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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 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 .

The Viveve 2.0 System is an electrosurgical device for electrocoagulation and hemostasis, receiving FDA clearance based on substantial equivalence to its predicate device, the Viveve System (K180584). The modifications in the Viveve 2.0 System primarily involve design, software, hardware, labeling, and technical/environmental specifications, but no changes that affect the fundamental mode of action or clinical use were identified.

1. Table of Acceptance Criteria & Reported Device Performance

1. Increased submucosal fibroblast activation over control levels.
2. No mucosal epithelial erosion and/or ulceration.
3. No tissue necrosis regions.
4. No granulation tissue foci.
5. No extensive or hypertrophic scar-like collagen increases. | The 90 J/cm² and 120 J/cm² treatments significantly increased fibroblast activation over baseline. This was associated with an increase in submucosal collagen in Days 30 and 90 biopsies (approximately twice that of controls). Mucosal erosion-ulceration, tissue necrosis, granulation tissue, and excessive collagen increases (hypertrophic scar-like) were not identified, fulfilling the safety criteria. The 160 J/cm² approached significant fibroblast activation, while 60 J/cm² was insufficient. |
   | Safety (GLP Study VI-OV-SAF-04) | Tissue temperatures during clinical and supra-therapeutic protocols should not cause cellular damage. Histological evaluation should confirm this. | Neither the Clinical Protocol nor the Supra-Therapeutic Protocol resulted in temperatures expected to cause cellular damage. Histological evaluation confirmed this. Maximum temperatures were well below safety concerns but within the range for desired cellular changes. Deep tissue heating (3-8mm target area) was observed without significant deposition in muscularis and dissipated rapidly. No histopathologic findings associated with RF energy administration were found. |
   | Substantial Equivalency (Non-GLP Study VI-OV-SAF-05) | Viveve 2.0 System's temperature-time profile in vaginal tissue should be substantially equivalent to the currently cleared Viveve System, and temperatures should not cause cellular damage. | The Clinical Protocol with the Viveve 2.0 System resulted in temperatures not expected to cause cellular damage and was substantially equivalent to the currently cleared Viveve System (compared to VIV-OV-SAF-04 values). Maximum temperatures were safe and within the range for desired cellular changes. Tissue temperature increases were observed in deep tissue layers (3-8mm target), with rapid dissipation in the muscularis. No profile differences indicated safety concerns. |

2. Sample Size and Data Provenance

• GLP Study IV0311g:
  • Sample Size: 25 non-nulliparous female ovine (Ovisaries) for the treatment and control groups.
  • Data Provenance: In-vivo ovine (sheep) vaginal model. The study was conducted at a single test facility, likely in the US, given the FDA submission. It is a prospective animal study.
• GLP Study VI-OV-SAF-04 (VIV-1702):
  • Sample Size: Six parous female ovine (Ovisaries).
  • Data Provenance: In-vivo ovine (sheep) vaginal model. Conducted at a single test facility, likely in the US. Prospective animal study.
• Non-GLP Study VI-OV-SAF-05 (VIV-1801):
  • Sample Size: Three parous female ovine (Ovisaries).
  • Data Provenance: In-vivo ovine (sheep) vaginal model. Conducted at a single test facility, likely in the US. Prospective animal study.

3. Number of Experts and Qualifications for Ground Truth

• GLP Study IV0311g:
  • Number of Experts: Two blinded board-certified pathologists.
  • Qualifications: Board-certified pathologists. Specific years of experience are not mentioned.

4. Adjudication Method for the Test Set

• The document describes that for GLP Study IV0311g, histological evaluation was performed by "two blinded board-certified pathologists." However, it does not explicitly state an adjudication method (e.g., 2+1, 3+1) if there were disagreements between the pathologists. The analysis likely proceeded with a consensus or reported findings from both.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. The studies were pre-clinical animal studies focused on the device's safety, efficacy, and substantial equivalence to a predicate, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• The Viveve 2.0 System is an electrosurgical device, not an AI algorithm. Therefore, no standalone (algorithm only) performance study was conducted. The performance studies described evaluate the physical device's interaction with biological tissue.

7. Type of Ground Truth Used

• Pathology: The primary ground truth for the animal studies (GLP Study IV0311g, GLP Study VI-OV-SAF-04, Non-GLP Study VI-OV-SAF-05) was based on histological evaluation of tissue biopsies. This included assessing thermal tissue injury, fibroblast activation, qualitative collagen increases, mucosal epithelial erosion, tissue necrosis, and granulation tissue foci.
• Temperature-Time Profiles: For GLP Study VI-OV-SAF-04 and Non-GLP Study VI-OV-SAF-05, direct measurement of tissue temperatures using fluoroptic temperature probes provided quantitative ground truth regarding the thermal effects of the device.

8. Sample Size for the Training Set

• These studies are pre-clinical animal studies designed for device verification and validation, as well as demonstrating substantial equivalence. They are not machine learning studies that typically involve "training sets" for algorithm development. Therefore, there is no specified training set sample size in the context of AI. The animal models serve as the "test set" for validating the device's physical performance.

9. How the Ground Truth for the Training Set Was Established

• As mentioned in point 8, there isn't a "training set" in the context of AI for this device. For the animal studies, the ground truth was established through:
  • Histopathological analysis: By two blinded board-certified pathologists examining stained tissue biopsies for specific cellular and tissue changes.
  • Direct temperature measurements: Using fluoroptic temperature probes to accurately record tissue temperatures during and after treatment.
  • Macroscopic assessment: During necropsy for gross pathological changes.

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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