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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 and ablation of tissue. 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. VIVA combo RF System consists of S_VCS_F, MRFALogger and STAR Logger. 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 or tablet the RF output parameter (power, impedance, current, temperature and energy). STAR Logger can be stored and monitored on a tablet PC the RF output parameter (power, impedance, current, temperature and energy).

The provided text describes a 510(k) premarket notification for the "VIVA combo RF System". This submission is for an electrosurgical cutting and coagulation device, and the specific change for which this 510(k) is submitted is the replacement of the "VIVA Logger" software with "STAR Logger" for using a tablet with the device.

Based on the document, here's what we can extract regarding acceptance criteria and the study:

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

The document does not provide a table of acceptance criteria with reported device performance. It states that "Software verification and validation was conducted on the changed to VIVA combo RF System software to validate it for its intended use per the design documentation in line with recommendations outlined in General Principles of Software Validation, Guidance for Industry and FDA staff." It further states, "The VIVA combo RF System demonstrated passing results on all applicable testing."

This indicates that internal acceptance criteria were met, but the specific metrics and their corresponding performance values are not detailed in this summary. The assessment appears to be focused on functional equivalence and safety rather than a comparative performance study against specific, quantified acceptance thresholds for clinical efficacy using data.

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify a "test set" in the context of clinical data. The "testing" mentioned refers to software verification and validation, which is typically conducted on the software itself and the integrated system, not a data set of patient cases.
• Data Provenance: Not applicable, as no clinical data or test sets derived from patient data are mentioned for the software validation.

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 establishment for a test set of clinical data is mentioned, as the study is a software verification and validation, not a clinical performance study.

4. Adjudication method for the test set:

Not applicable. There's no mention of a test set requiring adjudication in the context of clinical interpretation or diagnosis.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were considered necessary and performed." This means there's no comparison of human readers with or without AI assistance.

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

The software's function is to "display certain data that is also shown on the VIVA combo RF Generator" and to "store and monitor... RF output parameter (power, impedance, current, temperature and energy)." It continuously monitors these parameters and adjusts RF output. While this is algorithmic behavior, the document does not describe a standalone "performance" study in the sense of a diagnostic algorithm's accuracy as it is an operational control and monitoring software. The "performance" assessment was for its functional correctness and safety, ensuring it behaves as intended and doesn't introduce new risks.

7. The type of ground truth used:

Not applicable in the conventional sense of clinical ground truth (e.g., pathology, expert consensus). The "ground truth" for this software validation would be the functional requirements and design specifications. The software was validated against these specifications to ensure it accurately monitors and displays the intended parameters and maintains safety.

8. The sample size for the training set:

Not applicable. This is not an AI/ML product developed with a training set of data. It's software for controlling and monitoring an electrosurgical device.

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

Not applicable, as no training set was used.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria was a software verification and validation process. This process was conducted on the changed software (STAR Logger) to ensure it performs its intended function safely and effectively within the VIVA combo RF System.

• Acceptance Criteria (Implicit): The implicit acceptance criteria were that the "STAR Logger" software would accurately display and store the RF output parameters (power, impedance, current, temperature, energy) and communicate correctly with the VIVA combo RF generator without introducing new safety or effectiveness concerns. These criteria were derived from the device's design documentation and aligned with general software validation guidance from the FDA.
• Reported Device Performance: The document states, "The VIVA combo RF System demonstrated passing results on all applicable testing." This implies that the software met all pre-defined functional and safety requirements during verification and validation.
• Safety and Risk Assessment: A risk assessment was conducted, evaluating compliance with FDA-recognized consensus standards for medical device software (ANSI AAMI ISO 14971, IEC 62304, IEC TIR80002-1). This confirms that the altered software does not pose new or increased risks.
• Nature of the Change: The change was specifically replacing the "VIVA Logger" software with "STAR Logger" to enable tablet use with a new UI. The core technological characteristics and indications for use of the VIVA combo RF system itself remained unchanged.
• No Clinical Studies: No clinical studies were deemed necessary because the software change was considered minor and did not impact the fundamental safety or effectiveness of the device's therapeutic action. The change was related to user interface and data display/storage for operational parameters.

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