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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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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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The VIVA combo RF Ablation 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.

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 generator 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 provided document is a 510(k) summary for the STARmed VIVA Combo RF System. It details the device's characteristics, intended use, and comparison to a predicate device.

However, it explicitly states:

"No clinical studies were considered necessary and performed."

This means that the document does not contain information on acceptance criteria for device performance based on a clinical study or a study proving that the device meets such criteria. The acceptance criteria and performance data provided are based on non-clinical bench tests and compliance with electrical safety and EMC standards.

Therefore, I cannot provide a response filling in all the requested sections regarding clinical study performance, human expert involvement, ground truth, or MRMC studies, as these types of studies were not conducted for this device's 510(k) submission.

Here is what can be extracted from the document regarding the acceptance criteria and non-clinical performance:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for non-clinical bench testing.
• Data Provenance: Non-clinical bench tests, likely performed at the manufacturer's facility in Republic of Korea.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as no clinical studies with expert-established ground truth were performed.

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

• Not applicable as no clinical studies requiring adjudication were performed.

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

• No MRMC or human-in-the-loop studies were conducted. The device is not an AI/software as a medical device (SaMD) that typically relies on such studies.

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

• No standalone algorithm performance study was done in a clinical context. The device is electrosurgical hardware, not an AI algorithm.

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

• For non-clinical tests, "ground truth" would be the established engineering specifications, published standards (e.g., AAMI, IEC), and internal validation protocols for software, biocompatibility, and sterilization.

8. The sample size for the training set

• Not applicable, as there is no indication of machine learning or AI models with training sets being part of this device or its submission.

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

• Not applicable.

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