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The VNUS® Closure™ System is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

The VNUS Closure System consists of three main components: The VNUS Closure Catheter, the VNUS RF Generator and the VNUS Instrument Cable. The Closure Catheter is provided sterile, and is a single-use, disposable device. The RF Generator is non-sterile. The Instrument Cable is autoclave sterilized by the user. An optional Footswitch for RF ON/RF OFF is provided for use at the physician's discretion.

The RF Generator is a high frequency (460kHz) electronic, bipolar, microprocessor / software controlled instrument. It allows the user to set Power, Temperature and Time values, and provides user displays of Power, Temperature and Time (setpoints and measured values) as well as measured Impedance and user messages. Audible tones provide additional feedback to the physician. The RF Generator acts to maintain the set temperature by requlating the power delivered up to the maximum set power. By doing so, the RF Generator controls the temperature at the tip of the catheter.

The Closure Catheter is used to provide RF energy to the desired treatment site and relay temperature feedback to the RF Generator. It is designed to deliver the RF energy in a bipolar manner.

The Instrument Cable is used to connect the Closure Catheter to the RF Generator.

The provided text describes the VNUS® Closure™ System and its submission for 510(k) clearance, asserting substantial equivalence to predicate devices. However, it does not contain a detailed study with specific acceptance criteria, reported device performance metrics, or information about sample sizes, expert involvement, or adjudication methods for a clinical trial.

Instead, the document states:

• Discussion of Clinical/Non-Clinical Tests and Conclusions H. Clinical/Non-Clinical tests performed by VNUS have demonstrated the substantially equivalent performance of the Closure System with predicate electrosurgery systems used for substantially equivalent indications.
• Summary of Safety and Effectiveness i. Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by VNUS, it is concluded that the Closure System is substantially equivalent to the noted predicate devices in safety and effectiveness.

This indicates that while non-clinical tests were conducted to demonstrate substantial equivalence, the document does not provide the specific details of those tests. It does not present quantifiable acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, or specific clinical outcomes), nor does it report detailed device performance against such criteria.

Therefore, I cannot populate the table or answer most of the specific questions regarding a clinical study from the provided text.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

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

• Sample Size for Test Set: Not mentioned in the provided text.
• Data Provenance: Not mentioned in the provided text.

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)

• Not mentioned in the provided text.

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

• Not mentioned in the provided text.

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

• Not mentioned in the provided text. The document refers to "non-clinical testing" and not specifically to a clinical comparative effectiveness study involving human readers or AI.

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

• Not mentioned in the provided text. The device described is a medical instrument (electrosurgery system), not an AI algorithm.

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

• Not mentioned in the provided text, as specific clinical or non-clinical test details are absent.

8. The sample size for the training set

• Not applicable/Not mentioned. The device is a hardware system, not an AI algorithm requiring a training set in the conventional sense.

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

• Not applicable/Not mentioned.

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