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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.

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The Venus Viva SR system is intended for dermatological procedures requiring ablation and resurfacing of the skin.

The Venus Viva SR device is designed for non-invasive dermatological procedures requiring ablation and resurfacing of the skin. The system is designed to deliver RF energy to the skin in a fractional manner. The device is comprised of a console and an applicator. The applicator is connected to the system via a cable. The applicator (hand piece) includes a detachable electrode tip that is comprised of an array of small electrode pins. The radiofrequency energy is delivered from each of the tissue, heating the dermal layers beneath the pin with minimal injury to the epidermis layer.

This document is a 510(k) Summary for the Venus Viva SR Device, indicating that it has been determined to be substantially equivalent to a predicate device. As such, it does not contain the detailed acceptance criteria and a study dedicated to proving the device meets those criteria in the way one might expect for a novel device or a clinical trial. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device.

However, I can extract information related to performance evaluations and the animal study that supports the device's safety and effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a specific clinical outcome. Instead, it describes various tests and their "passing" or "as expected" results, demonstrating compliance with recognized standards and expected performance in a pre-clinical setting.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: The document mentions a "porcine study" (animal study). The specific number of animals or treatment sites is not specified.
• Data Provenance: The study was an animal study (porcine), which is a pre-clinical setting. The country of origin is not specified. It is implicitly a prospective study in the context of controlled experimental animal research.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• The document states "Skin biopsies were submitted for pathologic review to assess the healing profile at sites following treatment."
• Number of experts: Not specified.
• Qualifications of experts: The experts are implicitly pathologists, but their specific qualifications (e.g., years of experience) are not detailed.

4. Adjudication method for the test set

• The document mentions "gross necropsy findings" and "pathologic review." It does not specify an explicit adjudication method like "2+1" or "3+1" for interpreting these findings. It implies a standard pathological review process.

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 document describes a medical device (Venus Viva SR Device) for dermatological procedures, not an AI-assisted diagnostic tool for human readers. Therefore, this question is not applicable to the information provided.

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

• This question is not applicable. The Venus Viva SR Device is an energy-based medical device, not an algorithm. The performance evaluation focuses on the device's physical and biological effects, not on an algorithm's diagnostic accuracy.

7. The type of ground truth used

• For the animal study:
  • Direct observation: For erythema, edema, and microneedle pattern at specified time points (Day 0, Day 4, Day 14).
  • Histopathology: For assessing the healing profile of skin biopsies.
  • Gross necropsy: For evaluating overall findings.

8. The sample size for the training set

• This document describes a 510(k) submission for a medical device, not a machine learning algorithm. Therefore, there is no concept of a "training set" in this context. The device's design and parameters are based on engineering principles and comparisons to predicate devices, not on training data.

9. How the ground truth for the training set was established

• As there is no "training set" for this type of device, this question is not applicable.

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