The DRX-Revolution Nano Mobile X-ray System (also referred to as the DRX-Revolution Nano) is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. The system consists of a self contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of a standard stationary x-ray room. The DRX-Revolution Nano system can also be used to expose CR storage phosphor screen or film cassettes.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

Overall Assessment: The provided document is a 510(k) premarket notification for the DRX-Revolution Nano Mobile X-ray System. It describes the device, its intended use, comparison to a predicate device, and performance testing. The clinical study mentioned is a comparative effectiveness study designed to show non-inferiority to the predicate device, not a standalone study demonstrating specific performance metrics against a defined acceptance criterion. The key takeaway is that the diagnostic capability of the new device is statistically equivalent to or better than the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the diagnostic performance of the DRX-Revolution Nano itself, nor does it list specific performance metrics like sensitivity or specificity. Instead, the "acceptance criterion" for the clinical study was to demonstrate statistical equivalence or superiority in diagnostic capability compared to the predicate device.

Acceptance Criterion (for Clinical Study)	Reported Device Performance
Diagnostic capability (of investigational device vs. predicate device)	Statistically equivalent to or better than the predicate device.
Compliance with general safety and regulatory standards (non-clinical testing)	Predefined acceptance criteria were met. Device conforms to specifications.

Note: The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific quantitative diagnostic performance thresholds as might be defined for a novel AI algorithm.

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

Sample Size for Test Set:
- Clinical Study: "Adult cadavers were used to perform pair-wise investigational vs. predicate acquisitions using similar radiographic techniques and body positioning for 2D imaging."
  - The specific number of adult cadavers is not provided.
  - The images included targeting various exam types such as chest, abdomen, skull, C-spine, L-spine, pelvis, hip, nasal bones, shoulder, and extremity radiographs.
- Pediatric Phantom Images: "In addition, eight pediatric phantom images were acquired on both the investigational and predicate devices in the laboratory at Carestream Health, Inc."
  - This suggests 8 unique pediatric phantom images were taken with both devices, resulting in 16 total images from phantoms.
Data Provenance:
- Adult Cadaver Images: Not explicitly stated, but implies the studies were conducted by Carestream Health. Not specified if retrospective or prospective, but likely acquired prospectively for the study.
- Pediatric Phantom Images: Acquired in the laboratory at Carestream Health, Inc. (Prospective).

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

The document mentions a "Reader Study" but does not specify the number or qualifications of the experts/readers who established the (presumably diagnostic) ground truth for the test set.

4. Adjudication Method for the Test Set

The document states: "The images were assembled and reviewed in a single stimulus random format in order to perform a Comparative Evaluation to statistically confirm the findings of this evaluation."

This describes the presentation format to the readers but does not specify an adjudication method for establishing a consensus ground truth (e.g., 2+1, 3+1). It implies readers were evaluating images against each other (investigational vs. predicate) rather than against an independently established ground truth.

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

MRMC Comparative Effectiveness Study: Yes, a comparative study was performed between the DRX-Revolution Nano (investigational) and the DRX-Revolution Mobile X-ray System (predicate). The images were reviewed by readers (implied by "Reader Study").
Effect Size of Human Readers with AI vs. Without AI Assistance: This question is not applicable here. The DRX-Revolution Nano is an X-ray imaging system, not an AI-powered diagnostic algorithm designed to assist human readers. The study compares the imaging performance of two different X-ray systems.

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

This question is not applicable. The device is a mobile X-ray system, not a standalone algorithm. The clinical study evaluated the imaging performance and diagnostic capability of the system in producing images that radiologists would interpret, not an algorithm's performance independent of human interpretation.

7. The Type of Ground Truth Used

The document does not explicitly state the specific type of ground truth used (e.g., pathology, clinical outcomes, expert consensus) for the diagnostic capabilities evaluated in the reader study. It implies that the "diagnostic capability" was assessed by human readers comparing "investigational vs. predicate acquisitions." It's likely that the readers' interpretations, potentially against a "reference standard" if established per case, formed the basis, but this is not detailed.

8. The Sample Size for the Training Set

This question is not applicable. The DRX-Revolution Nano is a hardware X-ray system with embedded software for image acquisition and processing. It is not described as an AI/ML algorithm that requires a "training set" for diagnostic decision-making. The software verification and validation section indicates testing was done on the embedded software for its functionality and safety, not for a learning model.

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

This question is not applicable for the same reasons as point 8.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

Carestream Health, Inc. Victoria Wheeler Seinor Regulatory Affairs Manager, Regulatory & Quality Systems 150 Verona Street Rochester, New York 14608

June 21, 2017

Re: K170755

Trade/Device Name: DRX-Revolution Nano Mobile X-ray System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL Dated: May 26, 2017 Received: May 30, 2017

Dear Ms. Victoria Wheeler:

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

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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.

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/ResourcesforYou/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,

Michael D. O'Hara
For

Robert A. 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

510(k) Number (if known) K170755

Device Name

DRX-Revolution Nano Mobile X-ray System

Indications for Use (Describe)

The device is designed to perform radiographic x-ray examinations on 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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Carestream

"510(k) Summary"

510(k) Owner Name:510(k) Owner Address:	Carestream Health, Inc.150 Verona StreetRochester, New York 14608
510(k) Owner Phone:510(k) Owner Fax:	585-627-8706585-627-8802
Contact Person & Info:	Victoria WheelerSenior Regulatory Affairs Managervictoria.wheeler@carestream.com585-627-8706
Date Summary Prepared:	May 26, 2017
Device Trade Name:Device Common Name:Classification Name:	DRX-Revolution Nano Mobile X-ray SystemMobile x-ray systemMobile x-ray system
Device Class:Device Code:Regulation Number:	Class IIIZL21 CFR 892.1720
Predicate Device:	DRX- Revolution Mobile X-ray SystemManufactured by: Carestream Health, Inc.510(k) No.: K120062 (April 13, 2012)Classification Regulation: 21 CFR 892.1720Classification Name: Mobile x-ray systemPrimary Product Code: IZL

Device Description:

Device Description

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The DRX-Revolution Nano system is designed to be used with the following legally marketed solid state imaging devices (referred to throughout this document as "detectors"):

Carestream DRX-1 Detector (K090318); o
Carestream DRX-1C Detector (K120062)
DRX Plus 3543 Detector and DRX Plus 3543C Detector (K150766) ●
DRX Plus 4343 Detector and DRX Plus 4343C Detector (K153142) ●
DRX Core 3543 Detector (Relabeled version of the DRX Plus 3543 Detector) ●
DRX Core 3543C Detector (Relabeled version of DRX Plus 3543C Detector) ●
. DRX Core 4343 Detector (Relabeled version of the DRX Plus 4343 Detector)
DRX Core 4343C Detector (Relabeled version of the DRX Plus 4343C Detector ●
DRX 2530C Detector (K130464) ●

These detectors are commercially available for use with other Carestream products or as standalone devices. Image acquisition software for the detectors is integrated with the mobile x-ray system's user interface.

The DRX-Revolution Nano contains several wireless components that facilitate its use. Specifically, the Carestream detectors communicate to the console wirelessly, eliminating the need for cables that can hinder efficient workflow. The detector is also capable of communicating to the console via a wired ("tethered") connection if desired. Other peripheral wireless components include a badge reader for employee sign-in, an optional 2D barcode reader (for patient ID), and wireless communication capability with the hospital network.

Indications for Use

The Indications for Use for the device, as described in its labeling, are: «The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas."

Intended Use

The intended use for this device, as determined by descriptions and the proposed labeling contained in this submission, is similar to the Indications for Use statement provided above. The DRX-Revolution Nano is a mobile system used to generate and control x-rays for diagnostic procedures. We believe that the DRX-Revolution Nano and the predicate device have the same intended use.

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Comparison of Technological Characteristics:

Based upon information provided within this submission, we believe that the DRX-Revolution Nano Mobile X-ray System is substantially equivalent to the legally marketed DRX-Revolution Mobile X-ray System. At a high level, the subject device and predicate devices are based on the same technological elements as listed below:

X-ray generator ●
X-ray tube ●
Collimator
Graphical user interface ●
Operator console with Touchscreen Display ●
Battery powered mobile cart ●
Flat panel detector and o
System software with image processing capability ●
Optional IR remote o

The following technological characteristics in the subject device are different from those of the predicate device:

Stationary anode X-ray tube
Lower powered generator
Collimator has lower projection radiography range ●
Elimination of auxiliary Touchscreen Display on the tube head ●
Use of different battery technology
o Smaller sized cart
Manually driven ●
Use of articulating arm with increased rotation o

The DRX-Revolution Nano Mobile X-ray System (Nano) and the DRX-Revolution Mobile X-ray System both consist of an x-ray generator, x-ray tube, collimator, optional Infrared remote and graphical user interface on an operator console with touch screen monitor. These components are mounted on a mobile cart to enable the device to be moved from location to location. Both systems utilize a digital flat panel detector for image capture and can also be used to expose CR storage phosphor screen or film cassettes. Both systems have an operator console with the same image processing software. The Intended Use is the same for both devices.

Both systems have operator console software that is based on the DirectView platform, but specific user interface screens and software components are specific to the DRX-Revolution Nano device. These screens were developed to control and manage the DRX-Revolution Nano's hardware subsystems including its X-ray generator. All of the embedded software and subsystem firmware of the DRX-Revolution Nano was developed specifically for the new (Nano) hardware system.

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The DRX-Revolution Nano offers hardware features (such as an articulating arm) that are different from the predicate device. These features are designed to aid the user in achieving an efficient workflow but do not result in additional indications for use (i.e., there is no change to the intended diagnostic effect) for the new device as compared to the predicate.

Performance Testing:

The DRX-Revolution Nano conforms to the following standards:

ISO 14971:2012 Medical device application of risk management to medical device ●
Digital Imaging and Communication in Medicine (DICOM)
0 IEC 60601-1-2 Edition 3: Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance
IEC 60601-2-54: Medical electrical equipment Part 2-54: Particular requirements ● for the basic safety and essential performance of X-ray equipment for radiography and radioscopy.

Discussion of Testing

The performance characteristics and operation / usability of the DRX-Revolution Nano Mobile X-ray System were evaluated in non-clinical (bench) testing. These studies have demonstrated the intended workflow, related performance, overall function, shipping performance, verification and validation of requirements for intended use, and reliability of the system including both software and hardware requirements. Non-clinical test results have demonstrated that the device conforms to its specifications. Predefined acceptance criteria were met and test results havedemonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device.

The following performance data were provided in support of the substantial equivalence determination:

Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the DRX-Revolution Nano Mobile X-ray System in compliance to IEC 60601-1-2:2007 – Medical electrical equipment Part 1-2, Electromagnetic Compatibility.

● Software Verification and Validation Testing

Software verification and validation testing was conducted and documentation has been provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in

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Medical Devices." The software for this device is considered to present a "moderate" level of concern. This is based on the fact that a malfunction of or latent design flaw in the software component could lead to an erroneous diagnosis, or to a delay in delivery of appropriate medical care that may lead to a minor injury.

Clinical Studies

A Clinical Study was performed to investigate the imaging performance of the DRX-Revolution Nano Mobile X-ray System ((investigational device) as compared to the currently marketed DRX-Revolution Mobile X-ray System (K120062), (predicate device). Both devices were paired with the DRX Plus 3543 detector (K150766) for execution of the clinical study.

As compared to the predicate device, the DRX-Revolution Nano is a smaller, manually driven and operated mobile x-ray system. The Nano has a collapsible arm assembly that pivots rather than the predicate's telescoping column. The image acquisition module and image processing software are unchanged from the predicate. The DRX-Revolution Nano can interface with various Carestream digital detectors including the DRX 2530C, DRX-1, DRX Plus, and DRX Core detectors, as can the predicate.

Adult cadavers were used to perform pair-wise investigational vs. predicate acquisitions using similar radiographic techniques and body positioning for 2D imaging. The images acquired included targeting various exam types such as the chest, abdomen, skull, C-Spine, L-Spine, pelvis, hip, nasal bones, shoulder, and extremity radiographs. In addition, eight pediatric phantom images were acquired on both the investigational and predicate devices in the laboratory at Carestream Health, Inc. The images were assembled and reviewed in a single stimulus random format in order to perform a Comparative Evaluation to statistically confirm the findings of this evaluation.

Results of the Reader Study demonstrated that the diagnostic capability of the DRX-Revolution Nano Mobile X-ray System is statistically equivalent to or better than that of the predicate device.

Conclusions

Since the predicate device was cleared based in part on the results of clinical studies, clinical testing was required to support substantial equivalence in terms of diagnostic capability. Non-clinical test results support the safety and effectiveness of the device and demonstrate that the DRX-Revolution Nano Mobile X-ray System performs as intended in the specified conditions. Results of both non-clinical and clinical tests demonstrate that the DRX-Revolution Nano Mobile X-ray System is as safe and as effective as the predicate device that is currently marketed for the same intended use.

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.