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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 is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

The Viveve 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 consists of four (4) primary components: An RF Generator to provide the heating energy. The Generator incorporates the Cooling Module to supply the coolant which provides the cooling energy. A hand piece that couples the cooling and heating energy to the tissue through the treatment tip (below). A footswitch that allows the user to turn the RF Energy on or off. 5 cm and 8cm Sterile Disposable Treatment Tips. Accessories include: Coupling Fluid, Cryogen, Return Cable, Return Pad, Power Cord.

The provided document is a 510(k) summary for the Viveve RF System, Secure (K180584). It states that the device is substantially equivalent to a previously cleared predicate device (Viveve System, K162547). The primary change in the subject device is the addition of an 8 cm Treatment Tip, while the predicate device only had a 5 cm Treatment Tip.

Based on the provided text, the acceptance criteria and the study proving the device meets them are described in the context of demonstrating substantial equivalence to a predicate device.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of quantitative acceptance criteria or specific performance metrics in the way one might expect for a new, novel device. Instead, the acceptance criteria are implicitly met by demonstrating that the modifications (the new 8cm tip) do not adversely affect safety, efficacy, or performance compared to the predicate device.

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

• Sample Size: Not specified in terms of clinical test subjects. The testing was primarily non-clinical (bench testing). For the specific non-clinical tests (e.g., electrical safety, EMC, biocompatibility), the sample sizes for components tested are not detailed but are assumed to be sufficient for the standard.
• Data Provenance: The testing was "design verification bench testing" and "biocompatibility testing." This is laboratory-based testing, not clinical data from patients. No country of origin for clinical data is applicable as no clinical data was used for substantial equivalence. The document states, "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence as the only change was to the length of the Treatment Tip shell, all internal components are identical."

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

• Not applicable. This was a non-clinical submission relying on engineering and laboratory testing against established standards and design specifications, not expert interpretation of diagnostic images or clinical scenarios.

4. Adjudication method for the test set:

• Not applicable. This was not a study requiring adjudication of expert interpretations. Results from technical tests (e.g., PASS/FAIL for standard compliance, measurement within specification) are objective.

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 submission concerns an electrosurgical device, not an AI-powered diagnostic tool. No MRMC studies were conducted.

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

• Not applicable. This is not an AI algorithm. The mention of "Software validation" refers to internal software controlling the device's operational parameters, not a standalone diagnostic algorithm.

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

• The ground truth for the non-clinical tests was adherence to established international standards (IEC 60601 series, ISO 10993-1, ISO 14972) and the device's design specifications and performance requirements.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device requiring a training set.

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

• Not applicable. No training set was used.

Ask a specific question about this device

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

The Viveve 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 consists of four (4) primary components:

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

Accessories include:

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

This document is a 510(k) premarket notification for the Viveve System, an electrosurgical device. It primarily focuses on demonstrating substantial equivalence to a predicate device due to design modifications rather than presenting a study to prove new acceptance criteria or performance claims.

Here's an analysis of the provided text in relation to your questions:

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

The document does not explicitly provide a table of acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic output. Instead, it discusses demonstrating conformity to safety and performance standards for an electrosurgical device.

The "reported device performance" is essentially that the device continues to meet these standards and design parameters after modifications. It doesn't present new performance data for a diagnostic task.

Here’s a summary based on the provided text, reinterpreting "acceptance criteria" as conformity to relevant standards and "reported device performance" as confirmation of that conformity:

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

The document primarily describes non-clinical performance data (bench testing, software validation, biocompatibility) rather than a clinical test set with patient data. Therefore, the concept of "sample size" in the context of patients, "country of origin," or "retrospective/prospective" study design is not applicable here.

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)

This information is not provided as the submission relies on non-clinical performance data (engineering tests, standard compliance) rather than expert-adjudicated clinical data to establish ground truth for a diagnostic task.

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

This information is not applicable as the document describes non-clinical engineering and safety testing, not a clinical study involving human judgment and adjudication for a test set.

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, an MRMC comparative effectiveness study was not done. This device is an electrosurgical cutting and coagulation device, not an AI-powered diagnostic tool, so this type of study is irrelevant to its purpose.

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

This information is not applicable. The Viveve System is an electrosurgical device, not an algorithm or AI product. Its performance is evaluated through its physical and electrical characteristics as determined by engineering tests, not a standalone algorithm.

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

For the non-clinical performance data, the "ground truth" essentially comes from:

• Industry and regulatory standards: (e.g., IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, ISO 10993-1, ISO 14972).
• Design specifications and performance requirements: The device's components and system are tested against their defined technical specifications and operational parameters.
• Predicate device characteristics: The modified device is compared to the previously cleared predicate device to ensure substantial equivalence.

8. The sample size for the training set

This information is not applicable. The Viveve System is not an AI/ML device that requires a training set.

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

This information is not applicable, as there is no training set for this device.

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