The Optima XR240amx 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).

Optima XR240amx is a seff-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 Optima XR240amx 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 system is indicated for taking radiographic exposures of the skull, spinal column, 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 Optima XR240amx 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 Optima XR240amx with AutoGrid 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).

Optima XR240amx with AutoGrid 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 Optima XR240amx with AutoGrid 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 AutoGrid software into the Helix Image Processing software on the Optima XR240amx allows the user to improve the image contrast in general radiographic images by reducing the effects of scatter radiation in lieu of incorporating a physical anti-scatter grid onto the cleared wireless detectors.

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 an analysis of the acceptance criteria and the study conducted for the Optima XR240amx with AutoGrid, based on the provided text:

Device: Optima XR240amx with AutoGrid - an image processing software feature that can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images.

Goal of the Study: To demonstrate that AutoGrid software can achieve image contrast equivalent to that of a physical anti-scatter grid.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a structured table format with corresponding reported performance metrics. Instead, it describes:

Ability to achieve equivalent image contrast: The core performance goal is to demonstrate that AutoGrid can provide image contrast equivalent to physical anti-scatter grids.
Scatter reduction: The software's mechanism is to estimate and subtract scatter radiation to improve image quality.
Strength options: The software offers three strength options (Low, Medium, High) corresponding to physical 6:1, 8:1, and 12:1 ratio grids, respectively.

However, the document states the conclusion regarding device performance:

Acceptance Criterion (Implicit)	Reported Device Performance
Achieve image contrast equivalent to a physical anti-scatter grid.	"Bench testing was sufficient to demonstrate that the AutoGrid software can achieve image contrast equivalent to that of a physical anti-scatter grid." "The AutoGrid software that is incorporated into the Helix Image Processing software of the Optima XR240amx can be used in lieu of a physical anti-scatter grid... to improve image contrast in general radiographic images by reducing the effects of scatter radiation. 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 Optima XR240amx with AutoGrid to be as safe, as effective, and performance is substantially equivalent to the predicate devices."
Operation with different scatter reduction strengths.	"The AutoGrid software can be configured at three global strength options (Low, Medium, and High). The strength indicates the amount of scatter reduction that will occur during image processing. The Low strength corresponds to the amount of scatter reduction that would occur through using a physical 6:1 ratio grid, Medium a physical 8:1 ratio grid, and High a physical 12:1 ratio grid."
Maintain safety and effectiveness.	"Safety testing (Verification)" and "Simulated use testing (Validation)" were performed. "New risks were identified... These risks were reviewed and mitigated... The mitigations were verified and validated as a part of the design verification and validation testing that has been executed with acceptable results." "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."
Compliance with relevant standards (ES60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-54, IEC 62366, PS 3.1 - 3.20 DICOM set (Radiology)).	The modification and its applications "comply with voluntary standards" listing these standards.

2. Sample Size for the Test Set and Data Provenance

The document states: "The subject of this premarket submission, Optima XR240amx with AutoGrid, did not require clinical studies to support substantial equivalence... Bench testing was sufficient to demonstrate that the AutoGrid software can achieve image contrast equivalent to that of a physical anti-scatter grid."

Therefore, there was no test set of patient data (images) in the traditional clinical sense. The testing was "bench testing," meaning it likely involved controlled experimental setups using phantoms or simulated data, rather than real patient images. The document does not specify the sample size of simulated images or controlled experiments used for this bench testing.

Data Provenance: N/A (as no clinical test set was used). The testing was "bench testing."

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

N/A. Since the testing was bench testing and not a clinical study involving human readers or patient images, no experts were used to establish ground truth for a clinical test set.

4. Adjudication Method for the Test Set

N/A. As no clinical test set or human interpretation was involved, no adjudication method was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The document explicitly states: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence... Bench testing was sufficient..."

Therefore, there is no reported effect size of how much human readers improve with AI vs. without AI assistance.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done in the form of "bench testing." This testing evaluated the AutoGrid software's ability to achieve image contrast equivalent to a physical anti-scatter grid without human interpretation as part of the primary evaluation. The results of this bench testing were considered sufficient to demonstrate performance.

7. Type of Ground Truth Used

The ground truth for the bench testing was established by physical standards or measurements related to image contrast and scatter radiation reduction, likely derived from the performance characteristics of physical anti-scatter grids (e.g., 6:1, 8:1, 12:1 ratios). The benchmark was the "equivalent" image contrast produced by these physical grids.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning, nor does it specify a sample size for such a set. AutoGrid is described as "image processing software" and its mechanism is to "estimat[e] the scatter radiation within the image, and then subtract[] this scatter estimate from the image." While this could imply some form of algorithm trained on data, the submission focuses on its performance validation through bench testing against existing physical grid benchmarks, rather than detailing an AI/ML training process.

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

N/A. As no training set is explicitly mentioned or detailed, there is no information on how its ground truth might have been established.

Summary

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January 12, 2018

Image /page/0/Picture/1 description: The image shows 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 in blue. Underneath the FDA logo is the word "ADMINISTRATION".

GE Medical Systems, LLC % Mr. Chris Paulik Regulatory Affairs Program Manager 3000 N. Grandview Blvd. WAUKESHAWI 53188

Re: K173602

Trade/Device Name: Optima XR240amx with AutoGrid Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL, MQB Dated: November 20, 2017 Received: November 21, 2017

Dear Mr. Paulik:

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silv er Spring, MD 20993 w ww.fda.gov

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Section 4: Indications for Use (FORM FDA 3881)

Optima XR240amx with AutoGrid

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Indications for Use

510(k) Number (if known)

K173602

Device Name Optima XR240amx with AutoGrid

Indications for Use (Describe)

The system is indicated for taking radiographic exposures of the skull, spinal column, 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.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

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

DateSubmitted:	November 20, 2017
Submitter:	GE Medical Systems, LLC3000 N. Grandview BlvdWaukesha, WI 53188, USA
PrimaryContactPerson:	Chris PaulikRegulatory Affairs Program ManagerGE Healthcare262-548-2010Christopher.A.Paulik@ge.com
SecondaryContactPerson:	Diane UriellRegulatory Affairs DirectorGE Healthcare262-290-8218Diane.Uriell@ge.com
Device TradeName:	Optima XR240amx with AutoGrid
Common/UsualName:	Mobile X-ray system
Regulation,Classification,and ProductCode:	Regulation Name: Mobile X-Ray SystemRegulation: 21 CFR 892.1720Classification: Class IIProduct Codes: IZL, MQB

PredicateDevice(s):	Optima XR240amx (K162990)
	Regulation Name: Mobile X-Ray System
	Regulation: 21 CFR 892.1720
	Classification: Class II
	Product Codes: IZL, MQB
DeviceDescription:	The Optima XR240amx with AutoGrid is intended to take exposures,using a wired or remote exposure switch, utilizing film, computedradiography (CR), or cleared wireless radiographic detectors, which areintended to replace radiographic film screen systems in all generalpurpose diagnostic procedures, for digital radiography (DR).
	Optima XR240amx with AutoGrid is a self-contained; battery operatedmobile radiographic imaging system designed to generate diagnosticradiographic images (medical x-rays) that may increase the ability todetect disease or injury early enough for a medical problem to bemanaged, treated, or cured. Medical x-rays are used in many types ofexaminations and procedures, some examples include: x-rayradiography (to find orthopedic damage, tumors, pneumonias, foreignobjects).
	The Optima XR240amx with AutoGrid system is indicated for use onadult and pediatric patients for general-purpose diagnostic radiographicexaminations and procedures. Its mobility enables general-purposeradiographic procedures throughout the clinical environment, or asneeded within the emergency, intensive care, premature birth ward,cardiac and operating departments, for patients that may not be able tobe moved or in cases where it is unsafe or impractical to move them to atraditional RAD room.
	The incorporation of AutoGrid software into the Helix Image Processingsoftware on the Optima XR240amx allows the user to improve the imagecontrast in general radiographic images by reducing the effects ofscatter radiation in lieu of incorporating a physical anti-scatter grid ontothe cleared wireless detectors.
	The system is indicated for taking radiographic exposures of the skull,spinal column, chest, abdomen, extremities, and other body parts withthe patient sitting, standing, or lying in the prone or supine position.
	This device is not intended for mammographic applications.
Intended Use:	The Optima XR240amx is intended to take exposures utilizing film,computed radiography (CR), or wireless detectors, which are intended toreplace radiographic film screen systems in all general purposediagnostic procedures, for digital radiography (DR).
	Optima XR240amx is a self-contained; battery operated mobileradiographic imaging system designed to generate diagnosticradiographic images (medical x-rays) that may increase the ability todetect disease or injury early enough for a medical problem to bemanaged, treated, or cured. Medical x-rays are used in many types ofexaminations and procedures, some examples include: x-rayradiography (to find orthopedic damage, tumors, pneumonias, foreignobjects).
	The Optima XR240amx is indicated for use on adult and pediatricpatients for general-purpose diagnostic radiographic examinations andprocedures. Its mobility enables general-purpose radiographicprocedures throughout the clinical environment, or as needed within theemergency, intensive care, premature birth ward, cardiac and operatingdepartments, for patients that may not be able to be moved or in caseswhere it is unsafe or impractical to move them to a traditional RADroom.
	The system is indicated for taking radiographic exposures of the skull,spinal column, chest, abdomen, extremities, and other body parts withthe patient sitting, standing, or lying in the prone or supine position.
	This device is not intended for mammographic applications.
	The Optima XR240amx incorporates AutoGrid, which is an optionalimage processing software installed as a part of the systems Heliximage processing software. AutoGrid can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic imagesby reducing the effects of scatter radiation.
Technology:	The Optima XR240amx with AutoGrid employs the same fundamentalscientific technology as the predicate device. They are both batteryoperated mobile x-ray systems that capture exposures utilizing film, CRplates, or a wireless detector. The intended use is the same between theOptima XR240amx with AutoGrid and the predicate device. The OptimaXR240amx with AutoGrid did not change the input power, batterysubsystem, drive subsystem, x-ray generation, and exposure controlfrom the predicate devices. The difference being introduced is amodification to the Helix image processing software to incorporate anoptional image processing software called AutoGrid. AutoGrid can beused in lieu of a physical anti-scatter grid attached to the clearedwireless detectors to improve image contrast in general radiographicimages by reducing the effects of scatter radiation. The use of theAutoGrid software can improve user workflow since there is no need tophysically incorporate an anti-scatter grid into the image chain. Its usecan also alleviate issues caused by the incorrect Source to ImageDistance (SID) setup with physical anti-scatter grids, since the AutoGridsoftware does not require a specific SID to function.
The AutoGrid software reduces the effect of scatter radiation on theimage by estimating the scatter radiation within the image, and thensubtracting this scatter estimate from the image. The AutoGrid softwarecan be configured at three global strength options (Low, Medium, andHigh). The strength indicates the amount of scatter reduction that willoccur during image processing. The Low strength corresponds to theamount of scatter reduction that would occur through using a physical6:1 ratio grid, Medium a physical 8:1 ratio grid, and High a physical 12:1ratio grid. The AutoGrid software can be used in any application where aphysical grid was originally indicated, including both adult and pediatricimaging techniques or protocols.The AutoGrid software is an optional feature that cannot be used inconjunction with a physical grid.
Determinationof SubstantialEquivalence:	Summary of Non-Clinical Tests:
	The modification to the Optima XR240amx to include AutoGrid and itsapplications comply with voluntary standards:
	ES60601-1 Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance ; IEC 60601-1-3 Medical Elec. Equipment - P. 1: General Req. for Safety3. Collateral Standard: General Req. for Radiation Protection inDiagnostic XRay Equipment; IEC 60601-1-6 Medical electrical equipment - Part 1-6: Generalrequirements for safety - Collateral Standard: Usability ; IEC 60601-2-54 Medical electrical equipment - Part 2- 54: Particularrequirements for the basic safety and essential performance of X-rayequipment for radiography and radioscopy ; IEC 62366 Medical devices - Application of usability engineering tomedical Devices; PS 3.1 - 3.20 Digital Imaging and Communications in Medicine(DICOM) set. (Radiology).
	The following quality assurance measures were applied to thedevelopment of the 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 AutoGrid software intothe Helix Image Processing software of the Optima XR240amx. Theserisks were reviewed and mitigated with design controls and labeling.The mitigations were verified and validated as a part of the designverification and validation testing that has been executed withacceptable results.
Summary of Clinical Tests:
The subject of this premarket submission, Optima XR240amx withAutoGrid, did not require clinical studies to support substantialequivalence of using the AutoGrid software in lieu of a physical anti-scatter grid. Bench testing was sufficient to demonstrate that theAutoGrid software can achieve image contrast equivalent to that of aphysical anti-scatter grid. The results of the bench testing are provided inthe submission.
Design verification and validation testing was performed to confirm thatthe safety and effectiveness of the device has not been affected. Thetest plans and results have been executed with acceptable results.
Conclusion:	The AutoGrid software that is incorporated into the Helix ImageProcessing software of the Optima XR240amx can be used in lieu of aphysical anti-scatter grid attached to the cleared wireless detectors toimprove image contrast in general radiographic images by reducing theeffects of scatter radiation. This update to this system does not result inany new potential safety risks, it has the same technologicalcharacteristics, and perform as well as the devices currently on themarket.
	After analyzing design verification and validation testing on the bench itis the conclusion of GE Healthcare that the Optima XR240amx withAutoGrid to be as safe, as effective, and performance is substantiallyequivalent 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.