(183 days)
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.
| 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.
§ 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.