Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

Device Description

RadmediX AcuityPDR combines components into a complete mobile x-ray system, including software, a generator/collimator combination, and digital radiography panels. Radmedix combines components from various manufacturers into a complete mobile x-ray system. The customer selects one (or more) of the following digital x-ray receptor panels: DRTech 4343A, (K192400); DRTech 4343W, (K193017); AcuityDR (K171137); AcuityDR 1417 (K162552 EVS 3643, EVS 3643G) or AcuityDR 1717 (K162555 EVS 4343, EVS 4343G). In addition, the customer selects one of three software packages: Accuvue+ (K130883), AccuVueMED, (K152172) or AccuVue (K141440). The generator can be battery operated. A single battery charge produces 200 Exposures at max KV and MAS settings. The battery charger is UL Listed and the internal lithium ion battery is overcharge and overcurrent protected. A typical acquisition computer would be a Lenovo P53S or a Dell Precision 3541.

AI/ML Overview

This document describes a medical device, AcuityPDR, a mobile X-ray system, and its 510(k) submission for FDA clearance. The submission relies on demonstrating substantial equivalence to a predicate device (MinXray CMDR 2CW).

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state acceptance criteria in the form of quantitative performance metrics for the AcuityPDR device itself. Instead, it focuses on demonstrating "substantial equivalence" to a predicate device. The acceptance criteria for this type of submission are typically that the device performs as safely and effectively as the predicate and has the same indications for use.

The device performance is reported implicitly through the comparison table on page 4, showing that the AcuityPDR either matches or has comparable/equivalent functionality to the predicate in various technical parameters.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (AcuityPDR vs. Predicate CMDR 2CW)
Indications for Use (Identical)	Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. (Identical)
X-ray Tube Functionality (Equivalent/Comparable)	TOSHIBA D-125SB (Equivalent Functionality)
Peak Generator Output (Same)	2 kW (SAME)
Tube Current Range (Comparable)	40-60kV: 25mA, 61-100kV: 20mA (Comparable ranges)
Tube Voltage Adjustable Range (More Flexible)	40-100kV, step value 1kV (More flexible kV adjustment)
mAs Range (Comparable Adjustability)	0.4mAs ~ 50mAs (Comparable adjustability)
Collimator (Equivalent Functionality)	Built in (Equivalent Functionality)
X-ray Generator (Equivalent Functionality)	One model, up to 100 kVp (Equivalent Functionality)
Digital X-Ray Detectors (Equivalent Functionality)	DRTech 4343A, DRTech 4343W, AcuityDR (various models) (Equivalent Functionality)
Operator Console (Similar Functionality)	SAME (Touch Control or Touch Screen) (Similar Functionality)
Acquisition Software (Equivalent Functionality)	AccuVueMED, AccuVue, or AccuVue+ (Equivalent Functionality, only cleared software supplied)
Power Source (Same)	AC Line or rechargeable batteries (Generator only) (SAME)
Compliance with Standards (Same)	60601-1:2005; 60601-1-2:2014, etc. (SAME)

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

The document explicitly states in section 6, "Clinical testing. Not required for a determination of substantial equivalence." This indicates that no clinical test set was used for this specific submission. The submission relies on non-clinical testing (bench testing, standards compliance) and comparison to the predicate device.

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)

Since no clinical test set was required or used for this submission, there is no mention of experts being used to establish ground truth for a test set.

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

As no clinical test set was used, no adjudication method is mentioned.

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 study was performed as clinical testing was "Not required for a determination of substantial equivalence." The device is a mobile X-ray system, not an AI-powered diagnostic tool, so the concept of human readers improving with AI assistance is not applicable in this context.

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

This is not an AI algorithm; it's a mobile X-ray system. Therefore, standalone algorithm performance is not applicable. The performance is assessed through compliance with electrical and safety standards for X-ray devices and comparison of technical specifications to a predicate.

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

For this type of 510(k) submission, "ground truth" is primarily established by:

Compliance with recognized electrical, safety, and performance standards for X-ray generating equipment (e.g., IEC 60601 series, 21 CFR 1020).
Demonstration that the device's technical specifications and intended use are substantially equivalent to a legally marketed predicate device.
Component certifications: "All of the components subject to the CDRH performance standard are certified to comply with the standard by their respective manufacturers."

8. The sample size for the training set

The document does not describe a training set for an AI model, as this is not an AI device. The "training" for such a device would refer to its design and manufacturing processes adhering to established engineering principles and standards.

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

Not applicable, as no AI model or training set is described. The "ground truth" for the device's design and manufacturing relies on established medical device regulations, design controls, and industry standards for X-ray imaging equipment.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Radmedix LLC % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

April 13, 2020

Re: K200726

Trade/Device Name: AcuityPDR Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL, MQB, LLZ Dated: March 17, 2020 Received: March 20, 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) K200726

Device Name AcuityPDR

Indications for Use (Describe)

Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

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 K200726

Image /page/3/Picture/1 description: The image shows a logo with the text "RadmediX". The letters "R" and "X" are in blue, while the letters "R", "m", "e", "d", and "i" are in gray. The logo is likely for a company or organization with the name RadmediX.

RadmediX, LLC 2510 Lance Rd. Dayton, OH 45409 Tel 844 723 6334 Registration Number: 3009134655

1. Administrative Information

Reason for Submission: 510(k) Notification for RadmediX AcuityPDR

Submitter:	Submission contact person:	Gabriel Issa, Director of Equipment
	Contact telephone:	844 723 6334
	Contact e-mail:	gabe@radmedix.com
	Date prepared:	April 9, 2020
Identification:	Classification Name:	AcuityPDR
	Classification Name:	Mobile X-Ray System
	Classification Panel:	Radiology
	Classification Regulation:	21 CFR §892.1720
	Device Class:	Class II
	Product Code:	IZL, MQB, LLZ
Substantially equivalent device:	Trade Name:	CMDR 2CW
	Manufacturer:	MinXray
	510(k) #:	K191451
	Classification Name:	Mobile X-Ray System
	Classification Panel:	Radiology
	Classification Regulation:	21 CFR §892.1720
	Device Class:	Class II
	Product Code:	IZL, MQB, LLZ

1. Device description: RadmediX AcuityPDR combines components into a complete mobile x-ray system, including software, a generator/collimator combination, and digital radiography panels. Radmedix combines components from various manufacturers into a complete mobile x-ray system. The customer selects one (or more) of the following digital x-ray receptor panels: DRTech 4343A, (K192400); DRTech 4343W, (K193017); AcuityDR (K171137); AcuityDR 1417 (K162552 EVS 3643, EVS 3643G) or AcuityDR 1717 (K162555 EVS 4343, EVS 4343G). In addition, the customer selects one of three software packages: Accuvue+ (K130883), AccuVueMED, (K152172) or AccuVue (K141440). The generator can be battery operated. A single battery charge produces 200 Exposures at max KV and MAS settings. The battery charger is UL Listed and the internal lithium ion battery is overcharge and overcurrent protected. A typical acquisition computer would be a Lenovo P53S or a Dell Precision 3541.

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1. Indications for Use: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

ComparableProperties	CMDR 2CW, made by MinXray510(k) #: K191451	AcuityPDR	ComparisonResults
Indicationsfor use	Intended for use by aqualified/trained physician ortechnician on both adult andpediatric subjects for takingdiagnostic x-rays. Not formammography.	Intended for use by aqualified/trained physician ortechnician on both adult andpediatric subjects for takingdiagnostic x-rays. Not formammography.	Identical
X-ray tube	Toshiba D-124S	TOSHIBA D-125SB 100kV, 40mA	EquivalentFunctionality
Peakgeneratoroutput	2 kW	2 kW	SAME
Tube currentrange	30 mA±20% at 60kV mA25 mA±20% at 80kV mA20 mA±20% at 100kV	40-60kV: 25mA.61-100kV: 20mA.	Comparableranges.
Tube voltageadjustablerange	40-100 kV, 2kV steps	40-100kV, step value 1kV.	More flexiblekVadjustment
mAs range	2.0-150 (steps not specified)	0.4mAs ~ 50mAs, with the range of:0.40, 0.50, 0.63, 0.80, 1.00, 1.25, 1.6,2.0, 2.5, 3.2, 4.0, 5.0, 6.3, 8, 10, 12.5, 16,20, 25, 32, 40, 50.	Comparableadjustability
Collimator	Built in	Built in	EquivalentFunctionality
X-rayGenerator	Three models, from 100 to 120 kVpmaximum	One model, up to 100 kVp	EquivalentFunctionality
Digital X-RayDetectors	K150929 CareView 1500Cw X-ray FlatPanel Detector manufactured byCareRay	DRTech 4343A, (K192400);DRTech 4343W, (K193017);AcuityDR (K171137);AcuityDR 1417 (K162552);AcuityDR 1717 (K162555)	EquivalentFunctionality
Operatorconsole	Touch Control or Touch Screen	SAME	SimilarFunctionality
ComparableProperties	CMDR 2CW, made by MinXray510(k) #: K191451	AcuityPDR	ComparisonResults
AcquisitionSoftware	dicomPACS® DX-R K141440	Customer Selects:AccuVueMED (K152172)AccuVue (K141440) orAccuVue+ (K130883)	EquivalentFunctionalityOnly clearedsoftware issupplied.
Photos	Image: CMDR 2CW	Image: AcuityPDR	Similar formfactors
Power Source	AC LINE, single or three phasedepending on the generator	AC Line or rechargeable batteries(Generator only)	SAME.
Standards	60601-1:2005; 60601-1-2:201421CFR1020	SAMEGenerators are TUV TestedAC Line Power Supply is UL ListedSee list below.	SAME

4. Technological characteristics: Comparison Table

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Non clinical testing: Testing was performed successfully according to the following standards:

FDARecognitionNumber	StandardDevelopingOrganization	Standard DesignationNumber And Date	Title Of Standard
19-4	IEC	60601-1:2005/(R)2012And A1:2012	Medical Electrical Equipment Part 1: General Requirements ForBasic Safety And Essential Performance (IEC 60601 1:2005, MOD)
19-1	IEC	60601-1-2:2014	Medical Electrical Equipment Part 12: General Requirements ForBasic Safety And Essential Performance Collateral Standard:Electromagnetic Disturbances Requirements And Tests

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FDARecognitionNumber	StandardDevelopingOrganization	Standard DesignationNumber And Date	Title Of Standard
12-269	IEC	60601-1-3 Edition 2.12013-04	Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard:Radiation protection in diagnostic X-ray equipment
12-296	IEC	60601-2-54 -2009+AMD1 :2015+AMD2:2018	Particular Requirements For The Basic Safety And EssentialPerformance Of X-Ray Equipment for Radiography andRadioscopy
12-238	NEMA	PS 3.1 - 3.20 (2011)	NEMA Digital Imaging and Communications in Medicine (DICOM)Set
N/A	FDA	21CFR1020	Electronic Products; Performance Standard for Diagnostic X-RaySystems and Their Major Components

All of the components subject to the CDRH performance standard are certified to comply with the standard by their respective manufacturers. We do not supply any non-certified components. Applicable components carry a certification label (UL, ETL, etc.). The digital panel software employed was used unmodified from clearances obtained from FDA. Since multiple configurations are available, our service engineers fully test each new system upon installation at the customer site. In recognition of possible cybersecurity threats to the software, we consulted this guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Druq Administration Stoff October 2014. As a result, we updated our own internal standard operating procedures and added cybersecurity precautions to the software users' manuals. The generator User Manual has been updated to add Pediatric Considerations. Each system is tested for proper integration prior to shipment to the customer.

Clinical testing. Not required for a determination of substantial equivalence.

7. Substantial Equivalence Discussion.

The RadmediX AcuityPDR performs the same functions using the same technological methods to produce diagnostic x-ray images. In all material aspects, the Visaris and the RadmediX systems are substantially equivalent to each other.

8. Substantial Equivalence Conclusion:

After analyzing bench test results, risk analysis, and clinical evaluation, it is the conclusion of RadmediX LLC that the RadmediX AcuityPDR is as safe and effective as the predicate device, has 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.