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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.

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.

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.

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.

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The iQFlex M/iQFlex MD Mobile X-ray System is a medical device intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities). This device is not intended for mammography.

This Mobile X-ray System (Model: i9Flex M/iºFlex MD) consists of a LED display with up and down soft-keys for controlling kV, an X-ray generator (linepowered transformer), an X-ray tube assembly, and a collimator. A cart or a stand can be used with the iºFlex MD. In addition, this unit has preset memory keys to store and select kV/mAs, The iQFlex M/iQFlex MD is used with a film-cassette or flat-panel detector. The image detectors (a necessary component of a fully-functional diagnostic system) are not part of this submission. This device is a mains-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, control panel, system control board, high-voltage tank, inverter, collimator (beam limiter), and system control software running on the system control 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 control panel. The user can adjust and control the kV 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 system control board, and control the highvoltage tank to generate high-voltage to excite the X-ray tube inside to emit Xrays, 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 facilities with mobile or fixing sites. The iQFlex M/iºFlex MD is not intended for mammography. The device can be used with an X-ray flat panel detector, a computer for receiving and detecting signal results and an image processing software. This mobile X-ray system is designed for handheld or stand-mounted imaging. Model i®Flex MD can be configured to an optional portable stand that complies with IEC 60601- 1 safety standard. The recommended maximum load that the stand can safely carry is 30kgs to ensure the mechanical stability and effectiveness of the device. The cybersecurity risks of the i9Flex M/iºFlex MD have been addressed to assure that no new or increased cybersecurity risks were introduced as a part of device risk analysis. These risks are defined as sequence of events leading to a hazardous situation, and the controls for these risks were treated and implemented as proposed in the risk analysis (e.g., requirements, verification).

The provided text is a 510(k) Summary for the iQFlex M/iQFlex MD Mobile X-ray System. It describes the device, its indications for use, comparison to a predicate device, and performance data. However, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the way you've outlined.

Specifically, it states "Clinical Studies: Not applicable. Clinical testing was not deemed to be required to show substantial equivalence. We relied on non-clinical testing and compliance with standards." This means:

• No clinical study was performed to evaluate the device's performance in a clinical setting against specific acceptance criteria related to diagnostic accuracy or clinical outcomes.
• The entire submission relies on non-clinical (bench) testing and compliance with recognized standards (electrical safety, EMC, software, cybersecurity) to demonstrate substantial equivalence to a predicate device.

Therefore, I cannot populate the requested table and information, as the study as described in your prompt (especially regarding human readers, ground truth, and clinical performance metrics) was not conducted or reported in this document.

For completeness, here's what could be inferred about "acceptance criteria" from the provided text, but it's not in the format you requested, nor does it address clinical performance:

Summary of "Acceptance Criteria" (based on non-clinical testing and standards compliance):

Since no clinical study was performed, the following information cannot be provided from the text:

1. Sample size used for the test set and data provenance: Not applicable, no clinical test set.
2. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
3. Adjudication method for the test set: Not applicable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, and effect size of improvement with AI vs without AI assistance: Not applicable, no clinical study or AI component mentioned.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no algorithm performance study was mentioned.
6. The type of ground truth used: Not applicable, no clinical ground truth established.
7. The sample size for the training set: Not applicable, no machine learning training details provided.
8. How the ground truth for the training set was established: Not applicable.

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