The Rover product concept was developed under a contract from the Australian Department of Defense to fulfil a need for a full performance digital medical x-ray imager, light enough to be used in deployed medical facilities. Key Design Features:

Full trauma imaging capability 40-110kV, 0.2-20mAs;
Ultra-light weight at 105 kg;
Ground Clearance allows for 75mm step up;
Operation on uneven ground;
Spare battery tray swap out in under a minute;
The unit uses FDA cleared digital image capture panels and software made by FujiFilm.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the "Rover" mobile x-ray system. It details the device's technical specifications and compares it to a legally marketed predicate device (DRX-Revolution Nano Mobile X-ray System). The acceptance criteria and testing described are focused on demonstrating substantial equivalence to an existing device, rather than proving performance against specific acceptance criteria for an AI/ML-based device.

Therefore, the document does not contain the information requested regarding acceptance criteria related to AI/ML device performance, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance.

Here's why the document doesn't provide the requested information and what it does provide:

Device Type: The Rover is a mobile x-ray system, a physical medical device for capturing x-ray images. It uses FDA-cleared digital image capture panels and software (specifically, Fujifilm and Fuji FDX Console Advance DR-ID 300CL Software) which are themselves "previously cleared." This submission is about the system integrating these components, not about a novel AI/ML algorithm for image analysis or diagnosis.
Basis for Clearance: The basis for clearance is "substantial equivalence" to a predicate device, focusing on functional, technical, and safety equivalence of the hardware and integrated pre-cleared software.
Testing: The testing detailed is primarily non-clinical bench testing to confirm proper system operation and safety standards compliance (e.g., IEC standards, radiation performance, cybersecurity, wireless technology).
Clinical Testing: The document explicitly states: "Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance." This means no new clinical data (and thus no associated ground truth, expert reads, or AI performance metrics) was generated for this specific 510(k) submission.

Summary of what is present in the document that somewhat relates to the request, but not in the context of AI/ML acceptance criteria:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit): Substantial equivalence to the predicate device in terms of indications for use, configuration, generator specifications, panel interfaces, and meeting US performance standards (21 CFR 1020.30 and 21 CFR 1020.31). Also, compliance with various IEC standards (60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-28, 60601-2-54).
- Reported Device Performance: The "Substantial Equivalence Chart" (page 5) compares the Rover to the predicate, showing "SAME" or "Equivalent" for most characteristics. "Bench testing indicate that the new devices are as safe and effective as the predicate devices. Proper system operation is fully verified upon installation. We verified that the modified combination of components worked properly and produced diagnostic quality images as good as our predicate generator/panel combination." (page 6)
Sample sized used for the test set and the data provenance: Not applicable in the context of AI/ML performance testing. Testing was system-level functional and safety verification.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for image interpretation was not established as part of this submission. The software components were previously cleared.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, as this is a mobile x-ray system, not a standalone AI algorithm. The imaging software used is a pre-cleared component.
The type of ground truth used: Not applicable for AI/ML performance. The "ground truth" for the device's acceptable performance was its compliance with safety standards and its ability to produce diagnostic quality images comparable to the predicate, as verified through bench testing.
The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable.

In conclusion, the document describes the clearance of a medical device (a mobile X-ray system) based on substantial equivalence to a predicate, not the performance claims of a novel AI/ML-based diagnostic or analytical tool. Therefore, it does not provide the specific information requested about acceptance criteria and studies for AI/ML device performance.

Summary

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July 17, 2020

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

Micro-X Ltd. % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K201488

Trade/Device Name: Rover Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL, MQB Dated: June 1, 2020 Received: June 4, 2020

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

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

Enclosure

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Indications for Use

510(k) Number (if known) K201488

Device Name Rover

Indications for Use (Describe)

The device is designed to perform radiographic x-ray examinations on pediatric and adult patients treatment areas.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary: 510(k) Number K201488

Image /page/3/Picture/1 description: The image shows the logo for MICRO-X. The word "MICRO" is in a dark gray color, and the "-X" is in a light green color. The font is sans-serif and modern.

Limited A14 6 MAB Eastern Promenade, Tonsley (Clovelly Park), South Australia 5042 Phone: +61 8 7099 3966 Email: admin@micro-x.com Date: July 14, 2020 Prepared by: Derek Rogers, Quality and Regulatory Manager

1) Identification of the Device:

Trade/Device Name: Rover Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Codes: IZL, MQB. Common/Usual Name: Digital Mobile Diagnostic X-Ray System

2) Equivalent legally marketed device: K173924,

Trade/Device Name: DRX-Revolution Nano Mobile X-ray System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Codes: IZL, MQB. Common/Usual Name: Digital Mobile Diagnostic X-Ray System

3) Reference devices: We employ these cleared devices without modification:

Fujifilm FDR D-EVO Series: K142003; K192932 i) Regulation Number: 21 CFR 892. 1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB
ii) The Fuji FDX Console Advance DR-ID 300CL Software cleared in K192932 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ
1. Indications for Use: The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas.
1. Description of the Device: The Rover product concept was developed under a contract from the Australian Department of Defense to fulfil a need for a full performance digital medical x-ray imager, light enough to be used in deployed medical facilities. Key Design Features:

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Full trauma imaging capability 40-110kV, 0.2-20mAs;
Ultra-light weight at 105 kg;
Ground Clearance allows for 75mm step up;
Operation on uneven ground;
Spare battery tray swap out in under a minute;

The unit uses FDA cleared digital image capture panels and software made by FujiFilm.

Characteristic	DRX-Revolution Nano Mobile X-ray SystemK173924	Rover, K201488
Indications forUse:	The device is designed to performradiographic x-ray examinations on pediatricand adult patients, in all patient treatmentareas.	The device is designed to perform radiographicx-ray examinations on pediatric and adultpatients, in all patient treatment areas. SAME
Configuration	Battery Operated Mobile System with digitalx-ray panel and image acquisition computer	SAME
Generator	Maximum 4.8 kW @ 104 msec and 7.7 kW@ 13 msec40 – 110 kV0.2 – 20.0 mAs30 – 70 mA	Maximum 4.8 kW @ 104 msec and 7.7 kW @13 msec of power40 – 110 kV0.2 - 20.0 mAs30 – 70 mASAME
Photos	DRX-Revolution Nano MobileImage: DRX-Revolution Nano Mobile	RoverImage: RoverVery similar appearance and functionality
Digital X-rayPanel Supplied	Carestream DRX Family: K153142; K183245;K183474. 14" x 17" and 17" x 17" sizes.	Fujifilm FDR D-EVO Series, all FDA clearedK142003; K192932; 24x30cm, 14" x 17" and 17"x 17" sizes (CSL & GOS) Equivalent.
Software	Carestream DirectView	The Fuji FDX Console Advance DR-ID 300CLSoftware cleared in K192932
Panel Interface	Ethernet or Wi-Fi wireless	SAME
Characteristic	DRX-Revolution Nano Mobile X-ray SystemK173924	Rover, K201488
OperatingSystem	Windows 7	Windows 10
Meets USPerformanceStandard	Meets all applicable requirements of21 CFR 1020.30 and 21CFR 1020.31	SAME
Power Source	AC Line or Battery	SAME but the system has the additional featureof having a swap-out battery tray so the systemdoes not have to limit use while plugged in toan AC line for charging.

6) Substantial Equivalence Chart

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1. The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness. Safety and Effectiveness, comparison to predicate device. The results of bench testing indicate that the new devices are as safe and effective as the predicate devices. Proper system operation is fully verified upon installation. We verified that the modified combination of components worked properly and produced diagnostic quality images as good as our predicate generator/panel combination.
1. Summary of non-clinical testing: Systems covering all generator/panel combinations were assembled and tested and found to be operating properly. Software was validated according to the FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005. Because the system uses Wi-Fi and Ethernet, we observed the recommendations contained in the FDA Guidance Document: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014. The digital panel software employed was already reviewed by FDA. Labeling was developed and information provided in accordance with this FDA Guidance Document: Pediatric Information for X-ray Imaging Device Premarket Notifications, Guidance for Industry and Food and Drug Administration Staff, November 2017. Labeling also includes reference to the Image Gently website (http://www.imageqently.org/). Because the device contains wireless technology, we consulted Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff, AUGUST 2013 and we incorporated those recommendations into our labeling.

The Rover Battery Mobile X-Ray Units have been tested to be in compliance with the following Standards:

US Performance Standard for Diagnostic X-Ray Systems: 21 CFR 1020.30 AND 21 CFR 1020.31.

IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012- Medical Electrical Equipment, Part 1: General requirements for basic safety and essential performance.

IEC60601-1-2:2014 Medical electrical equipment Collateral Standard: Electromagnetic compatibility Requirements and tests.

IEC 60601-1-3:2008 (Second Edition) + A1:2013 for use in conjunction with IEC 60601-1:2005 (Third Edition) + A1:2012

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IEC 60601-1-6:2010 (Third Edition) + A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

IEC 60601-2-28:2017 for use in conjunction with 60601-1:2005, COR2:2007, AMD1:2012 (or IEC 60601-1: 2012 reprint) Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis.

IEC 60601-2-54:2009, AMD1:2015 for use in conjunction with IEC 60601-1:2005, AMD1:2012 Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment for Radiography and Radioscopy.

1. Summary of clinical testing: Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance.
1. Conclusion: After analyzing bench and non-clinical tests, it is the conclusion of Micro-X that the new Rover Digital Diagnostic Mobile X-Ray Systems are as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.

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.