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The VIVACE Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. This Vivace Electrosurgical System is intended for use with Skin Type I to Skin Type V.

Device Description

The VIVACE Electrosurgical System is comprised of the following components: the system main body of the device which consists of the LCD touch screen control panel, the high frequency generating output section (main P.C.B board or RF Generator), and the power supply component, the Switching Power Supply (SMPS). The accessories to the device include the handpiece with disposable micro-need le cartridge (electrode) insertion, and foot switch. Radio frequency current (RF energy) is delivered from the RF Generator, through the handpiece and electrode tip into the target tissue. The hand piece being held at right angles, the tip is placed in light contact with the epidermis. As RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating (causing minor dermal damage) the tissue. The bi-polar RF energy is delivered between independent adjacent electrode pairs (total 36 needle electrode, 6 x 6 array insertion). The RF generator, hand piece are not disposable. Each disposable micro-needle cartridge (electrode) is supplied sterile and is for single patient use only and cannot be resterilized.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the VIVACE Electrosurgical System based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Clinical Efficacy (Wrinkle Improvement)	Among 3 blinded evaluators, by 2/3 evaluator agreement (≥ 1 point change) criteria, 17 out of 28 (60.7%) subjects had one point improvement at 90-day follow-up using the Fitzpatrick Wrinkle and Elastosis Scale. The device showed moderate, but positive improvement in wrinkle severity and elastosis damage.
Clinical Safety (Adverse Events)	Adverse Events that occurred in greater than 5% of subjects were Erythema (77.42%), Edema (19.35%), Edema (16.13%), and Sensitivity (6.45%). Adverse event cases decreased with each re-treatment phase for all AE types and were resolved within 24 hours. Overall adverse event rates were highest at the first treatment cycle (70.97%) and decreased significantly by the third treatment cycle (6.45%).
Pain Level	Most patients felt less pain overall through 3 treatment cycles. At the 1st treatment cycle, 9/28 (32%) experienced pain at level 1-3, 12/28 (43%) at level 4-6, and 7/28 (25%) at level 7-10. During the 3rd treatment cycle, 15/28 (53%) reported pain at levels 1-3, 12/28 (43%) at levels 4-6, and 1/28 (3.5%) at levels over 8.
Electrical Safety	Electrical safety tests were completed. (Specific acceptance thresholds are not provided in the summary).
Electromagnetic Compatibility	Electromagnetic compatibility tests were completed. (Specific acceptance thresholds are not provided in the summary).
Sterility	Micro-needle cartridge is supplied sterile and sterility conforms to a Sterility Assurance Level (SAL) of 10⁻⁶.
Biocompatibility	Biocompatibility studies of all patient contact materials were performed in accordance with ISO 10993-1.
No new safety/effectiveness issues	There are no new safety or effectiveness issues related to this device.
Overall Safety and Effectiveness	The VIVACE Electrosurgical System is safe and effective for its intended use. The clinical study demonstrates that the VIVACE functions as intended with no significant impact on the safety and effectiveness profile of the device.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Clinical Study): 31 participants were enrolled, with 28 subjects completing all three sessions and included in the final study analysis.
Data Provenance: The study was a "31 patient US study," indicating the data was collected in the United States and was prospective as it involved tracking subjects over time after treatment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Three, blinded, independent licensed physicians.
Qualifications: "Licensed physicians" is the only qualification explicitly stated. No specific experience level (e.g., "radiologist with 10 years of experience") is provided.

4. Adjudication Method for the Test Set

Adjudication Method: "By 2/3 evaluator agreement (≥ 1 point change) criteria." This means that for a subject to be considered to have improved, at least two out of the three blinded evaluators had to agree on at least a one-point improvement on the score.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not reported in this summary. The study focused on the device's standalone clinical efficacy.

6. Standalone (Algorithm Only) Performance Study

This device is an electrosurgical system, not an AI algorithm. Therefore, a standalone (algorithm only without human-in-the-loop performance) study in the context of AI is not applicable. The clinical study described evaluates the device's performance when used by clinicians.

7. Type of Ground Truth Used

Clinical Ground Truth: Expert consensus of three blinded physicians using a validated clinical scoring methodology (9-point Fitzpatrick Wrinkle and Elastosis Scale).

8. Sample Size for the Training Set

Not Applicable / Not Provided: This device is a medical instrument (electrosurgical system), not an AI algorithm that requires a training set in the typical sense. The summary describes a clinical study to validate the device's performance, not to train a predictive model.

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

Not Applicable / Not Provided: As in point 8, this is not an AI algorithm with a training set. The "ground truth" (clinical outcomes) described in the performance section was established by expert evaluation.

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