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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.

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