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

AcuityDRe components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDRe 1417w, AcuityDRe 1717w, AcuityDRe 1717t. The "w" indicates wireless wi-fi while the "t" indicates tethered. The indications for use remains unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the generator/tubestand combination. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITY + Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K201058.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the AcuityDRe device, which is an upgrade kit for digital x-ray systems. It primarily focuses on demonstrating substantial equivalence to a predicate device (Accuvue+, K201058), rather than detailing a clinical study with specific acceptance criteria and performance against those criteria in a typical sense of an AI/ML medical device.

The "study" cited here is non-clinical testing, specifically clinical image evaluation performed by a Board Certified Radiologist, and bench testing for physical performance characteristics. It's not a comparative effectiveness study involving human readers with and without AI assistance, nor a standalone AI performance study.

Here's an attempt to extract and present the information based on the provided text, acknowledging that many requested fields regarding AI/ML device studies are not applicable or detailed in this 510(k) summary for an x-ray hardware upgrade kit.

Device: AcuityDRe (Digital X-ray System Upgrade Kit)

Description of Testing (Non-Clinical and Image Evaluation)

The primary goal of the testing was to demonstrate substantial equivalence of the AcuityDRe system (comprising new digital x-ray receptor panels, software, and generator compatibility) to a legally marketed predicate device (Accuvue+, K201058). This was achieved through:

Bench testing for physical performance characteristics of the new digital x-ray panels.
Clinical image evaluation by a Board Certified Radiologist to assess image quality.
Confirmation of compliance with relevant medical device standards and FDA guidance documents.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this 510(k) is for an X-ray system upgrade kit rather than an AI/ML algorithm, the "acceptance criteria" are not framed as typical AI performance metrics (e.g., sensitivity, specificity, AUC). Instead, the key "acceptance criteria" are based on demonstrating substantial equivalence to the predicate device in terms of:

Same Indications for Use
Similar Technological Characteristics (especially panel performance: DQE, MTF, and panel sizes)
Compliance with safety and performance standards.
"Excellent quality" of clinical images as assessed by an expert.

Feature / Criteria (Implied for Substantial Equivalence)	Acceptance Criteria (Compared to Predicate / Standards)	Reported Device Performance (AcuityDRe)	Comparison Result
Indications for Use	Same as predicate.	"Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography." - SAME as predicate.	SAME
X-ray Generator Compatibility	Compatible with CPI or Sedecal generators.	Compatible CPI generators: CMP 200 Series. Compatible Sedecal generators: SFHR and SHF Series. - SAME as predicate. Software control of technique factor possible with certain compatible generators.	SAME
Digital X-Ray Detectors	New models, but comparable performance and size.	AcuityDRe 1417w, AcuityDRe 1717w, AcuityDRe 1717t. New models had not received previous FDA clearance, hence testing was performed for them.	SAME (as new versions)
Panel Performance (DQE @ 1.0 lp/mm)	Comparable to predicate's DQE.	AcuityDRe 1417w: 35% (Predicate AcuityDR 1417: 34.6%) AcuityDRe 1717w/1717t: 42% (Predicate AcuityDR 1717: 23.6%) (Note: The AcuityDRe 1717w/1717t shows improved DQE compared to the predicate's AcuityDR 1717, which is a positive attribute for image quality).	Almost IDENTICAL / Improved for some models
Panel Performance (MTF @ 2.0 lp/mm)	Comparable to predicate's MTF.	AcuityDRe 1417w: 31% (Predicate AcuityDR 1417: 34%) AcuityDRe 1717w/1717t: 38% (Predicate AcuityDR 1717: 34%) (Note: Ranges are close, with slight variations).	Almost IDENTICAL
Panel Sizes	Comparable to predicate's sizes.	AcuityDRe 1417w: 148 µm AcuityDRe 1717w: 140 µm AcuityDRe 1717t: 140 µm (Predicate AcuityDR 1417: 140µm; AcuityDR 1717: 140μm)	Almost IDENTICAL
Operator Console	Windows PC using Windows 10-IoT.	SAME	SAME
Acquisition Software	AccuVue / AccuVue+.	SAME	SAME
Power Source	AC Line or rechargeable batteries.	SAME	SAME
Compliance with Standards	Demonstrated compliance with listed standards.	IEC 60601-1:2005/(R)2012 And A1:2012 (Medical Electrical Equipment Safety) IEC 60601-1-2:2014 (Electromagnetic Disturbances) NEMA PS 3.1 - 3.20 (2011) (DICOM Set) - SAME as predicate.	SAME
Clinical Image Quality	"Of excellent quality" (qualitative assessment).	"The images were found to be of excellent quality." (Qualitative assessment by expert)	Achieved

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

Test Set Sample Size: Not explicitly stated numerically for the clinical image evaluation. The text only mentions "Clinical image evaluation was performed on the proposed new panels."
Data Provenance: Not specified. It's likely retrospective, as it's an evaluation of images generated by the new panels. Country of origin not mentioned; presumed to be images from typical clinical settings where such panels would be used.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: One.
Qualifications: A "Board Certified Radiologist." Further details like years of experience are not provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/None, as only a single expert was used for the qualitative assessment of image quality.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This type of study (AI vs. human-assisted AI) was not performed as the device is an x-ray system upgrade, not an AI diagnostic algorithm.
Effect Size of Human Reader Improvement: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: No, as the device itself is a component of an x-ray system, not a standalone AI algorithm. The image quality assessment was of the images produced by the hardware, which would then be interpreted by humans.

7. Type of Ground Truth Used

Ground Truth Type: Expert Consensus / Qualitative Expert Assessment. The "ground truth" for the image quality was the subjective assessment by the Board Certified Radiologist that the images were "of excellent quality." This is distinct from, for example, pathology-confirmed diagnoses or patient outcomes data.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is a hardware component (digital x-ray panels) and associated software, not an AI/ML algorithm that requires a "training set" in the context of machine learning model development. The software mentioned (AccuVue/AccuVue+) has received previous clearance for control of generators.

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

Ground Truth Establishment for Training Set: Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this device.

Summary

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April 30, 2021

Image /page/0/Picture/1 description: The image contains 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.

Radmedix LLC % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 45409

Re: K210919

Trade/Device Name: AcuityDRe Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, LLZ Dated: March 26, 2021 Received: March 29, 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 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) K210919

Device Name AcuityDRe

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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K210919

Image /page/3/Picture/1 description: The image shows the logo for RadmediX. The logo features a large, stylized "R" in blue, with the word "admedi" in a smaller font size next to it. Behind the blue "R" and "admedi" is a faded gray "RX". The "X" in "RadmediX" is also in blue.

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 AcuityDRe

Submitter:
Submission contact person:	Gabriel Issa, Director of Equipment
Contact telephone:	844 723 6334
Contact e-mail:	gabe@radmedix.com
Date prepared:	April 28, 2021

Identification: AcuityDRe (Three models: AcuityDRe 1417w, AcuityDRe 1717w, AcuityDRe 1717t) Classification Name: Stationary X-Ray System Classification Panel: Radiology Classification Regulation: 21 CFR §892.1680 Device Class: Class II Product Code: MQB, LLZ Substantially equivalent device: Trade Name: Accuvue+ Manufacturer: RadmediX 510(k) #: K201058 Classification Name: Stationary x-ray system Classification Panel: Radiology Classification Regulation: 21 CFR §892.1680 Device Class: Class II Product Code: MQB, LLZ

1. Device description: AcuityDRe components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDRe 1417w, AcuityDRe 1717w, AcuityDRe 1717t. The "w" indicates wireless wi-fi while the "t" indicates tethered. The indications for use remains unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the generator/tubestand combination. Each system consists of the following items:
  Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITY + Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K201058.
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.

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4. Technological characteristics: Comparison Table

ComparableProperties	Accuvue+, K201058	AcuityDRe	ComparisonResults
Indications foruse	Intended for use by a qualified/trainedphysician or technician on both adultand pediatric subjects for takingdiagnostic x-rays. Not formammography.	Intended for use by a qualified/trainedphysician or technician on both adultand pediatric subjects for takingdiagnostic x-rays. Not formammography.	SAME
X-ray Generator	Supplied by User: CPI or Sedecal	Supplied by User: CPI or Sedecal	SAME
Software Controlof TechniqueFactor	Possible for certain CPI or SedecalGenerators (Validated previously). Seebelow.l	Possible for certain CPI or SedecalGenerators (Validated previously). Seebelow.	SAME
Digital X-RayDetectors	DRTech 4343A, (K192400);DRTech 4343W, (K193017);AcuityDR (K171137);AcuityDR 1417 (K162552);AcuityDR 1717 (K162555)	AcuityDRe 1417w,AcuityDRe 1717w,AcuityDRe 1717t	SAME
PanelPerformance	AcuityDR 1417 (K162552);DQE 34.6 %at 1 lp/mm MTF 34 % at 2 lp/mmAcuityDR 1717 (K162555) DQE 23.6 % at1 lp/mm MTF 34 % at 2.0 lp/mm	AcuityDRe 1417w: DQE @ 1.0 lp/mm:35%; MTF @ 2.0 lp/mm: 31%AcuityDRe 1717w/1717t: DQE @ 1.0lp/mm: 42%; MTF @ 2.0 lp/mm: 38%	AlmostIDENTICAL
Panel Sizes	AcuityDR 1417 140µmAcuityDR 1717 140μm	AcuityDRe 1417w 148 µmAcuityDRe 1717w 140 µmAcuityDRe 1717t 140 µm	AlmostIDENTICAL
Operatorconsole	Windows PC using Windows 10-IoT	SAME	SAME
AcquisitionSoftware	Customer Selects:AccuVueAccuVue+	SAME	SAME.
Power Source	AC Line or rechargeable batteries(wireless models)	AC Line or rechargeable batteries(wireless models)	SAME.
Standards	Same as below	See below	SAME

5. Non clinical testing: Testing was performed 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
12-238	NEMA	PS 3.1 - 3.20 (2011)	NEMA Digital Imaging and Communications in Medicine (DICOM)Set

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The digital panel software employed was used unmodified from FDA. The software has been validated as a control for CPI and Sedecal diagnostic x-ray generators. Compatible CPI generators: CMP 200 Series. Compatible Sedecal generators: SFHR and SHF Series.

In recognition of possible cybersecurity threats to the software, we consulted this guidance: Content of Premarket Submissions for Manaqement of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff October 2014. As a result, we updated our own internal standard operating procedures and added cybersecurity precautions to the software users' manuals.

In recognition of FDA pediatric concerns, we reviewed the FDA guidance: Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff and created labeling to comply with this guidance.

In recognition of FDA's concerns about wireless performance we reviewed the FDA guidance: Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and Food and Drug Administration Staff. Both the predicate and subject devices use the same wireless technology, standard Wi-Fi using FCC approved off the shelf components.

Since the three new digital receptor panels have not had previous FDA clearance, testing was performed according to the FDA guidance document: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, Guidance for Industry and Food and Drug Administration Staff. Clinical image evaluation was performed on the proposed new panels by a Board Certified Radiologist. The images were found to be of excellent quality. Performance characteristics are as follows:

DQE @ 1.0 lp/mm: 0.35; MTF @ 2.0 lp/mm: 0.31 AcuityDRe 1417w:

AcuityDRe 1717w: DQE @ 1.0 lp/mm: 0.42; MTF @ 2.0 lp/mm: 0.38

AcuityDRe 1717t: DQE @ 1.0 lp/mm: 0.42; MTF @ 2.0 lp/mm: 0.38

All proposed compatible generators carry NRTL listing labels, having been tested for safety. Validation of proper generator technique control had been previously performed.

Each system is tested for proper integration prior to the customer. Since multiple configurations are available (generator and panel models), our service engineers fully test each new system upon installation at the customer site

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

7. Substantial Equivalence Discussion.

When combined with a compatible generator/Tubestand combination the AcuityDRe performs the same functions as the predicate using the same technological methods to produce diagnostic x-ray images. In all material aspects, the Accuvue+ and the AcuityDRe 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 AcuityDRe series of upgrade kits are 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

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.