Search Results

The Venus Legacy CX device is intended for the treatment of the following medical conditions; using the LB2 and LF2 applicators for delivery of non-thermal RF combined with massage and magnetic field pulses:

• Relief of minor muscle aches and pain, relief of muscle spasm .
• Temporary improvement of local blood circulation .
• Temporary reduction in the appearance of cellulite

The Venus Legacy CX device consists of a console (main unit) and two applicators (LB2, LF2). The console in the Venus Legacy CX device contains a power supply unit, an RF generator (power module, on main board), a suction module (vacuum), a controller unit (on main board) and a touchscreen user interface and display panel. The Venus Legacy CX device provides RF treatments combined with emitted magnetic fields and vacuum massaging. The Vacuum is mainly used for the massaging of deep tissues by creating mild to deep suction. The vacuum massage contributes to the sub-dermal and adipose tissues shrinkage and improves the contact surface between electrodes and tissue. The RF currents heat the adipose and muscular tissues to trigger tissue level changes leading to temporary reduction in the appearance of cellulite and temporary relief of muscle pain and muscle spasm. The RF heating effect also improves local blood circulation in the sub dermal layers. The PMF assists in achieving treatment effect.

This document, a 510(k) summary for the Venus Legacy CX device, primarily focuses on demonstrating substantial equivalence to a predicate device (Viora Reaction System) rather than proving the device meets specific performance acceptance criteria through clinical studies with human participants. Therefore, many of the requested categories related to clinical study design, sample sizes, expert adjudication, and comparative effectiveness studies are not applicable or cannot be extracted from this document directly.

The document emphasizes performance bench testing to show similarity to the predicate device.

Here's the information that can be extracted, and an explanation for the areas where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) summary demonstrating substantial equivalence, explicit "acceptance criteria" for clinical performance (e.g., specific percentages of cellulite reduction in a defined population) are not provided. Instead, the "performance" discussed is related to engineering and bench testing comparisons to the predicate.

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

• Test Set (Clinical): Not applicable. This document does not describe a clinical test set with human participants.
• Test Set (Bench/Pre-clinical):
  • Porcine Tissue for Thermal Profile: The document mentions "porcine tissue" but does not specify the sample size (e.g., number of tissue samples or animals).
  • Other Bench Tests: No specific sample sizes for components or systems tested are provided, other than "several performance tests" and "validation study."
• Data Provenance: Not specified, but generally, bench testing data would be generated in a lab setting, likely in the country of manufacture (e.g., USA or where Venus Concept operates). The testing is prospective for the purpose of this 510(k).

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

• Not applicable. No clinical ground truth established by experts is mentioned as this is a 510(k) based on substantial equivalence using bench testing.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set with expert adjudication is described in this document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. This document does not mention an MRMC comparative effectiveness study, as it relies on substantial equivalence through bench testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical medical device (electrosurgical unit) and not an AI algorithm. Its performance is inherent to the device's physical operation, not an algorithm's standalone output.

7. The Type of Ground Truth Used

• For Bench Testing: The "ground truth" for the bench testing would be established by objective measurements and comparisons against the specifications of the predicate device and relevant international standards (e.g., RF output, thermal profiles, electrical safety standards).
• For Biocompatibility: Ground truth involved established ISO standards for cytotoxicity, intracutaneous testing, and sensitization, along with previous clearance of an equivalent device.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI algorithm that requires a training set.

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

• Not applicable. This device is not an AI algorithm that requires a training set.

Ask a specific question about this device