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The Veinwave/TC3000 system is intended for epilation, and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.

The Veinwave/TC3000 system consists of a power generator and a needle through which a controlled dose of radio frequency energy is delivered and is intended for epilation, and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.

The provided text is a 510(k) summary for the Veinwave/TC3000 device. While it details the device's technical characteristics and its substantial equivalence to predicate devices, it does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria.

The document states: "The information discussed above demonstrates that the Veinwave/TC3000 device is substantially equivalent to the predicate devices." This implies that the demonstration of substantial equivalence serves as the primary basis for market clearance, rather than a specific performance study with predefined acceptance criteria. Clinical studies with detailed methodology and results are not typically required for 510(k) submissions when substantial equivalence can be demonstrated through other means (e.g., comparison of technical characteristics, safety and performance testing to established standards).

Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or details on MRMC and standalone studies, as this information is not present in the provided 510(k) summary.

In summary, the document does not provide the requested information regarding acceptance criteria and studies demonstrating their fulfillment.

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