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The TOPA 12 Portable X-Ray Unit is intended for use by a qualified/trained doctor or technician on adult subjects for taking diagnostic radiographic exposures for acquiring X-ray images of the desired parts of patient anatomy of extremities.

This portable radiographic unit (Model: TOPA12) 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 TOPA12. In addition, this unit has preset memory keys to store and select kV, The TOPA12 is used with a film-cassette or flatpanel detector.

This device is a mains-powered portable X-ray unit, 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 real-time interaction and control with various circuit modules inside the portable X-ray unit. 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.

Since the kV range of this device is 40~90kVp, which is not suitable for breast exams, the 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. This portable X-ray unit is designed for handheld or stand-mounted imaging. This portable X-ray unit can be configured to an optional portable stand/rack 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 provided text is a 510(k) summary for the TOPA12 Portable X-ray Unit. It outlines the device's indications for use, comparison with a predicate device, and performance data. However, it explicitly states:

"Clinical studies were not performed."

Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on clinical performance. The acceptance criteria and performance data provided are based on non-clinical testing and conformity to various electrical and safety standards.

Here's the information that can be extracted from the provided text regarding acceptance criteria and performance, as well as the limitations for your request:

1. A table of acceptance criteria and the reported device performance
   • Since no clinical studies were performed, there are no acceptance criteria related to diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) based on expert review of clinical images.
   • The "reported device performance" in this document is primarily in relation to meeting recognized electrical, safety, and radiation protection standards, and a qualitative clinician review of sample images.

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

   • No clinical test set was used. The document mentions "Sample clinical images of extremities (Elbow, Hand, Knee, Ankle, Foot) were reviewed by a qualified clinician." The exact number of samples is not provided, nor is the data provenance (country, retrospective/prospective). This was likely a qualitative review for technical image quality rather than a diagnostic performance study.

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)

   • "a qualified clinician" reviewed the sample images. The exact number of clinicians or their specific qualifications (e.g., specialty, years of experience) are not provided. Given the nature of the review (qualitative assessment of image quality), this was not a ground truth establishment for diagnostic performance.

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

   • Not applicable, as no formal diagnostic performance test set with adjudication was described. Only a single "qualified clinician" is mentioned for reviewing sample images.

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

   • No MRMC study was performed. The device is an X-ray unit, not an AI-powered diagnostic tool. The document states, "Clinical studies were not performed."

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

   • Not applicable. The device is a portable X-ray unit for image acquisition, not a standalone diagnostic algorithm.

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

   • Not applicable for diagnostic performance, as no clinical study for diagnostic performance was conducted. For the qualitative review of sample images, the "ground truth" was implicitly the judgment of a "qualified clinician" regarding image quality and clinical utility.

8. The sample size for the training set

   • Not applicable, as this is an X-ray imaging device, not an AI/CADe/CADx algorithm requiring a training set in the conventional sense.

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

   • Not applicable, as there is no training set mentioned in the context of an AI algorithm.

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