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The Venus Viva™ Device is a non-invasive device intended to be used by aesthetic physicians or dermatologists.

When used with the Diamondpolar applicator, the Venus Viva™ Device is intended for use in dermatological and surgical procedures for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin type I-IV.

When used with the Viva applicator, the Venus Viva™ Device is intended for use in dermatological procedures requiring ablation and resurfacing of the skin.

The Venus Viva™ device consists of a console (main unit) and two applicators – Viva and Diamondpolar. The console contains a power supply unit, an RF generator (power module, on main board), a controller unit (on main board) and a touchscreen user interface and display panel.

The Venus Viva™ device is a combination of the previously cleared Venus Viva™ SR (K150161), the primary predicate, and the Diamondpolar applicator that was previously cleared for the secondary predicate Venus Legacy BX (K142910). Both the Viva and Diamondpolar applicators can now be connected simultaneously to a single console, the Venus Viva™ console.

The Venus Viva™ Device is a non-invasive device intended for use by aesthetic physicians or dermatologists. It is designed for dermatological and surgical procedures, specifically for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV (when used with the Diamondpolar applicator) and for ablation and resurfacing of the skin (when used with the Viva applicator).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" in a typical quantitative clinical performance metric sense (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, it focuses on demonstrating substantial equivalence to predicate devices by meeting performance standards, electrical safety, biocompatibility, and software validation. The key acceptance criteria are implicitly that the new device performs at least as well as, and has similar safety and effectiveness profiles as, the predicate devices.

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

The provided document describes engineering and laboratory performance testing, not a clinical study involving human subjects or patient data. Therefore, there is no "test set" in the context of patient data; instead, the "test set" refers to the device itself and its components undergoing various engineering evaluations.

The data provenance is laboratory testing conducted by Venus Concept USA Inc. or its designated testing facilities, likely in the country of manufacture or where the company is headquartered (USA or elsewhere as a global company). The data is generated from prospective testing of the new Venus Viva™ device against established standards and comparisons to predicate device specifications.

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

This type of information is not applicable to the submission described. The "ground truth" here is objective engineering specifications, regulatory standards (e.g., IEC standards for electrical safety), and verified characteristics of the predicate devices. These are established through established scientific and engineering principles, not through expert human interpretation of results like in a diagnostic study.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable. Adjudication methods like 2+1 (two readers agree, third adjudicates if they disagree) are relevant for clinical studies where human readers interpret data (e.g., medical images) to establish ground truth or assess performance. The tests described are objective engineering measurements and compliance evaluations.

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

There was no MRMC comparative effectiveness study and the device is not an AI/CAD (Computer-Aided Detection/Diagnosis) device. It is an electrosurgical cutting and coagulation device. Therefore, this section is not applicable.

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

This is not an algorithm-only device. It is a physical medical device (an electrosurgical unit with applicators) designed for physician use. There is no "standalone" algorithm performance to evaluate in this context. Therefore, this section is not applicable.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the device's performance relies on several objective measures:

• Engineering Specifications: Pre-defined specifications for RF and PMF output, frequency, power, and other physical parameters.
• International Standards: Compliance with established IEC standards for electrical safety, EMC, and software lifecycle processes (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-1-6, IEC 62304).
• Biocompatibility Standards: Compliance with ISO 10993-1.
• Predicate Device Data: The established performance, safety, and effectiveness of the legally marketed predicate devices (Venus Viva™ SR K150161 and Venus Legacy BX K142910).

8. The Sample Size for the Training Set

There is no "training set" in the context of patient data or machine learning for this device. The device itself is "trained" during its manufacturing and calibration processes to meet the specified engineering parameters and operate reliably. This is not a machine learning or AI device that undergoes training with data.

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

As there is no "training set" in the context of patient data for machine learning, this question is not applicable. The "ground truth" for the device's operational parameters is established through its design specifications, calibration procedures, and testing against known physical and safety standards during its development and manufacturing.

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