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.

Device Description

The Optima XR240amx 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 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 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 cleared flat panel detectors provides increased functionality to enable images of patients of all sizes, and can produce comparable quality images with as little as half the dose of traditional computer radiography (CR), cassettes and other flat panel detectors with lower DQE.

The systems are 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.

These devices are not intended for mammographic applications.

AI/ML Overview

The provided text describes the GE Healthcare Optima XR240amx mobile x-ray system and its substantial equivalence to predicate devices. It focuses on the changes introduced by incorporating cleared wireless detectors with WiFi communication.

Here's an analysis of the acceptance criteria and study information provided:

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

The document does not explicitly present a table of acceptance criteria with specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic task for the Optima XR240amx itself, as the device is an imaging system rather than a diagnostic algorithm.

Instead, the acceptance criteria are implicitly related to demonstrating that the modifications (incorporation of WiFi-enabled detectors) do not negatively impact the safety and effectiveness of the device and that its performance is substantially equivalent to the predicate devices. The reported "performance" focuses on compliance with standards and successful verification and validation of changes.

Acceptance Criteria (Implied)	Reported Device Performance
Maintain Safety	Risk analysis, design controls, and labeling used to mitigate new risks from wireless image transfer. Mitigations verified and validated with acceptable results.
Maintain Effectiveness	Design verification and validation testing performed to confirm safety and effectiveness have not been affected. Test plans and results executed with acceptable results.
Substantial Equivalence to Predicate Devices	Uses same fundamental scientific technology (battery-operated mobile x-ray system). Same intended use and indications for use. Changes confined to wireless communication hardware (UWB to WiFi) and software/firmware to support new detectors. Performance "as good as," "as safe as," and "as effective as" predicate devices.
Compliance with Voluntary Standards	The device and its applications comply with voluntary standards.
Image Quality	The incorporation of cleared flat panel detectors can "produce comparable quality images with as little as half the dose of traditional computer radiography (CR), cassettes and other flat panel detectors with lower DQE." (This is a general performance characteristic of the detectors, not a specific criterion for the Optima XR240amx's modifications).

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

The document states: "The subject of this premarket submission, Optima XR240amx, did not require clinical studies to support substantial equivalence for the incorporation WiFi (802.11) enabled detectors due to these detectors having their own 510(k) clearance."

Therefore, there isn't a "test set" in the traditional sense of a clinical trial with patient data. The testing mentioned in the document is primarily design verification and validation testing on the bench, not clinical data evaluation. The "data" provenance for these tests would be internal engineering tests.

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

Not applicable. As noted above, there was no clinical study with a patient test set requiring expert interpretation for ground truth establishment.

4. Adjudication method for the test set

Not applicable. No clinical test set.

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 device is a mobile x-ray system, not an AI or CAD (Computer-Aided Detection) device that assists human readers. Therefore, an MRMC study and analysis of AI assistance effect size are not relevant to this submission.

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

Not applicable. This is not an algorithm-only device. It is a hardware system for acquiring x-ray images.

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

Not applicable for clinical ground truth. The "ground truth" for the verification and validation tests would be defined by engineering specifications and expected system behavior, tested against established standards and successful operation.

8. The sample size for the training set

Not applicable. As this device is a hardware imaging system, there is no "training set" in the context of machine learning algorithms.

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

Not applicable. No training set for a machine learning algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the Optima XR240amx meets acceptance criteria primarily consisted of non-clinical design verification and validation testing.

Rationale for non-clinical studies: The submission argued that clinical studies were not required because the changes were limited to wireless communication hardware and associated software to accommodate already cleared detectors (PerkinElmer, Inc. XRpad2 3025 HWC-M and XRpad2 4336 HWC-M Flat Panel Detectors, cleared under K161942 and K161966 respectively). The core imaging technology and intended use remained the same as the predicate devices (Optima XR200amx and Optima XR220amx, K142383).
Verification and Validation Activities: GE Healthcare performed the following quality assurance measures:
- Risk Analysis (new risks from wireless image transfer were identified, mitigated with design controls and labeling, and verified/validated).
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
- Simulated use testing (Validation)
Conclusion: The results of these design verification and validation tests were deemed "acceptable," leading GE Healthcare to conclude that the Optima XR240amx is as safe, effective, and substantially equivalent in performance to the predicate devices. The device's update "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."

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 15, 2016

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

Re: K162990

Trade/Device Name: Optima XR240amx Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL, MQB Dated: October 26, 2016 Received: October 27, 2016

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'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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Indications for Use (FORM FDA 3881) Section 4:

Optima XR240amx

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Indications for Use

510(k) Number (if known)

K162990

Device Name Optima XR240amx

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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(k) Summary

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

Date:	October 26, 2016
Submitter:	GE Medical Systems, LLC
	3000 N. Grandview Blvd
	Waukesha, WI 53188, USA
PrimaryContactPerson:	Chris Paulik
	Regulatory Affairs Program Manager
	GE Healthcare
	262-548-2010
	Christopher.A.Paulik@ge.com
SecondaryContactPerson:	Diane Uriell
	Regulatory Affairs Director
	GE Healthcare
	262-290-8218
	Diane.Uriell@ge.com
Device TradeName:	Optima XR240amx
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 XR200amx and Optima XR220amx (K142383)
	Regulation Name: Mobile X-Ray System
	Regulation: 21 CFR 892.1720
	Classification: Class II
	Product Codes: IZL, MQB
DeviceDescription:	The Optima XR240amx is intended to take exposures, using a wired orremote exposure switch, utilizing film, computed radiography (CR), orcleared wireless radiographic detectors, which are intended to replaceradiographic film screen systems in all general purpose diagnosticprocedures, 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 system 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 incorporation of cleared flat panel detectors provides increasedfunctionality to enable images of patients of all sizes, and can producecomparable quality images with as little as half the dose of traditionalcomputer radiography (CR), cassettes and other flat panel detectors withlower DQE.
	The systems are 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.
	These devices are 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.
Technology: The Optima XR240amx employs the same fundamental scientifictechnology as the predicate devices. They are both battery operatedmobile x-ray systems that capture exposures utilizing film, CR plates, ora wireless detector. The intended use and the indications for use are thesame between the Optima XR240amx and the predicate devices. TheOptima XR240amx did not change the input power, battery subsystem,drive subsystem, x-ray generation, and exposure control from thepredicate devices. The difference being introduced with the OptimaXR240amx is that exposures can be captured with cleared detectors ofmultiple sizes. These cleared detectors utilize WiFi (802.11) instead ofUltra Wideband (UWB) technology to transfer the image to the basesystem. To accommodate the cleared wireless detectors, the OptimaXR240amx changed the following from the predicate devices:Wireless communication hardware for detector communication was changed from UWB to WiFi (802.11) Detector storage bin geometry and its associated detector charging hardware and firmware to accommodate multiple sized cleared wireless detectors (17 inch x 14 inch; 10 inch x 12 inch) System software to accomplish the following: WiFi (802.11) association and pairing with the cleared wireless detectors Synchronizing the image acquisition and image retrieval from the cleared wireless detectors Image processing algorithms to accommodate multiple image matrix sizes User interface updates for image acquisition to incorporate the cleared wireless detectors into the user workflow

Determinationof SubstantialEquivalence:	Summary of Non-Clinical Tests:
	The Optima XR240amx and its applications comply with voluntarystandards. The following quality assurance measures were applied tothe development 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 wireless image transferbetween the cleared wireless detector and the base system. These riskswere reviewed and mitigated with design controls and labeling. Themitigations 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, did notrequire clinical studies to support substantial equivalence for theincorporation WiFi (802.11) enabled detectors due to these detectorshaving their own 510(k) clearance. The detectors used to verify andvalidate the Optima XR240amx were the PerkinElmer, Inc. XRpad2 3025HWC-M Flat Panel Detector cleared under K161942 and the PerkinElmer,Inc. XRpad2 4336 HWC-M Flat Panel Detector cleared under K161966.
	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 Optima XR240amx device incorporates cleared radiographicdetectors to capture radiographic images and utilizes a tether orwireless technology to transfer the images to the base system. Thisupdate to this system does not result in any new potential safety risks, ithas the same technological characteristics, and perform as well as thedevices currently on the market.
	After analyzing design verification and validation testing on the bench itis the conclusion of GE Healthcare that the Optima XR240amx to be assafe, as effective, and performance is substantially equivalent to thepredicate devices.

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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.