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The VNUS RFS and RFSFlex devices are intended for use in vessel and tissue coagulation including: Treatment of incompetent (i.e., refluxing) perforator and tributary veins.

The VNUS RFS family of devices is a bipolar, high frequency electrosurgical system designed for use in general surgical procedures where blood vessel and tissue coagulation is desired. These devices are compatible with separately cleared Radiofrequency (RF) Generator, and the Instrument Cable manufactured by VNUS Medical Technologies. The VNUS RFS family of devices are sterile disposable devices intended for a singleuse only. The device's function is to deliver bipolar RF energy to the desired treatment site and relay temperature and other feedback to the RF Generator. The disposable device is available in 2 bipolar configurations and multiple lengths for selection by the physician based on preference for method of vessel access, location and length of the vessel to be treated. This submission reflects a name change, minor modification of the indication statement (more specific inclusion of perforator and tributary veins), and minor design changes.

The provided text indicates that the VNUS® RFS and RFSFlex Devices were evaluated for substantial equivalence to predicate devices (VNUS® Closure® System and VNUS® Vessel and Tissue Coagulation System) rather than undergoing a de novo clinical study with specific acceptance criteria and performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not present in the given document.

Here's a breakdown of the information that is available based on the provided text, and where gaps exist:

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 applicable. The submission relies on "in-vitro testing" and comparison to the "well-established history" of predicate devices, rather than a clinical test set with a defined sample size for subjects.
• Data provenance: Not explicitly stated for specific test data. The submission refers to "in-vitro testing." The predicate device's history (over 100,000 procedures) is cited as evidence of efficacy, but this is a general statement about the technology, not specific data from the device under review.

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 applicable. There is no mention of an expert panel establishing ground truth for a clinical test set in the context of this 510(k) submission.

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

• Not applicable. No clinical test set requiring adjudication is described.

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 applicable. This device is a surgical instrument (bipolar electrosurgical system), not an AI diagnostic tool that would involve human readers or AI assistance.

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

• Not applicable. This device is a surgical instrument, not an algorithm. Its "standalone" performance would relate to its physical and energetic output, as confirmed by in-vitro testing.

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

• For the "in-vitro testing," the ground truth would likely be defined by engineering specifications, physical/chemical measurements, and potentially histological analysis of treated tissue in laboratory settings. The document does not specify the exact nature of this "ground truth."
• For the claim of "well-established history of safe an efficacious use" for RF ablation/coagulation, the ground truth would be historical clinical outcomes data, morbidity, and mortality statistics associated with the predicate technology over thousands of procedures.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would require a "training set."

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

• Not applicable. There is no training set for this type of device.

In summary, this document is a 510(k) submission for "substantial equivalence," not a report of a new clinical efficacy study. Therefore, the details requested about acceptance criteria, clinical test sets, expert ground truth, and AI performance are largely absent because they are not typically part of a substantial equivalence determination for this class of medical device. The safety and effectiveness are primarily supported by in-vitro testing and the established history of the predicate devices.

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