(62 days)
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):
| Acceptance Criteria Category | Reported Device Performance (as per non-clinical testing and standards compliance) |
|---|---|
| Electrical Safety | Conforms to IEC 60601-1:2005/AMD1:2012, EN 60601-1:2006/A1:2013 |
| Electromagnetic Compatibility (EMC) | Conforms to IEC 60601-1-2:2014 / EN60601-1-2:2015 |
| Radiation Protection | Conforms to EN 60601-1-3:2008/A11:2016 |
| X-ray Equipment Basic Safety & Essential Performance | Conforms to IEC 60601-2-54:2015/EN 60601-2-54:2015 |
| Software Life-Cycle Processes | Conforms to IEC 62304:2006/AMD1:2015. Software verification and validation conducted (considered "moderate" level of concern). |
| Usability Engineering | Conforms to IEC 62366-1:2015/EN 62366:2008 AMD1:2015 and IEC 60601-1-6:2010+A1:2013 |
| Risk Management | Conforms to ISO 14971:2012 |
| Cybersecurity | Management of cybersecurity implemented as per FDA guidance (Oct 2, 2014); risks addressed to assure no new or increased risks. |
| Overall Performance & Functionality | "Intended workflow, related performance, overall function, shipping performance, verification and validation of requirements for intended use, and reliability of the system including both software and hardware requirements" were evaluated in non-clinical (bench) testing. Predefined acceptance criteria were met. |
| Substantial Equivalence | Device is as safe and effective as the predicate device (MinXray HF120/60HPowerPlus™), has the same indications for use, and technological differences are addressed through performance testing and standards compliance. |
Since no clinical study was performed, the following information cannot be provided from the text:
- Sample size used for the test set and data provenance: Not applicable, no clinical test set.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no algorithm performance study was mentioned.
- The type of ground truth used: Not applicable, no clinical ground truth established.
- The sample size for the training set: Not applicable, no machine learning training details provided.
- How the ground truth for the training set was established: Not applicable.
§ 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.