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The Venclose™ Radiofrequency System (Generator and Catheters) is intended for use in endovascular coagulation of blood vessels in patients with superficial vein reflux.

The Venclose RF System is composed of two basic components: an energy console or generator (digiRF) and catheters (EVSRF) designed specifically to be used with the generator. The Venclose RF System uses resistive radiofrequency ablation via energy delivery to heat the wall of an incompetent vein with temperature-controlled RF energy to cause irreversible luminal occlusion, followed by fibrosis and ultimately resorption of the vein. The blood then naturally reroutes to healthy veins.

The technique involves percutaneous access and insertion of the EVSRF Catheter into the great saphenous vein (GSV) or other superficial vein under ultrasound guidance, injection of local anesthesia, and thermal energy from a radiofrequency generator (digiRF) applied into the target vein. As the EVSRF Catheter is withdrawn stepwise down the treated length of the vein, thermal damage is inflicted upon the venous endothelium and through the vein wall, resulting in contraction and ultimately destruction of the vessel. The procedure can be performed in an outpatient setting, without the need for general anesthesia, allowing for a walkin/walk-out procedure with minimal postoperative recovery time.

I am sorry, but the provided text does not contain detailed acceptance criteria or a specific study that proves the device meets those criteria in the format requested. The document is a 510(k) summary for the Venclose™ Radiofrequency System, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance metrics against specific acceptance criteria.

While it mentions non-clinical bench testing and pre-clinical animal testing, it does not provide:

• A table of acceptance criteria with reported device performance.
• Sample sizes for a test set or data provenance for specific performance evaluation.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm-only) performance.
• Specific ground truth types used for detailed performance evaluation.
• Sample size for a training set or how its ground truth was established, as this is not an AI/algorithm-based device in the context of typical AI performance studies.

The document primarily focuses on:

• Device Description: What the Venclose RF System is and how it works.
• Materials: Composition of the console and catheters.
• Comparative Summary of Technological Characteristics: A table comparing the subject device with predicate devices in terms of features like energy/frequency, maximum output power, dimensions, etc., to establish similarity.
• Non-Clinical Testing: A general statement that testing was conducted to evaluate conformance to product specifications and applicable standards (e.g., ISO 10555-1, IEC 60601-1). It lists types of bench tests (Catheter Simulation, Temperature, Pressure, Tensile, Fluid Test) but does not provide specific acceptance values or results for these tests.
• Pre-clinical testing (Animal Study): Describes the purpose (demonstrate proper functionality), the model used, and objectives (insertion, navigation, reaching/holding temperature, vein diameter reduction). It concludes that "All of the objectives were met resulting in a satisfactory study conclusion," but again, it doesn't provide quantitative acceptance criteria or specific performance data from this study.
• Rationale for Substantial Equivalence: Concludes that the non-clinical and animal testing demonstrates the Venclose System is as safe, effective, and performs at least as safely and effectively as the predicate devices.

In summary, the provided text establishes substantial equivalence for regulatory purposes but does not offer the detailed performance data against explicit acceptance criteria that your request asks for, especially in the context of an AI-driven device performance study.

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