,intensive care, premature birth ward, cardiac and operating departments,for patients that may not be able to be moved or in cases where it isunsafe or impractical to move them to a traditional RAD room.
	The incorporation of an optional collapsible column allows for improvedworkflow by delivering a less obstructed view when driving the system andincludes a motion assist to reduce user efforts when driving the columnvertically.The system is indicated for taking radiographic exposures of the skull,spinal column, chest, abdomen, extremities, and other body parts with thepatient sitting, standing, or lying in the prone or supine position.This device is not intended for mammographic applications.
Intended Use /Indications forUse:	The AMX Navigate is intended to take exposures utilizing film, computedradiography (CR), or wireless detectors, which are intended to replaceradiographic film screen systems in all general purpose diagnosticprocedures, for digital radiography (DR).
	AMX Navigate is a self-contained; battery operated mobile radiographicimaging system designed to generate diagnostic radiographic images
	(medical x-rays) that may increase the ability to detect disease or injuryearly enough for a medical problem to be managed, treated, or cured.Medical x-rays are used in many types of examinations and procedures,some examples include x-ray radiography (to find orthopedic damage,tumors, pneumonias, foreign objects).
	The AMX Navigate is indicated for use on adult and pediatric patients forgeneral-purpose diagnostic radiographic examinations and procedures. Itsmobility enables general-purpose radiographic procedures throughout theclinical environment, or as needed within the emergency, intensive care,premature birth ward, cardiac and operating departments, for patientsthat may not be able to be moved or in cases where it is unsafe orimpractical to move them to a traditional RAD room.
	The system is indicated for taking radiographic exposures of the skull,spinal column, chest, abdomen, extremities, and other body parts with thepatient sitting, standing, or lying in the prone or supine position.
	This device is not intended for mammographic applications.
	The AMX Navigate incorporates AutoGrid, which is an optional imageprocessing software installed as a part of the systems Helix imageprocessing software. AutoGrid can be used in lieu of an anti-scatter grid toimprove image contrast in general radiographic images by reducing theeffects of scatter radiation.
Technology:	The AMX Navigate employs the same fundamental scientific technology asthe predicate device. They are both battery operated mobile x-raysystems that capture exposures utilizing film, CR plates, or a wirelessdetector. The intended use is the same between the AMX Navigate andthe predicate device. The AMX Navigate did not change the input power,battery subsystem, drive subsystem, x-ray generation, and exposurecontrol from the predicate devices. The difference being introduced is amodification to the hardware and software to incorporate an optionalcollapsible column. The incorporation of an optional collapsible columnallows for improved workflow by delivering a less obstructed view whendriving the system and includes a motion assist to reduce user efforts whendriving the column vertically. The hardware on the AMX Navigate has beenmodified to include the optional collapsible column and a horizontal armassembly to provide a longer travel range for the tube/collimator. Thesoftware on the AMX Navigate has been modified to support the optionalcollapsible column and improves the algorithm for previewing images andimage processing
Determinationof SubstantialEquivalence:	Summary of Non-Clinical Tests:The following quality assurance measures were applied to thedevelopment of the AMX Navigate system:
Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Performance testing (Verification) Safety testing (Verification) Simulated use testing (Validation) New risks were identified for incorporating the optional collapsible column and associated software into the AMX Navigate. These risks were reviewed and mitigated with design controls and labeling. The mitigations were verified and validated as a part of the design verification and validation testing that has been executed with acceptable results.Summary of Clinical Tests:The subject of this premarket submission, AMX Navigate, did not require clinical studies to support substantial equivalence of incorporating an optional collapsible column.Design verification and validation testing was performed to confirm that the safety and effectiveness of the device has not been affected. The test plans and results have been executed with acceptable results.
Conclusion:	The AMX Navigate incorporates an optional collapsible column allowing for improved workflow by delivering a less obstructed view when driving the system and includes a motion assist to reduce user efforts when driving the column vertically. This update to this system does not result in any new potential safety risks, it has the same technological characteristics, and perform as well as the devices currently on the market.After analyzing design verification and validation testing on the bench it is the conclusion of GE Healthcare that the AMX Navigate to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

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GE Healthcare 510(k) Premarket Notification Submission

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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.