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The NFLK-2501 Portable X-ray Unit is a portable X-ray 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).

The device may be used for handheld diagnostic imaging of body extremities.

The system is subject to the following limitations of use when stand-mounted:

• The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities.
• The device may be used for imaging of the chest when used without a grid.

This device is not intended for mammography.

The NFLK-2501 consists of a LED display with up and down soft-keys for controlling kV, an X-ray generator (line-powered transformer), an X-ray tube assembly, a collimator. A cart or a stand can be used with the NFLK-2501. In addition, this unit has preset memory keys to store and select kV. The NFLK-2501 is used with a flat-panel detector.

This device is a mains-powered Mobile X-ray System, designed and manufactured by NEUF.

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 (SYS) board, high-voltage tank, collimator (beam limiter), and system control software running on the SYS board. The system control software is for realtime 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 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 facilities with mobile or fixing sites.

This device 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. The NFLK-2501 is designed for handheld or stand-mounted imaging. The NFLK-2501 can be configured to an optional portable stand/rack (see optional stands in 4.2) or use a 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 NFLK-2501 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 FDA 510(k) summary for the NFLK-2501 Portable X-ray Unit primarily focuses on establishing substantial equivalence to a predicate device through technological comparison and compliance with electrical safety and performance standards. It does not present acceptance criteria or a study proving the device meets specific clinical performance criteria in the way typically seen for AI/ML-based devices.

The document is for a traditional X-ray unit, not an AI-powered diagnostic device. Therefore, the types of acceptance criteria and studies anticipated for AI/ML devices (e.g., sensitivity, specificity, AUC, MRMC studies) are not applicable or detailed here.

Instead, the "acceptance criteria" can be inferred from the non-clinical testing performed, which focuses on device safety, electrical performance, and compliance with general X-ray standards to demonstrate substantial equivalence.

Here's the information based on the provided document, interpreting "acceptance criteria" as compliance with relevant standards and "study" as the non-clinical testing performed:

Acceptance Criteria and Study for NFLK-2501 Portable X-ray Unit

The NFLK-2501 Portable X-ray Unit is a traditional X-ray device, and its acceptance criteria are primarily based on demonstrating substantial equivalence to a predicate device and compliance with established electrical safety, performance, and radiation protection standards. The "study" refers to the non-clinical bench testing conducted to meet these standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

This is a traditional X-ray unit, not an AI/ML diagnostic device that relies on a "test set" of images or patient data for performance evaluation. The "testing" involved non-clinical bench tests to verify compliance with electrical, mechanical, and radiation safety standards. Therefore, the concept of a "sample size for a test set" and "data provenance" in the context of clinical performance data is not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As this is not an AI/ML diagnostic device with a clinical "test set" requiring ground truth establishment, no experts were involved in this capacity. The "ground truth" for the device's acceptable performance is defined by compliance with the referenced industry and regulatory standards.

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

Not applicable for the reasons stated above.

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

Not applicable. This device is a portable X-ray unit, which is a hardware device for image acquisition, not an AI/ML-driven diagnostic aid for image interpretation. Therefore, no MRMC study comparing human readers with and without AI assistance was performed.

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

Not applicable. This device is an X-ray imaging system, not an algorithm, and does not have a standalone "algorithm-only" performance to evaluate.

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

The "ground truth" in this context is the successful demonstration of compliance with established international medical device standards (e.g., IEC 60601 series) and FDA regulations (21 CFR 1020). These standards define acceptable levels of safety, electrical performance, and radiation characteristics for X-ray equipment. It is not based on clinical "ground truth" such as pathology or outcomes data for diagnostic accuracy, as this is an imaging device, not a diagnostic algorithm.

8. The sample size for the training set

Not applicable. The device is a hardware X-ray machine, not an AI/ML model trained on a dataset.

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

Not applicable for the reasons stated above.

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