(24 days)
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:
| Acceptance Criteria Category (Reinterpreted) | Reported Device Performance |
|---|---|
| Safety and Essential Performance Standards | Met acceptance criteria, confirming continued conformance to IEC 60601-1:2005 (2006/07-3rd edition) and IEC 60601-2-2:2009. |
| Electromagnetic Compatibility (EMC) Standards | Met acceptance criteria, confirming continued conformance to IEC 60601-1-2:2007. |
| Design Parameters (for Proposed Modifications) | Design verification bench testing and software validation ensured the proposed modifications perform within design parameters and under proper environmental conditions. Results met acceptance criteria. |
| Biocompatibility Standards | Biocompatibility testing for the Treatment Tip and Coupling Fluid (parts with patient contact) was performed according to ISO 10993-1:2009. The results met acceptance criteria. |
| Risk Analysis Standards | Risk analysis was completed in accordance with criteria based on ISO 14972:2007. |
| Sterilization (Method and Parameters) | Remains the same as the predicate device. |
| Shelf Life (Treatment Tips) & Packaging Validation | Treatment Tips shelf life was tested and verified to extend to three years. Packaging validation testing was completed. |
| System Functionality, Safety, or Effectiveness (Overall) | The modifications had "no effect on system functionality, safety, or effectivity," and the "results of performance testing demonstrate that the modifications to the Viveve System do not affect the safety, efficacy, or performance of the generator." The device continues to be "substantially equivalent" to the predicate. |
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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.