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The VIVA combo RF System is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.

The VIVA combo RF System consists of RF generator, active electrode, grounding pad and peristaltic pump for electrode cooling. This device is designed to produce local tissue heating at the tip of the electrodes causing the coagulation of tissue. The VIVA combo RF System is capable of delivering up to 200 W of RF power and the available power is limited through software control. This system monitors the power, resistance, current and temperature.

The active electrodes are a sterile, single-use, hand-held electrosurgical instrument designed for use with VIVA combo RF System. Cooling of the electrode is provided by chilled water which is pumped through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the water is not to be in contact with the patient.

The VIVA combo RF system consists of S VCS F, MRFALogger and VIVALogger software.

The S_VCS_F software continuously monitors impedance, current, power and temperature. The unit automatically monitors rises in impedance and adjust RF output accordingly.

MRFALogger software can be stored and monitored on PC the RF output parameter (power, impedance, current, temperature and energy).

VIVALogger software can be stored and monitored on a tablet PC the RF output parameter (power, impedance, current, temperature and energy).

The VIVA combo RF System is an electrosurgical device intended for percutaneous and intraoperative coagulation and ablation of tissue. This submission describes modifications to a previously cleared predicate device (K163450).

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

The document does not explicitly list "acceptance criteria" in a quantitative table for device performance. Instead, it details that the modified device was tested to ensure compliance with relevant medical device standards, and that these tests demonstrated the device meets design specifications and is safe and effective.

2. Sample sized used for the test set and the data provenance

The document does not specify a "test set" in terms of patient data or specific samples for clinical performance. The studies performed were non-clinical bench tests and engineering validations on the device itself. Therefore, concepts like sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable in the context of this device's evaluation, as no human or animal subject data was generated for the safety and effectiveness testing described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No ground truth was established by experts in the context of clinical or diagnostic performance for this electrosurgical device as no clinical studies were performed. The "ground truth" for the non-clinical tests was defined by the requirements of the international and FDA-recognized consensus standards.

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

Not applicable. No adjudication method was used as there was no test set involving human interpretation or clinical outcomes to adjudicate.

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 an electrosurgical system, not an AI-assisted diagnostic tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are not relevant.

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

Not applicable. This device is an electrosurgical system, not a standalone algorithm. The software components are integral to the device's operation and are not standalone "algorithms" in the sense of AI or diagnostic interpretation.

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

For the non-clinical tests performed, the "ground truth" was based on the requirements and specifications mandated by recognized international and FDA consensus standards:

• IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
• IEC 60601-2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment.
• IEC 60601-1-2: Collateral standard for electromagnetic compatibility.
• AAMI ANSI ES60601-1: Harmonized standard for electrical safety.
• FDA guidance "The content of premarket submissions for software contained in medical devices": For software validation.

8. The sample size for the training set

Not applicable. As a medical device that performs electrosurgical procedures, there is no "training set" in the context of machine learning or AI algorithm development. The device design and safety/performance are based on engineering principles and compliance with standards.

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

Not applicable, as there is no training set for this device in the context of machine learning.

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