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The D'RF Digital Dynamic Remote System Is indicated for use in generating fluoroscopic Images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.

D'RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Canon Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography and is detachable and portable for direct projections to create a unique and highly versatile 3-in-1 imaging solution. The receptor panel directly converts the X-ray Images captured by the LANMIT (Large Area New MIS Sensor and TFT) sensor into a high-resolution digital Images. The instrument is suited for use inside a patient environment. This unit converts the X-rays into digital signals. The unit can acquire still and moving images. The system includes a remotely controlled tilting/elevating table.

The provided document is a 510(k) summary for a Digital Fluoroscopic X-Ray System (D'RF Digital Dynamic Remote System). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of acceptance criteria and device performance in the manner requested.

Here's a breakdown of the information that can be extracted and what is explicitly not mentioned in the summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not provide a table of acceptance criteria with specific quantitative metrics or reported device performance data in the way a clinical study would.
Instead, it broadly states:

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

This information is not provided in the 510(k) summary. The document mentions "Performance testing" but does not detail the size or nature of any test set (e.g., number of patients, images, or phantom studies). There is no mention of data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the 510(k) summary. Given the nature of a substantial equivalence submission for fundamental X-ray technology, a clinical study involving expert ground truth might not be a primary requirement for this type of device.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size

An MRMC study is not mentioned in the 510(k) summary. The focus is on demonstrating equivalence to the predicate, not necessarily comparative effectiveness with human readers.

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

This concept is not applicable in the context of this device. The D'RF Digital Dynamic Remote System is a physical X-ray imaging system, not an AI algorithm. Its "performance" refers to the quality of the images it generates and its operational characteristics, which are ultimately interpreted by a human.

7. The type of ground truth used

This information is not provided as there is no detailed study described. For X-ray imaging systems, "ground truth" often relates to image quality metrics (e.g., spatial resolution, contrast-to-noise ratio) measured using phantoms, rather than clinical outcomes or pathology from patient data for a diagnostic algorithm.

8. The Sample Size for the Training Set

This information is not applicable as the D'RF Digital Dynamic Remote System is a physical X-ray imaging system, not a machine learning model that requires a training set.

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

This information is not applicable for the reasons stated in point 8.

In summary:

The provided 510(k) summary for the D'RF Digital Dynamic Remote System focuses on demonstrating substantial equivalence to a predicate device (Canon Dynamic/Static DR Model URS-50RF Fluoroscopic Digital X-Ray System K093688). It broadly states that the device's technological characteristics are "equal to or better than" the predicate and that it is "safe and effective."

The document does not contain the detailed clinical study information, specific acceptance criteria with quantitative metrics, sample sizes, expert ground truth details, or MRMC study results that your request is looking for. These types of detailed performance studies are more common for novel diagnostic algorithms or devices with highly specific quantitative performance claims, rather than for a new iteration of a well-established imaging modality like an X-ray system seeking substantial equivalence. The "performance testing" mentioned likely refers to engineering and quality control tests to ensure the system meets its specifications and regulatory standards, rather than a clinical trial with patient ground truth.

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