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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 System and Viveve 2.0 System are 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® System and Viveve® 2.0 System consist 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 return pad is the subject of this submission. Previously, Viveve specified and supplied the user with the 3M model 9160 electrosurgical return pad. Viveve is seeking to add additional return pad options for the user with the following characteristics:

• United States FDA clearance
• A split pad with no cord attached.
• Conducted area is between 40 cm2 and 120 cm2.
• Measured impedance between 20-140 ohms.

This document, a 510(k) Summary for the Viveve System and Viveve 2.0 System (K212678), describes a device that has been found substantially equivalent to a predicate device, focusing on a change related to the electrosurgical return pads. This is not a typical AI/ML medical device submission where acceptance criteria are based on diagnostic performance metrics (e.g., sensitivity, specificity, AUC) and proven through reader studies or standalone algorithm performance.

Instead, this submission is for an electrosurgical cutting and coagulation device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the technical and safety performance requirements for the new component (return pads) and how their equivalence to the original component was demonstrated.

Here's an analysis based on the provided document, addressing your questions where applicable given the nature of this submission:

Device Description:
The Viveve System and Viveve 2.0 System are electrosurgical devices utilizing monopolar radiofrequency (RF) energy for electrocoagulation and hemostasis, with cryogenic cooling of the surface tissue.

Purpose of this Submission (K212678):
The primary change in this 510(k) submission is the addition of new, compatible electrosurgical return pad options. Previously, the system specified and supplied the 3M model 9160 return pad, which became unavailable. This submission seeks to allow the use of any US FDA-cleared split return pad meeting specific characteristics.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are the specifications for the new return pads, and the "reported device performance" is the manufacturer's claim of equivalence based on testing.

Important Note: The "study" proving acceptance criteria here is not a clinical trial or reader study in the conventional sense of AI/ML devices. It's a design verification and bench testing effort to demonstrate functional equivalence and safety of the new components with the existing system. The document explicitly states: "Viveve has performed testing on three similar return pads. The testing revealed that the pads with the above specifications perform equivalent to each other when used with both the Viveve System and Viveve 2.0 System."

Study Details (as inferable from the document)

Given that this is a 510(k) for a change in an accessory (return pad) for an electrosurgical device, many of the questions related to AI/ML device performance studies (like MRMC, ground truth establishment by experts, training set details) are not applicable or are addressed indirectly through the concept of "substantial equivalence" and bench testing.

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

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

   • Test Set (for the return pads): The document states "Viveve has performed testing on three similar return pads." This indicates a sample size of 3 different return pads (brands/models) were tested to establish equivalence.
   • Data Provenance: The testing was "performed by Viveve" (implies in-house or by a contracted lab for design verification). This is not retrospective/prospective data from human subjects or clinical outcomes, but rather engineering/bench testing data. The country of origin of the data is not explicitly stated but is implicitly within the regulatory framework of the US FDA submission process.

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

   • Not applicable in the typical AI/ML sense. Ground truth for an electrosurgical device's accessory performance is established through engineering specifications, international standards (e.g., IEC 60601 for electrical safety), and bench testing protocols. The "experts" would be the engineers and technicians performing the design verification and assessing compliance with established performance parameters (e.g., RF energy delivery, temperature profiles, impedance). No external clinical experts are mentioned for establishing "ground truth" related to this specific change.

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

   • Not applicable. This relates to clinical expert consensus for challenging cases in diagnostic AI studies. Here, the "adjudication" is based on objective measurements and comparison against established performance specifications for electrosurgical accessories.

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. This is not an AI-assisted diagnostic device. The study is a technical verification that changes in a physical component (return pads) do not adversely affect the safety and fundamental performance of the electrosurgical system.

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

   • No. This is an electrosurgical medical device, not an algorithm. The performance evaluated is the physical and electrical function of the device with the new return pads.

7. The type of ground truth used:

   • Engineering/Bench Test Data and Compliance with Standards. The ground truth is the demonstration that the "new" return pads, when used with the Viveve System, maintain the same safe and effective performance characteristics as the original specified pad. This is demonstrated through design verification testing, including electrical safety/electromagnetic compatibility, and software verification/validation (for the overall system, which remained unchanged). The key is demonstrating functional equivalence and safety.

8. The sample size for the training set:

   • Not applicable. This is not a machine learning device that requires a "training set."

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

   • Not applicable.

Conclusion from the Document:
The submission concludes that the design, technical characteristics, functionality, indications for use, and principle of operation of the Viveve system remain unchanged. The addition of compatible return pads "do not raise questions of safety or efficacy of the overall system." Therefore, the Viveve System and Viveve 2.0 System are deemed substantially equivalent to the predicate devices.

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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

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