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The VIVACE Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis and the percutaneous treatment of facial wrinkles for use with Fitzpatrick Skin Type I to Skin Type V when using the 1MHz setting. The 2MHz setting has not been evaluated for use in the percutaneous treatment of facial wrinkles and is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The VIVACE Electrosurgical System is comprised of the following components:

• . The system main body, consisting of:
  • LCD touch screen control panel O
  • High-frequency generating output section (main P.C.B board or RF Generator) O
  • Power supply component Switch Mode Power Supply (SMPS) O
• The accessories to the device include: ●
  • Handpiece with Handpiece Connector o
  • Disposable micro-needle cartridge (electrode) for insertion into Handpiece O
  • Foot switch O
    Radio frequency current (RF energy) is delivered from the RF Generator, through the handpiece and electrode tip into the target tissue. As RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating (causing minor dermal damage) the tissue. The bi-polar RF energy is delivered between independent adjacent electrode pairs (total 36 needle electrode, 6 x 6 array insertion). The RF generator and hand piece are not disposable micro-needle cartridge (electrode) is supplied sterile and is for single patient use only and cannot be re-sterilized.

The provided text is a 510(k) Summary for the VIVACE Electrosurgical System. It outlines the device's technical specifications and the performance data submitted to the FDA to establish its safety and efficacy and demonstrate substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets them in the context of an AI/ML medical device, which is what your request implies.

The "Performance Data" section (Page 6 of the input) lists various tests that were conducted (electrical testing, biocompatibility testing, sterility testing, shelf life/packaging, software verification/validation, and thermal testing) and states that "All acceptance criteria were met." However, it does not define these acceptance criteria, nor does it provide detailed results or specific studies that you've requested (e.g., MRMC studies, sample sizes for test/training sets, expert qualifications, ground truth establishment methods for AI/ML performance studies).

The "Thermal Testing" section briefly mentions:

• An ex vivo animal study using a porcine tissue model.
• Standardized H&E staining techniques to visualize and measure thermally damaged profile data through Nitro Blue Tetra Chlorine (NBTC) and H&E histological evaluation.
• The finding that the vivace microneedling device showed consistent formation of measurable thermal lesions for highest energy level settings in the treatment porcine tissue at a temperature close to physiological.

This is a performance test, not a study to establish clinical effectiveness or compare AI performance against a human or a human-assisted AI.

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and the study proving the device meets them as described in your prompt (which is structured for an AI/ML device performance study) because this regulatory document for the VIVACE Electrosurgical System does not contain such information. It focuses on demonstrating substantial equivalence through engineering and biological performance testing, not AI model performance.

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