The DRX-Revolution Mobile X-ray System is a mobile diagnostic x-ray system that utilizes digital technology for bedside or portable exams. Key components of the system are the x-ray generator, a tube head assembly (includes the x-ray tube and collimator) that allows for multiple axes of movement, a maneuverable drive system, touchscreen user interface(s) for user input. The system is designed with installable software for acquiring and processing medical diagnostic images outside of a standard stationary X-ray room. It is a mobile diagnostic system intended to generate and control X-rays for examination of various anatomical regions.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the DRX-Revolution Mobile X-ray System, which includes changes such as the addition of Smart Noise Cancellation (SNC) functionality and compatibility with a new detector (Lux 35). The study focuses on demonstrating the substantial equivalence of the modified device to a previously cleared predicate device (DRX-Revolution Mobile X-ray System, K191025).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided information:

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

Acceptance Criteria (for SNC)	Reported Device Performance
At least 99% of all image pixels were within ± 1 pixel value	Achieved. The results demonstrated that at least 99% of all image pixels were within ± 1 pixel value.
Absolute maximum difference across all test images should be ≤ 10-pixel values	Achieved. The absolute maximum difference seen across all test images was 3-pixel values, meeting the acceptance criterion of a maximum allowable difference of 10-pixel values.
Noise ratio values computed for every pixel of the test images should be < 1.0	Achieved. All noise ratio values computed for every pixel of the test images were less than 1.0, indicating that the difference in SNC noise fields between the Evolution and Revolution systems was less than the expected system noise.
No perceptible differences visually when compared at 200% magnification using flicker comparison	Achieved. Processed images on both systems were visually compared on a diagnostic monitor using flicker comparison, and no perceptible differences were observed when compared at 200% magnification.

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

Test Set Sample Size: Not explicitly stated as a number of images or patients. The study refers to "all the test images" for pixel difference analysis and "every pixel of the test images" for noise ratio calculations, implying a comprehensive evaluation of the images used.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It mentions comparing images from the "in-room system (K202441)" which is the DRX-Evolution Plus system, suggesting a controlled comparison under laboratory or simulated clinical conditions rather than real-world patient data.

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

This type of information is generally relevant for studies involving human interpretation and clinical endpoints. For the technical performance evaluation of Smart Noise Cancellation (SNC) described, the "ground truth" was established through quantitative technical metrics (pixel value differences, noise ratios) and visual comparison, rather than human expert consensus on clinical diagnoses. Therefore, no human experts were explicitly used to establish ground truth in the traditional sense for this specific performance evaluation.

4. Adjudication method for the test set

Given that the performance evaluation was based on quantitative pixel-level analysis and visual comparison by presumably trained personnel rather than clinical interpretation, an adjudication method (like 2+1 or 3+1) was not applicable or described.

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

No MRMC comparative effectiveness study was done or described. The study focused on the technical equivalency of the SNC feature between two systems (mobile vs. in-room) and the integration of new hardware (detector), not on the impact of AI assistance on human reader performance.

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

Yes, a standalone performance evaluation of the SNC algorithm and its image output was effectively done. The assessment involved a "pixel-by-pixel analysis" and "noise ratio metric" to compare the output of the SNC processing on the mobile system against the in-room system. This evaluated the algorithm's performance independently of human interpretation.

7. The type of ground truth used

The ground truth for the SNC performance evaluation was established through quantitative technical metrics and visual comparison against a known reference (the in-room system's SNC output). The reference was the cleared in-room system (DRX-Evolution Plus, K202441) with SNC, which was considered the "expected" or "gold standard" performance for SNC.

8. The sample size for the training set

The document does not provide information on the sample size for the training set. This submission is for a modification to an existing device, specifically integrating an already cleared SNC technology (from K202441) onto a mobile platform and adding a new detector. The focus is on demonstrating the equivalence of the implementations and not on the development or training of the SNC algorithm itself.

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

Since information on the training set for the SNC algorithm is not provided, how its ground truth was established is not detailed in this document. It's implied that the SNC algorithm itself was developed and validated in the predicate device (DRX-Evolution Plus, K202441) submission, and the current submission leverages that existing, cleared technology.

Summary

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December 10, 2024

Carestream Health Inc. % Gina Maiolo Sr. Regulatory Affairs Manager 150 Verona St. ROCHESTER, NY 14608

Re: K241505

Trade/Device Name: DRX-Revolution Mobile X-ray System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: November 12, 2024 Received: November 12, 2024

Dear Gina Maiolo:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K241505

Device Name

DRX-Revolution Mobile X-ray System

Indications for Use (Describe)

"The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas."

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

K241505

510(k) Owner Name

Carestream Health, Inc.

510(k) Owner Address 150 Verona Street Rochester, New York 14608 510(k) Owner Contact Information Gina Maiolo Regulatory Affairs Manager Phone (Mobile) 516.395.0597 Date Summary Prepared October 28 2024 Device Trade Name DRX-Revolution Mobile X-Ray System Device Common Name Mobile System Classification Name Mobile X-ray system Device Class Class II Device Code IZL Regulation Number 21 CFR 892.1720. Predicate Device DRX-Revolution Mobile X-Ray System (K191025)

Carestream Health, Inc. is submitting this Traditional 510(k) premarket notifications to the DRX-Revolution System. Carestream believes that the modified device is substantially equivalent to the cleared device (K191025).

Indications for Use

"The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas".

Device Description

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Technological Characteristics

The modified DRX-Revolution Mobile X-ray system is substantially equivalent to the predicate device currently cleared on the market (K191025).

The modified DRX-Revolution consists of the same fundamental scientific technology and is . designed with the same operating principles as the predicate device. The predicate and modified device consist of the same critical components: an x-ray generator, x-ray tube, collimator, and image acquisition software (ImageView) to support image / patient management.
. The digital radiography application software has been cleared for use across the following Carestream digital radiography devices: DRX-Evolution System (K163203), DRX-Compass System (K223842), DRX-Revolution (K191025).
. The ImageView software is the same image acquisition software installed on the predicate device (K191025). Eclipse II, the image processing software (designed into ImageView) and the imaging processing components cleared on the predicate device are the same on the modified device. The predicate was cleared with ImageView V1.0 and the modified device will run ImageView V2.0. The difference in versions do not raise additional question on safety or performance. The below key functionality offered in V2.0 is the same on the cleared device.
- · Configuration of operational parameters
- · Patient creation
- · Patient worklist
- · Status Display (acquisition, delivery, errors, etc.)
- · X-Ray Generator operation
- · Image acquisition
- · Image review
- · Communication to external HIS, RIS, PACS, and printers
The modified DRX-Revolution system is compatible with the following legally marketed Carestream detectors (same detectors cleared with the predicate device): DRX Plus 3543C (K150766), DRX Plus 4343C (K153142), DRX Plus 2530C (K183245).
. The Lux 35 detector is an additional detector that will be available for sale with the DRX-Revolution. Lux 35 was cleared (K203159) in a separate submission and is determined substantially equivalent to the DRX Plus detectors as the MTF/DQE data demonstrates.
. Smart Noise Cancellation (SNC) on the mobile x-ray system produces the same image output as the in-room x-ray system (with SNC). Comparison testing was performed and demonstrates imaging output and performance on the mobile system is the same as it is on the in-room system.

Comparison of Technological Characteristics

A comparison chart provides the similarities and differences between the modified and predicate devices.

	Predicate Device	Subject Device	Comments
Device Name	DRX-Revolution Mobile X-ray System	DRX-Revolution MobileX-ray System
510(k) Number	K191025	K241505
Device ClassificationName	Mobile X-ray System	Mobile X-ray System
Intended Use	The device is designed toperform radiographic x-rayexaminations on all pediatricand adult patients, in allpatient treatment areas.	Same	No impact
X-ray GeneratorModel/Rating	Carestream Generator (32kW)	Same	No impact
X-ray TubeManufacture/Model	Toshiba/XRR-3336X	Same	No impact
Image ProcessingSoftware	Eclipse II	Same	No impact
DR Application SystemSoftware	ImageView Software	Same	No impact
Smart NoiseCancellation (SNC)	No	Yes	SNC is cleared with a stationaryx-ray system (DRX Evolution -K202441). SNC functions thesame on the DRX-Revolutionsystem (mobile) as it does onthe DRX-Evolution (in-room)system.Comparison testing shows SNCimage output is the same on themobile system as it is on thecleared in-room system(K202441).Supplemental data demonstratesthe testing for Smart NoiseCancellation (SNC) on theDRX-Revolution (mobilesystem) is comprehensive andthe functionality was adequatelytested.
Digital Flat PanelDetectors	DRX Plus 3543C, 4343C(K153142)DRX Plus 2530C (K183245)	SameLux 35 Detector(K203159)	Lux 35 obtained clearance in aseparate submission K203159.Addition of a detector has noimpact on image quality or onthe imaging system. Lux 35 issubstantially equivalent to theDRX Plus detectors.System integration testing wasperformed to support integrationof the compatible detectors withthe DRX-Revolution systemusing ImageView Softwarev2.0.
Align Assist	No	Yes	Improvement to optimizeworkflow operation.
Inching	No	Yes	Additional option for movementof the cart.
			Verification and validationtesting of both hardware andsoftware were completed todemonstrate safety andperformance.
Cumulative Changes	Yes	Yes	Design improvements tocomponents (component-levelfunctionality same on predicate)• Generator components• Tube head handles• Tube head covers• Cord Reel

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Carestream

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Summary of Non-Clinical Testing

Clinical testing was not required to establish substantial equivalence. Performance testing was sufficient to assess the device safety and effectiveness and to demonstrate that the modified device is substantially equivalent to the cleared device.

Comparison testing was performed to demonstrate SNC image output is the same on the mobile system as it is on the in-room system (K202441). A pixel-by-pixel analysis was used to determine whether the SNC processing performed on the DRX-Revolution Mobile X-ray system is considered equivalent to the SNC processing performed on the DRX-Evolution Plus system. The processed images on both systems were visually compared on a diagnostic monitor using flicker comparison (fast switching of registered images to detect small differences) and no perceptible differences were observed when compared at 200% magnification. The results of the SNC images demonstrated that at least 99% of all image pixels were within ± 1 pixel value. All pixels in the output image must be within +/-1 pixel value and the absolute maximum difference seen across all the test images was 3-pixel values, thus meeting the acceptance criteria of a maximum allowable difference of 10-pixel values.

Additionally, a noise ratio metric was created to compare the SNC noise field difference with the expected system noise variation. All noise ratio values computed for every pixel of the test images were less than 1.0 indicating that the difference in SNC noise fields between the Evolution and Revolution systems was less than the expected system noise, further supporting the conclusion that the SNC image differences on the mobile system are undetectable.

The following consensus standards were met:

ISO 14971:2019 Application of risk management to medical devices
ISO 20471:2021 Medical devices - Information to be supplied by the manufacturer
IEC 62366-1:2015+A1:2020 Medical devices - Part 1: Application of usability engineering to medical devices
. ISO 15223-1:2021 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
. AAMI ES60601-1:2005 +C1:A2: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012)
IEC 60601-1-2:2015 Electro-Magnetic Compatibility including FCC Part 15 Subpart B:2018
. IEC 60601-1-3:2008+A2:2021 (Second Edition) + A1:2013 Medical electrical equipment - Part 1-3: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment
. IEC 60601-1-6:2010 + A1:2015, Edition 3.0 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard
. IEC 60601-2-54:2009+A1:2015 Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
. 60601-2-28:2017 Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
. IEC 62304:2006 + A1:2015 Medical device software life-cycle processes
ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a . risk management process
Digital Imaging and Communication in Medicine (DICOM) .

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.