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The Viveve 2.0 System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

The Viveve 2.0 System utilizes monopolar radiofrequency (RF) energy to selectively heat a given volume of tissue beneath the surface, while cryogen is delivered to the inside of the treatment tip to cool the surface tissue. The generator delivers energy to the treatment tip to create an electric field under the treatment tip (electrode). The mechanism of action is the application of RF energy to the tissue causing coagulation and/or hemostasis.

The Viveve® 2.0 System consists of four (4) primary components:

• . An RF Generator to provide the heating energy. The Generator incorporates the Cooling Module to supply coolant which provides the cooling energy.
• . A hand piece that couples the cooling and heating energy to the tissue through the treatment tip.
• A footswitch that allows the user to turn the RF Energy on or off.
• 5cm or 8cm Sterile Disposable Treatment Tips.

Accessories include:

• . Coupling Fluid
• Cryogen ●
• Return Cable ●
• Return Pad ●
• . Power Cord

This document, K213814, is a 510(k) premarket notification for the Viveve 2.0 System. It describes a change in the manufacturing site from Sparton Medical to Spartronics for the Viveve 2.0 System.

Based on the provided text, there is no detailed study information regarding acceptance criteria and device performance as typically expected for demonstrating clinical efficacy or algorithm performance. This submission is primarily about a manufacturing site change and asserts that because no other aspects of the device have changed, the performance remains the same as the predicate device. Therefore, many of the requested details about studies are not present in this document.

However, I can extract the relevant information that is available and explain why other sections are not applicable.

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

This document does not provide a table of acceptance criteria and reported device performance in the context of clinical efficacy or algorithm performance. The core assertion of this 510(k) is that the device (Viveve 2.0 System) is substantially equivalent to its predicate device (Viveve 2.0 System, K212678) because only the manufacturing site has changed, and no other aspects of the device, software, or indications for use have been altered.

Therefore, the "acceptance criteria" here implicitly refer to demonstrating that the device produced by the new manufacturer maintains the same specifications and quality as the previous manufacturer, ensuring it performs identically to the predicate device.

Implicit Acceptance Criteria (for the manufacturing change):

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

Not applicable. This 510(k) does not describe a test set or data provenance in the context of evaluating the clinical performance or accuracy of the device itself. The "performance data" mentioned refers to "Design verification testing, including bench performance and software verification/validation" to demonstrate substantial equivalence, rather than a clinical study with a patient test set.

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 this 510(k) is focused on a manufacturing site change and substantial equivalence without clinical efficacy studies, there's no mention of experts establishing ground truth for a test set.

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

Not applicable. There is no described test set or clinical study requiring an adjudication method.

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. The Viveve 2.0 System is an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic or therapeutic system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device or its submission.

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

Not applicable. The Viveve 2.0 System is a physical medical device (RF generator, handpiece, etc.) used in general surgical procedures. It does not operate as a standalone algorithm.

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

Not applicable. No ground truth in the context of clinical data or algorithm performance is described in this submission. The "performance data" mentioned refers to "Design verification testing" (e.g., bench testing, software validation) to ensure the device manufactured at the new site meets pre-defined engineering and safety specifications, consistent with the predicate device.

8. The sample size for the training set

Not applicable. As there are no clinical studies or AI algorithms being evaluated in this submission, there is no training set to report.

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

Not applicable. As above, there is no training set mentioned in this submission.

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The Viveve 2.0 System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

The Viveve® 2.0 System consists of four (4) primary components:

• . An RF Generator to provide the heating energy. The Generator incorporates the Cooling Module to supply coolant which provides the cooling energy.
• . A hand piece that couples the cooling and heating energy to the tissue through the treatment tip.
• A footswitch that allows the user to turn the RF Energy on or off.
• . 5cm or 8cm Sterile Disposable Treatment Tips.

Accessories include:

• Coupling Fluid
• Cryogen ●
• Return Cable ●
• Return Pad ●
• . Power Cord

The provided document describes the Viveve 2.0 System, an electrosurgical device that delivers radiofrequency energy. The primary change in this 510(k) submission (K193611) compared to its predicate device (K190422) is the addition of Contact Quality Monitoring (CQM) software and a modified user interface. The study focuses on demonstrating the safety and effectiveness of this added feature.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a specific "test set" in terms of patient data. The testing described for the CQM and software validation was performed on the device itself, likely using phantom tissue (pork belly) for functional tests of the return pad contact. The data provenance is internal testing performed by Viveve and by contract manufacturer Sparton Medical, as well as third-party testing by Intertek. There is no information about country of origin of data or whether it was retrospective or prospective, as it's not a clinical study on human subjects but rather device verification and validation.

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

Not applicable. The ground truth for this device modification is based on engineering specifications and compliance with established electrical safety and software validation standards, not expert clinical interpretation of data. The "ground truth" is that the device correctly identifies and reports contact quality and disables RF output when necessary.

4. Adjudication method for the test set

Not applicable. This was device verification and validation against engineering specifications and international standards, not a clinical study requiring adjudication of expert interpretations.

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

No. This document does not describe an MRMC comparative effectiveness study. The submission is for a modification to an electrosurgical device, specifically related to a safety feature (Contact Quality Monitoring). It does not involve human readers interpreting medical images or data from an AI system.

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

Yes, in a sense. The testing described for the CQM feature and software verification is a standalone evaluation of the algorithm's performance in monitoring contact and issuing alerts or disabling RF output. There is no mention of a "human-in-the-loop performance" study described in this document for the specific change being cleared. The device's safety mechanisms (like CQM) are designed to operate automatically.

7. The type of ground truth used

The ground truth used for this submission is based on:

• Engineering specifications and design requirements: The device's expected behavior and performance characteristics (e.g., resistance range, response time for CQM).
• International standards conformance: Compliance with established electrical safety and electromagnetic compatibility standards (e.g., AAMI ES60601-1, IEC 60601-1-6, IEC 60601-2-2, IEC 60601-1-2).
• Functional validation against known states: Demonstrating that the system responds correctly to scenarios like adequate vs. inadequate return pad contact using phantom tissue.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set of data. The "software" in question is for Contact Quality Monitoring, a rules-based or algorithmic safety feature, not a learning algorithm.

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

Not applicable, as there is no training set for an AI/ML algorithm in this context.

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