The iQFlex Pro Mobile X-ray System is a medical device intended for use by a qualified/trained physician or technician for handheld diagnostic imaging of body extremities. The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device may be used for stand mounted imaging of the chest. - Not to be used on bariatric patients, unless imaging body extremities. Not for mammography use. Not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.

Device Description

This Mobile X-ray System (Model: iQFlex Pro) consists of a LED display with up and down soft-keys for controlling kVp, an X-ray generator, an X-ray tube assembly, and a collimator. In addition, this unit has preset memory keys to store and select kVp/mAs. The iQFlex Pro can be used with a flat panel detector of choice. The subject device iQFlex Pro is not being provided with digital detectors. This device is a battery-powered mobile X-ray system, designed and manufactured by First Source Inc. Compared with traditional X-ray products, this device has exquisite structure, compact design, light weight and easy operation. The major components of the X-ray main unit include: handle, enclosure, main/sub console board, high-voltage tank, inverter, collimator (beam limiter), and system control software running on the main console board. The system control software is for real-time interaction and control with various circuit modules inside the X-ray generator. The software responds to user operations on the main console board. The user can adjust and control the kVp and mAs parameters, and the software will display the parameters or directly load the APR parameters. The software loads the control data from X-ray output into the high-voltage generation control circuit of the inverter, and control the high-voltage tank to generate high-voltage to excite the X-ray tube inside to emit X-rays, control the switch of the collimator indicator, and monitor the working status of the device, and control the display of the status indicators. The system is for X-ray imaging and diagnosis in medical facilities with mobile or fixed sites. The iQFlex Pro is not intended for mammography. Detectors are recommended but not provided with the iQFlex system. Detectors chosen must have been cleared by FDA have reasonable MTF and DQE values. The iQFlex Pro is not a cybersecurity device, however it has firmware and a USB-C port. The USB-C port is for battery charging only. The iQFlex Pro generator doesn't connect to the Internet, to other medical devices, and the supporting software doesn't offer a protocol for transfer of medical data.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the iQFlex Pro Mobile X-ray System. It outlines the device's technical specifications, intended use, and comparison to a predicate device. Crucially, the document focuses on compliance with general medical device standards and does not contain information about specific AI/algorithm performance acceptance criteria, nor does it detail a study proving such an algorithm meets those criteria. The "Image Quality Evaluation" section mentions a Board Certified Radiologist's review of diagnostic quality images, but this is a general assessment of the hardware's output, not a detailed AI performance study.

Therefore, many of the requested details about acceptance criteria, AI performance studies, sample sizes, ground truth establishment, MRMC studies, etc., cannot be extracted from the provided text because the device, as described, does not appear to incorporate an AI algorithm for diagnostic purposes. It is a Mobile X-ray System, a hardware device for generating X-ray images, not an AI-powered diagnostic tool.

However, I can extract information related to the device's overall testing and how it meets its intended purpose.

Here's a summary of the available information based on the provided text, highlighting what is present and what is absent:

Device: iQFlex Pro Mobile X-ray System
Regulation Number: 21 CFR 892.1720
Regulation Name: Mobile X-Ray System
Product Code: IZL

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

The document does not present a formal table of "acceptance criteria" for an AI algorithm. Instead, it lists the standards to which the device conforms and generally states that "Predefined acceptance criteria were met." The performance is described in terms of compliance with these standards and the subjective assessment of image quality.

Acceptance Criteria (General Device Performance)	Reported Device Performance
Compliance with US FDA Radiation Safety Performance Standard, Sec. 21CFR1020.30	Conforms to standard.
Compliance with IEC 60601-1 Ed. 3.2 (General requirements for basic safety and essential performance)	Conforms to standard (FDA Recognition Number 19-49).
Compliance with IEC 60601-1-2 (Electromagnetic disturbances)	Conforms to standard (FDA Recognition Number 19-36). EMC Testing performed for both Class B environments.
Compliance with IEC 60601-1-3 (Radiation protection in diagnostic X-ray equipment)	Conforms to standard (FDA Recognition Number 12-269).
Compliance with IEC 60601-1-6 (Usability)	Conforms to standard (FDA #5-132).
Compliance with IEC 60601-2-54 (X-ray equipment for radiography and radioscopy)	Conforms to standard (FDA Recognition 12-317).
Electrical safety and electromagnetic compatibility (EMC) compliance with IEC 60601-1:2005/AMD1:2012 and IEC 60601-1-2:2014	Conducted and compliant.
Software Verification and Validation Testing	Documentation provided as recommended by FDA guidance; software is considered "moderate" level of concern.
Diagnostic Image Quality (Hardware Output)	Test images of head, chest, abdomen, and extremities were found to be of excellent diagnostic quality by a Board Certified Radiologist.
Ability to image anatomy other than extremities	Limited clinical test performed; a Board Certified Radiologist performed a successful review.

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

The document mentions "test images" and a "limited clinical test" but does not specify the sample size (number of images or patients) used for the image quality evaluation or the limited clinical test. The provenance (country of origin, retrospective/prospective) is also not mentioned.

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)

For the "Image Quality Evaluation" and the "limited clinical test," a single "Board Certified Radiologist" was used for review. No specific number of years of experience is mentioned beyond "Board Certified."

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

Since only one radiologist was mentioned for the "Image Quality Evaluation" and "limited clinical test," there was no adjudication method (e.g., 2+1, 3+1) described.

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

There is no mention of an MRMC comparative effectiveness study because the device, as described, is a hardware X-ray machine, not an AI-assisted diagnostic tool. Therefore, there's no data on human reader improvement with AI assistance.

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

There is no mention of a standalone algorithm performance study as the device is not presented as containing a diagnostic AI algorithm.

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

For the image quality evaluation, the "ground truth" was the subjective assessment of diagnostic quality by a single Board Certified Radiologist. This is a form of expert consensus, albeit from a single expert.

8. The sample size for the training set

Not applicable/Not mentioned. The document describes a hardware device (X-ray machine), not a machine learning model that would require a "training set."

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

Not applicable/Not mentioned. As above, no training set for an AI algorithm is discussed.

Summary

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July 3, 2024

Image /page/0/Picture/1 description: The image shows the logo for 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below.

First Source Inc. % Daniel Kamm, P.E. Kamm and Associates 8870 Ravello Ct. NAPLES, FL 34114

Re: K240009

Trade/Device Name: iOFlex Pro Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL Dated: November 15, 2023 Received: June 6, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K240009

Device Name iQFlex Pro

Indications for Use (Describe)

Not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types

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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Image /page/3/Picture/0 description: The image shows the logo for 1st Source. The logo is a white circle with the words "1st SOURCE" in bold, teal letters. The number "1st" is stacked on top of the word "SOURCE". There is a teal crescent shape that wraps around the bottom of the circle. Below the logo, the text "510(k) Summary K240009" is written.

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

SUBMITTER 1)

First Source Inc. Address: 3495 Winton Place, Building E, Suite 1, Rochester, NY 14623 Phone: 585.272.1690, Toll Free: 800.349.5980, Fax: 585.272.7678 https://1stsourceimaging.com Email: rviola@fsimed.com Contact Person: Ronald Viola Position: President Date Prepared: July 3, 2024

2) DEVICE

Name of Device: iQFlex Pro Regulation Name: Mobile X-ray system Regulation Number: 892.1720 Regulatory Class: II Product Code: IZL

3) PREDICATE DEVICE

MinXray Inc. K182207 Name of Device: MinXray, MODEL TR90BH Regulation Name: Mobile X-ray system Regulation Number: 21 CFR 892.1720 Regulatory Class: II Primary Product Code: IZL This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

DEVICE DESCRIPTION. This Mobile X-ray System (Model: iQFlex Pro) consists of a LED display with up and down soft-keys for controlling kVp, an X-ray generator, an X-ray tube assembly, and a collimator. In addition, this unit has preset memory keys to store and select kVp/mAs. The iQFlex Pro can be used with a flat panel detector of choice. The subject device iQFlex Pro is not being provided with digital detectors. This device is a battery-powered mobile X-ray system, designed and manufactured by First Source Inc. Compared with traditional X-ray products, this device has exquisite structure, compact design, light weight and easy operation. The major components of the X-ray main unit include: handle, enclosure, main/sub console board, high-voltage tank, inverter, collimator (beam limiter), and system control software running on the main console board. The system control software is for real-time interaction and control with various circuit modules inside the X-ray generator. The software responds to user operations on the main console board. The user can adjust and control the kVp and mAs parameters, and the software will display the parameters or directly load the APR parameters. The software loads the control data from X-ray output into the high-voltage generation control circuit of the inverter, and control the high-voltage tank to generate high-voltage to excite the X-ray tube inside to emit X-rays, control the switch of the collimator

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indicator, and monitor the working status of the device, and control the display of the status indicators. The system is for X-ray imaging and diagnosis in medical facilities with mobile or fixed sites. The iQFlex Pro is not intended for mammography. Detectors are recommended but not provided with the iQFlex system. Detectors chosen must have been cleared by FDA have reasonable MTF and DQE values. The iQFlex Pro is not a cybersecurity device, however it has firmware and a USB-C port. The USB-C port is for battery charging only. The iQFlex Pro generator doesn't connect to the Internet, to other medical devices, and the supporting software doesn't offer a protocol for transfer of medical data.

1. INDICATIONS FOR USE. The iQFlex Pro Mobile X-ray System is a medical device intended for use by a qualified/trained physician or technician for handheld diagnostic imaging of body extremities The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device may be used for stand mounted imaging of the chest - Not to be used on bariatric patients, unless imaging body extremities. Not for mammography use. Not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.

The comparison between the overall specifications of predicate device (MinXray TR90BH) and the subject device (iQFlex Pro) is shown in Table 1.

Item	Predicate Device MinXray TR90BH(K182207)	Subject Device iQFlex Pro (without digitalimaging)
IntendedUse:	The TR90BH is a portable X-ray system withfollowing limitations of use: The device maybe used for handheld diagnostic imaging ofbody extremities The device may be used forstand mounted diagnostic imaging of head,abdomen, or extremities. The device maybe used for stand mounted imaging of thechest when used without a grid. - Not to beused on bariatric patients, unless imagingbody extremities. – Not for mammographyuse. - The TR90BH is not intended to replacea stationary radiographic system, which maybe required for full optimization of imagequality and radiation exposure for differentexam types	The iQFlex Pro Mobile X-ray System is a medicaldevice intended for use by a qualified/trainedphysician or technician for handheld diagnosticimaging of body extremities The device may beused for stand mounted diagnostic imaging ofhead, abdomen, or extremities. The devicemay be used for stand mounted imaging of thechest. - Not to be used on bariatric patients,unless imaging body extremities. Not formammography use. Not intended to replace astationary radiographic system, which may berequired for full optimization of image qualityand radiation exposure for different examtypes.SAME INDICATIONS
Weight	7.5 kg	5.4 kg (11.9 lbs) LIGHTER
Size	219 x 442 x 190 (mm)	274 x 227 x 186 (mm) SMALLER SIZE
EnergySource	Lithium-Ion Rechargeable Battery,57.6VDC	Lithium-Ion Rechargeable Battery,14.4Vdc/6700mAh(4S2P)
Output	20mA @ 40 ~ 60kVDC(2kVp steps) 15mA @ 62 ~80kVDC (2kVp steps) 10mA@ 82 ~ 90kVDC (2kVpsteps) High Power Mode15mA @ 82 ~ 90kVDC (2kVp steps)	50kVp ~ 80kVp, 20mA, 0.4mAs ~ 3.2mAs50kVp ~ 80kVp, 15mA, 4mAs ~ 40mAs81kVp ~ 90kVp, 16mA, 0.4mAs ~ 3.2mAs81kVp ~ 90kVp, 10mA, 4mAs ~ 32mAs91kVp ~ 100kVp, 16mA, 0.4mAs ~ 3.2mAs91kVp ~ 100kVp, 10mA, 4mAs ~ 16mAsSLIGHTLY HIGHER CAPABILITY
Item	Predicate Device MinXray TR90BH(K182207)	Subject Device iQFlex Pro (without digitalimaging)
UserInterface	Up-Down pushbuttons for kVpselections and exposure timeselections with LED indicatorsmAs indicator	Up/Down pushbuttons for kV/exposuretime(mAs) selections and LED indicatorsfor selectedkVp/exposure time(mAs)SIMILAR
Exposuretime	0.01~~1.00sec, 0.01sec stepHigh Power Mode0.01~~0.3sec, 0.01sec step	0.02~4.00sec: 0.02, 0.03, 0.04, 0.05, 0.06,0.08, 0.10, 0.13, 0.16, 0.20, 0.40, 0.50, 0.63,0.80, 1.0,1.30, 1.60, 2.00, 2.50, 3.20, 4.00sec(21 steps) SIMILAR
MemorySettings	10 memories	5 memories
HFGenerator	High Frequency	High Frequency SAME
kW	1.35kW	1.6kW SLIGHTLY HIGHER
kV	40~90kV	50~100kV SLIGHTLY HIGHER
X-ray Tube	Canon D-0814, 0.8mm, 16degree, kJ	CEI OX/100, 1.0mm, 16degree, 14kJ
Collimator	Mikasa BLD34L	FSI Manual Type, Double Slit
Photo	Image: Yellow portable x-ray machine	Image: Front view of portable x-ray machineImage: Back view of portable x-ray machine

Table 1. Comparison of Technology Characteristics

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7) Performance Testing:

The iQFlex Pro was tested to and conforms to the following standards:

US FDA Radiation Safety Performance Standard, Sec. 21CFR1020.30 Diagnostic x-ray systems and their major components

IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized

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with relevant US national differences applied FDA RECOGNITION NUMBER 19-49 IEC 60601-1-2:2014/A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements FDA RECOGNITION NUMBER 19-36

IEC 60601-1-3 Edition 2.1 2013-04 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment FDA RECOGNITION 12-269

IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013, IEC 60601-1-6:2010/AMD2:2020, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability FDA #5-132

60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy FDA RECOGNITION 12-317

Consulted Guidance: IEC TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems FDA RECOGNITION 19-19

Discussion of Testing

The performance characteristics and operation / usability of the iQFlex Pro were evaluated in nonclinical (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 requirements. Non-clinical test results have demonstrated that the device conforms to its specifications. Predefined acceptance criteria were met and test results have demonstrated 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 iQFlex Pro Mobile X-ray System in compliance to IEC 60601-1:2005/AMD1:2012 and IEC 60601-1-2:2014 – Medical electrical equipment Part 1-2, Electromagnetic Compatibility. EMC Testing was performed for both Class B environments.
. 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 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.

· Management of Cybersecurity

There is a USB-C port on the device, but it is used only for battery charging, so no Internet connection possible. This is not a cybersecurity device even though it has firmware and a USB-C port.

· Image Quality Evaluation

Test images of the head, chest, abdomen, and extremities in order to assure that diagnostic quality imaging can be obtained using this generator. The images were evaluated by a Board

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Certified Radiologist and were found to be of excellent diagnostic quality.

Clinical Studies: A limited clinical test was performed to demonstrate that the device could image 8) anatomy other than extremities. A Board Certified Radiologist performed a successful review.
CONCLUSION: After analyzing bench and clinical image tests, it is the conclusion of First Source 9) Inc. that the iQFlex Pro Mobile X-ray System is as safe and effective as the predicate device, has the same indications for use, has few technological differences, which are addressed through performance testing and compliance with the standards listed above, 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.