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 OR Varex.

AI/ML Overview

The provided document is a 510(k) summary for a mobile x-ray system (ROVER) and does not describe acceptance criteria for an AI/ML device or detailed studies proving such a device meets those criteria. The document focuses on establishing substantial equivalence for a hardware medical device to previously cleared devices.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC comparative effectiveness, ground truth type, training set size and ground truth establishment methods) are not applicable or cannot be extracted from this document as it pertains to an X-ray system, not an AI/ML diagnostic aid.

Here's the information that can be extracted or inferred:

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

The document does not specify quantitative acceptance criteria in terms of diagnostic performance metrics for an AI/ML device. Instead, it relies on regulatory standards and the equivalence to predicate devices. The "reported device performance" is essentially that it operates properly and produces diagnostic quality images.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with US Performance Standard for Diagnostic X-Ray Systems (21 CFR 1020.30)	"YES 21 CFR 1020.30"
Compliance with IEC 60601-1 (General requirements for basic safety and essential performance)	Tested and found to be compliant.
Compliance with IEC 60601-1-2 (EMC)	Tested and found to be compliant.
Compliance with IEC 60601-1-3 (Radiation protection in diagnostic X-ray equipment)	Tested and found to be compliant.
Compliance with IEC 60601-1-6 (Usability)	Tested and found to be compliant.
Compliance with IEC 60601-2-28 (X-ray tube assemblies)	Tested and found to be compliant.
Compliance with IEC 60601-2-54 (X-ray equipment for radiography and radioscopy)	Tested and found to be compliant.
Proper system operation and diagnostic quality images	"worked properly and produced diagnostic quality images"
Software Validation (per FDA Guidance May 11, 2005)	"Software was validated"
Cybersecurity management (per FDA Guidance October 2, 2014)	"observed the recommendations"

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document states "Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance." The testing described is bench testing and verification of system operation, not a clinical study with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical test set requiring expert ground truth was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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 an X-ray system, not an AI diagnostic aid requiring MRMC studies to assess reader improvement.

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

Not applicable. This is an X-ray system, not an AI algorithm.

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

Not applicable, as no clinical test set requiring ground truth was used. The focus was on engineering verification and compliance with standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set mentioned.

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

Not applicable.

Summary

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Image /page/0/Picture/0 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

May 21, 2021

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

Re: K211423

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: May 6, 2021 Received: May 7, 2021

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

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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 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 (OS) 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,

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) K211423

Device Name ROVER

Indications for Use (Describe)

The device is designed to perform radiographic x-ray examinations on pediatric and adult 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: 510(k) Number K211423

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 the letters are all capitalized.

Limited A14 6 MAB Eastern Promenade, Tonsley (Clovelly Park), South Australia 5042 Phone: +61 8 7099 3966 Email: admin@micro-x.com Date: May 18, 2021 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: K201488, Micro-X Limited

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

a) For Model MXU-RV01:

i) Fujifilm FDR D-EVO II & III Series: K142003; K192932 Regulation Number: 21 CFR 892. 1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB ii) FDX Console (DR-ID300CL) Software K170451, K192932 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ

b) For Model MXU-RV19:

Nexus DR Digital X-Ray Imaging System K161459. (Supports digital panels 4336W and 4343W) Regulation Number: 21 CFR 892. 1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB

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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:
- 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 OR Varex.

Characteristic	Rover, K201488	Rover, K21__________(Two models: MXU-RV01, MXU-RV19)
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 msec; 40 - 110 kV; 0.2 – 20.0 mAs30-70 mA	Maximum 4.8 kW @ 104 msec and 7.7 kW @13 msec; 40 – 110 kV; 0.2 – 20.0 mAs;30-70 mA SAME
		Model MXU-RV01	Model MXU-RV19
Digital X-rayPanelSupplied	Fujifilm FDR D-EVO Series, all FDA clearedK142003; K192932; 24x30cm, 14" x 17" and17" x 17" sizes (CSL & GOS) Equivalent.	Fujifilm FDR D-EVOSeries, all FDA clearedK142003; K192932;24x30cm, 14" x 17" and17" x 17" sizes (CSL &GOS) (SAME).	Varex PaxScanSeries, allFDA clearedK161459,Panel models4336W and. 4343W14" x 17", 17" x 17"Equivalent.
Software	The Fuji FDX Console Advance DR-ID 300CLSoftware cleared in K192932	The Fuji FDX ConsoleAdvance DR-ID 300CLSoftware cleared inK192932 (SAME)	Varex Nexus DRSoftware, FDAcleared inK161459.Equivalent.
PanelInterface	Ethernet or Wi-Fi wireless	SAME	Wifi wireless only

6) Substantial Equivalence Chart

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Characteristic	Rover, K201488	Rover, K21______(Two models: MXU-RV01, MXU-RV19)
Wi-Fi access point	D-Link DAP 2553 dual-band 2.4Ghz/5Ghz	D-Link DAP2610 2.4GHz or Lancom LW-600 dualband 2.4Ghz/5Ghz	Lancom LW-600 dualband 2.4Ghz/5Ghz
Operating System	Windows 10	Windows 10	Windows 10
Meets US Performance Standard	YES 21 CFR 1020.30	SAME
Power Source	AC Line or Battery	SAME but the system has the additional optional feature of having a swap-out battery tray to allow for extended use while not connected to AC line for charging.
Photo	Image: Rover K201488	Image: Rover K21

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 Druq Administration Staff Document Issued on: October 2, 2014. The digital panel software employed was already reviewed by FDA. The Rover Battery Mobile X-Ray Units have been tested to be in compliance with the following Standards:

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

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

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, COR1:2006, 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 our risk assessments, it is the conclusion of Micro-X that the modified 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.