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The VFSS Pro Mobile system is intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device. The device provides fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside of hospital, in a variety of procedures of the skull, spinal column, chest, abdomen, extremities, and at the medical professional the device may be used for other imaging applications on all patients except neonates (birth to one month) within the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications.

The VFSS Pro™ Mobile system is intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device provides fluoroscopic imaging and is used for guidance and visualization during routine fluoroscopic and image-guided procedures. The device is to be used in professional healthcare facilities, in a variety of image-guided procedures such as feeding tube and catheter insertion on pediatric patients except neonates (birth to one month). This device is not indicated for large/obese patients or interventional use. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications.

The VFSS Pro Mobile system is a mobile imaging system that can acquire, process, and display fluoroscopic images. It can be easily positioned within a room and moved from room within a facility. To provide the ability to perform fluoroscopic examinations as needed within a facility. The system employs a low-powered mono-block generator and a dynamic flat-panel detector so that it can be powered through a single-phase 120VAC power outlet. The imaging chain is powered by the Insight Agile DRF Digital Imaging System which allows the operator to view and enhance high-definition fluoroscopy images up to 30 fps. Images may be viewed and enhanced enabling the operator to bring out diagnostic difficult or impossible to see using conventional imaging techniques. Images can be stored locally for short term storage. The Insight Agile DRF Digital Imaging System enables the operator to produce hardcopy images with a laser printer or send images over a network for longer-term storage. The major system components include: a dynamic flat panel detector, monitors, and an image processor PC. This device employs either the Vieworks FXDD-1212G or the Rayence 1212FCA digital x-ray receptor panels (previously cleared, see Reference devices). The device software employed is from the Reference device Insight Agile DRF.

The provided text describes a 510(k) premarket notification for a medical device, the VFSS Pro Mobile Digital Imaging System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new level of clinical effectiveness or safety through extensive clinical trials as might be required for a PMA (Premarket Approval) device.

Therefore, the study conducted is primarily focused on non-clinical bench testing to demonstrate that the new device performs similarly and is as safe and effective as the predicate device. It does not involve clinical studies with human patients or AI-powered diagnostic algorithms that would require the specific acceptance criteria and study design elements typically found in AI/CADe (Computer-Assisted Detection/Diagnosis) device submissions (e.g., sensitivity, specificity, MRMC studies, expert ground truth adjudication).

Here's a breakdown based on the information provided, addressing the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission based on non-clinical testing, the "acceptance criteria" are primarily established against the performance of the legally marketed predicate device and relevant industry standards. The reported device performance is comparative.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable in the traditional sense of a clinical test set with patient data. The "test set" here refers to the bench testing for hardware, software, electrical, mechanical, and radiation safety. This would involve specific setup configurations and phantoms in a lab environment. The document does not specify the number of phantom images or specific test runs; it only states that "phantom images were acquired" and "bench testing was performed."
• Data Provenance: Not applicable as clinical patient data was not used. The testing was laboratory/bench-based.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not applicable. For this type of submission, "ground truth" relates to measurable physical parameters (e.g., radiation output, image quality metrics on phantoms, electrical safety measurements) compared to pre-defined standards or the predicate device's measured performance. There were no human expert interpretations for image diagnostic accuracy needed.
• Qualifications of Experts: The testing was performed by "Imaging Engineering" and the overall submission prepared by IMAGExRAY, LLC's "Principal Engineer." These are engineering and technical experts, not clinical experts for diagnostic accuracy.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As there were no human readers interpreting images for diagnostic accuracy, no adjudication method (e.g., 2+1, 3+1) was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission explicitly states "No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification. Bench testing was performed to assess the device safety and effectiveness." This indicates that human reader performance with or without AI assistance was not evaluated.

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

• Standalone Performance: Not applicable. The device is an imaging system, not an AI or algorithm-only device intended for standalone diagnostic assessment. Its performance is evaluated as an integrated system for image acquisition and display. There is no mention of a diagnostic algorithm within the device that would require a standalone performance study.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this submission is based on:
  • Engineering specifications and measurements: Comparing the device's measured performance (e.g., power output, image acquisition frames per second, pixel characteristics) against its own specifications and the predicate device's known characteristics.
  • Compliance with recognized industry standards: The device's ability to pass tests for electrical safety (IEC 60601 series), radiation control (21 CFR 1020.32), and software/cybersecurity guidance.
  • Phantom image analysis: Comparing the quality and characteristics of images produced using phantoms to those from the predicate device.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is not an AI/ML model that undergoes a "training" phase with a dataset. It's a hardware and software system for image acquisition.

9. How the Ground Truth for the Training Set was Established

• Training Set Ground Truth Establishment: Not applicable, as there is no AI/ML training set.

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