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The RFX Fluoroscopic digital imaging system is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed.

The RFX fluoroscopic digital imaging system allows the use of digital imaging to be applied to conventional X-ray system used in general fluoroscopy, interventional fluoroscopy, angiography and cardiac imaging areas. The system works by installing a CCD camera on the output port of the imaging intensifier and digitizing the video output of the image intensifier. The digital image can be displayed on the monitor; it can be stored to the hard drive, or sent to an external device such as a laser imager or Dicom Network Service Provider. The image can also be processed, including brightness and contrast, edge enhancement, zoom, and subtraction.

The provided text is a 510(k) summary for the RFX Fluoroscopic Digital Imaging System. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not include detailed information regarding specific acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth methodologies that would typically demonstrate a device meets acceptance criteria.

The purpose of a 510(k) summary is to demonstrate substantial equivalence to a legally marketed predicate device, rather than providing a detailed clinical study report with specific performance metrics and acceptance criteria. Therefore, the requested information, particularly quantitative data on acceptance criteria and study design, is largely absent from this document.

Below is a response attempting to extract as much relevant information as possible from the provided text, while also noting what is missing.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The provided 510(k) summary for the RFX Fluoroscopic Digital Imaging System focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study with specific acceptance criteria and performance metrics. Therefore, explicit acceptance criteria and a study design proving the device meets those criteria are not detailed in this document.

Instead, the summary asserts that the RFX system offers "virtually all of the features" offered by the predicate devices, implying that its performance would be comparable and therefore acceptable for its intended use. The "Conclusion drawn from comparison" states: "The RFX fluoroscopy digital imaging system can be considered to be substantially equivalent to: INFIMED Inc. GOLDONE Fluoroscopic System (510K) ~ K963037 CMT Medical Technologies. SPOT / RAD System (510K), K991578 and K003434 and, virtually all of the features offered by the predicate devices are offered by the RFX product."

The core "acceptance" here is the FDA's determination of substantial equivalence, which is typically based on comparing the new device's technological characteristics, intended use, and performance claims to those of a legally marketed predicate device. The document does not contain a specific study proving it meets quantitative acceptance criteria beyond this equivalence claim.

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative acceptance criteria are not explicitly stated in the document, a table cannot be fully constructed. The document's primary "performance claim" is its equivalence in features and intended use to predicate devices.

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

This information is not provided in the 510(k) summary. The document does not describe a specific "test set" of data used for performance evaluation. The comparison is primarily based on device specifications and intended use against predicate devices.

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

This information is not provided. No expert involvement in establishing ground truth for a test set is mentioned.

4. Adjudication Method for the Test Set

This information is not provided. No test set or related adjudication method is described.

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

No MRMC study is mentioned in the document.

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

The RFX system is described as a digital imaging system that assists a human operator by digitizing, displaying, and enhancing fluoroscopic images. It is not an "algorithm only" device in the sense of making independent diagnostic decisions. Its performance is inherently tied to human use and interpretation. No standalone performance study, as typically understood for AI algorithms, is mentioned.

7. The Type of Ground Truth Used

This information is not provided. The document does not describe any specific ground truth used for evaluation. The "ground truth" for a 510(k) submission like this is often regulatory compliance and substantial equivalence to established predicate devices, rather than clinical outcomes or pathology for novel diagnostic claims.

8. The Sample Size for the Training Set

This information is not provided. The document does not describe any machine learning or AI components that would require a "training set."

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

This information is not provided, as no training set is mentioned.

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