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The VNUS Radiofrequency Generator is intended for use with VNUS radiofrequency devices intended for vessel and tissue coagulation.

The VNUS RF Generator, model RFG2 is a bipolar, high frequency electronic, microprocessor and software controlled instrument. It allows the user to set Power, Temperature and Time (Set-points and measured values) as well as measured impedance and user messages. It is provided non-sterile. The model RFG2 is compatible only with the disposable RF delivery devices (e.g., catheters) marketed by VNUS Medical Technologies under separate clearance(s). The instrument cable connects the disposable device to the RF generator. The Instrument Cable is provided non-sterile and is user sterilizable by autoclave. It has been validated to eliminate multiple steam sterilization cycles. If the disposable device has an integrated cable, a separate instrument cable is not necessary.

The provided 510(k) notification for the VNUS Radiofrequency Generator, Model RFG2, does not include detailed acceptance criteria or a comprehensive study demonstrating direct quantitative performance against such criteria in the way a modern AI/device submission would. Instead, it relies on substantial equivalence to predicate devices and general performance claims based on in-vitro testing.

Here's a breakdown of the information that can and cannot be extracted from the provided document, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Limitations from the document:

• The document does not provide specific, quantitative acceptance criteria for metrics like accuracy, sensitivity, specificity, or objective performance benchmarks.
• The "reported device performance" are general statements that the device is "safe and effective" and "substantially equivalent." There are no numerical results or performance statistics presented.
• The document mentions "in-vitro testing" but does not provide any details about the methodology, results, or how these results specifically demonstrate safety and effectiveness against explicit criteria.

Given the nature of this submission (a 510(k) from 2004 for an electrosurgical generator, focusing on substantial equivalence), much of the requested information regarding AI-specific studies, ground truth establishment, expert adjudication, and large-scale clinical trials in the context of diagnostic/AI performance is not applicable or present in this document.

Here's an assessment of the other requested information based on the document:

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

• Sample Size: Not applicable/not specified. The document refers to "in-vitro testing" but provides no details on sample size, types of samples, or specific tests conducted. This is not a study involving a "test set" of patient data in the way an AI algorithm would be evaluated.
• Data Provenance: Not applicable. The "testing" mentioned is in-vitro, meaning likely bench testing or laboratory experiments, not patient data from a specific country or collected retrospectively/prospectively.

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

• Not applicable. This device is an electrosurgical generator, not a diagnostic imaging or AI device that requires expert-established ground truth for a test set. The validation would likely involve engineering and electrical performance testing.

4. Adjudication Method for the Test Set

• Not applicable. There is no mention of a "test set" or adjudication in the context of expert review for this device.

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. This is not an AI device. Therefore, no MRMC study comparing human readers with and without AI assistance was performed or reported.

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

• Not applicable. This device is an electrosurgical generator, not an algorithm. Its operation inherently involves a human operator.

7. The Type of Ground Truth Used

• Not applicable in the context of clinical "ground truth" (e.g., pathology, outcomes data). For an electrosurgical generator, "ground truth" for performance would be based on engineering specifications, electrical safety standards, and functional performance in in-vitro models (e.g., tissue impedance, temperature control, power output). The document states "Results of in-vitro testing will demonstrate that the VNUS Radiofrequency Generator is safe and effective."

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI algorithm that requires a "training set" in the machine learning sense.

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

• Not applicable. As this is not an AI device, there is no training set or ground truth establishment relevant to machine learning.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document states: "Results of in-vitro testing will demonstrate that the VNUS Radiofrequency Generator is safe and effective for its intended use." It further concludes based on "the design, materials, functioning performed by VNUS" and "comparison with currently marketed devices" that the device is "substantially equivalent to predicate devices in safety and effectiveness."

Key points regarding the "study":

• The "study" is described as in-vitro testing. No details about the specific tests, methodologies, or results are provided in this summary.
• The primary mechanism for demonstrating compliance is substantial equivalence to previously cleared predicate devices (VNUS RF Generator models RF-110 and RF-220, cleared under K0033547). This means the device relies on demonstrating that it is as safe and effective as a legally marketed device, often by showing it has the same technological characteristics, intended use, and performs similarly in relevant (often non-clinical) tests.
• The document implies that the in-vitro testing would have assessed factors like the generator's ability to deliver bipolar RF energy, maintain set power/temperature, and operate safely, consistent with the technological characteristics and principle of operation of the predicate devices.

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