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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 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 resulting in 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 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.

The Viveve treatment tips contained in this package are a sterile single use component of the Viveve® System and designed to deliver radiofrequency (RF) energy from the Viveve console. The Viveve treatment tips can only be used in conjunction with the dedicated Viveve® System.

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. The submission primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a de novo clinical study with new acceptance criteria.

Therefore, the specific information requested regarding acceptance criteria, a study proving the device meets these criteria, sample sizes, expert involvement, ground truth establishment, and MRMC studies is not explicitly presented in the provided text in the way one would expect for a novel device undergoing clinical validation against pre-defined performance metrics.

Instead, the submission argues for substantial equivalence based on:

• Identical Indications for Use: "The Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis." (Page 2, 4)
• Identical Technological Characteristics: "The technological characteristics of the subject device Viveve System are identical to those of the predicate devices, Viveve System (K180584) and Viveve 2.0 System (K190422)." (Page 4)
• Identical Principle of Operation: "The principle of operation between the predicate devices and the subject device remain identical as do all output parameters to tissue." (Page 4)
• Minimal Design Modifications: The changes are limited to packaging of the sterile treatment tip, and a software modification to extend the useful life of the handpiece (from 11,000 to 65,000 pulses). This software change was "validated and assessed for additional risk to the patient and was deemed non-significant." (Page 5)
• Change in Contract Manufacturer and Sterilizer: Cirtec Medical is now the sole contract manufacturer for the treatment tips, and STERIS will be the contract sterilizer. (Page 6)
• Performance Data (Design Verification Testing): "Design verification testing, including bench performance, electrical safety/electromagnetic compatibility, software verification/validation, packaging and shelf-life studies, provided in the subject premarket notification demonstrate that the Viveve System is substantially equivalent to the predicate device, Viveve System." (Page 7)

In summary, this 510(k) does not detail a study proving the device meets new acceptance criteria. Instead, it asserts equivalence to predicate devices that have already met their respective regulatory requirements.

Given this context, I cannot directly fill in the table or answer all sub-questions as they pertain to a new, primary clinical validation study. However, I can infer and state what is available:

Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence Argument):

Detailed Responses to Specific Questions (based on provided text):

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

   • See the table above, which outlines the implicit acceptance criteria based on the substantial equivalence argument and the reported performance as stated in the document.

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

   • The provided text does not describe a clinical test set in the sense of patient data for a comparative study. This submission relies on substantial equivalence.
   • The "test set" described relates to design verification testing (bench performance, electrical safety/EMC, software V&V, packaging, shelf-life). The specific sample sizes for these engineering tests are not detailed in this summary document, as is typical for a 510(k) summary (full reports would be in the complete submission).
   • Data Provenance: Not applicable for clinical study data. For engineering tests, it's generally laboratory data from the manufacturer or contracted labs.

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

   • This question is not applicable as there is no mention of a clinical test set requiring expert ground truth establishment (e.g., for image interpretation). The evaluation is based on engineering equivalence and design verification.

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

   • This question is not applicable as there is no clinical test set requiring adjudication of findings (e.g., in an image interpretation study).

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 conducted or described. This device is an electrosurgical system, not an AI diagnostic/assistive tool for human readers.

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

   • Not applicable. This device is hardware and software for direct patient treatment, not a standalone diagnostic algorithm.

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

   • Not applicable in the context of clinical ground truth for a diagnostic device. For the engineering tests, the ground truth would be the established performance specifications and validated test methods.

8. The sample size for the training set:

   • Not applicable. This document does not describe the development of a machine learning algorithm with a training set. The software changes concern extending the handpiece lifespan, which was validated through engineering tests, not machine learning training.

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

   • Not applicable for the same reasons as point 8.

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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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