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

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

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

The Venus Viva MD™ 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 MD and Diamondpolar applicators can now be connected simultaneously to a single console, the Venus Viva MD™ console.

Additionally, the Viva MD applicator is supplied with single use detachable tips with 80- or 160-electrode pins. The 160-pin tip was previously cleared within Venus Viva SR (K150161).

This document is a 510(k) Summary for the Venus Viva MD™ device, indicating it is a submission to the FDA to demonstrate substantial equivalence to previously cleared predicate devices. The information provided heavily focuses on comparing technological characteristics and safety standards rather than detailed acceptance criteria and a specific study proving those criteria are met in the traditional sense of a clinical trial for diagnostic performance.

However, I can extract the relevant information regarding performance testing and how substantial equivalence was established, which acts as the "proof" for regulatory clearance.

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

Based on the document, the "acceptance criteria" are not explicitly stated with numerical targets in a table format as one might find for a diagnostic algorithm's sensitivity/specificity. Instead, the acceptance criteria are implicitly that the Venus Viva MD™ device must perform similarly to its predicate devices and meet relevant safety and electrical standards. The reported device performance is that these similarities were confirmed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Bench Testing: No specific "sample size" is mentioned for RF and PMF output parameter testing. This typically involves instrument calibration and performance checks, not patient data.
• Animal Testing: The study involved "porcine skin." The number of animals or specific treatment sites is not specified. The provenance would be the location where the animal study was conducted, which is not stated (likely a research lab). It's a prospective study in an animal model.
• Electrical Safety, EMC, Usability, Software Testing: These are engineering and software validation tests, not clinical studies with patient data. No "sample size" in the context of patients is relevant.

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)

• Animal Testing (Histology): For the animal study, the ground truth was established histologically. This implies a pathologist reviewed the tissue samples. The number of experts and their qualifications are not specified in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Animal Testing: No information is provided regarding an adjudication method. Histological review is generally performed by a single pathologist or might be peer-reviewed, but methods are not detailed here.

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

• This device is an electrosurgical cutting and coagulation device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not applicable and was not conducted.

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

• This is a physical medical device (console and applicators), not a standalone algorithm. Performance is based on its physical and electrical outputs and biological effects, as demonstrated in bench and animal testing.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Animal Testing: Pathology (histological evaluation of ablated skin and healing).
• Bench/Engineering/Software Testing: Ground truth is defined by engineering specifications, validated test protocols, and international standards (e.g., IEC 60601 series).

8. The sample size for the training set

• Not applicable. This is a medical device clearance submission, not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for the device's design would come from engineering principles and prior predicate device designs.

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

• Not applicable as it's not an AI/ML algorithm requiring a training set.

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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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When used with the Octipolar (LB1) or Diamondpolar (LF1) applicators, the Venus Legacy Pro device is intended for use in dermatologic and general surgical procedures for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV.

When used with the 4D Body (LB2) or 4D Face (LF2) applicators, the Venus Legacy Pro device is intended for the delivery of non-thermal RF combined with Massage and magnetic field pulses for the treatment of the following medical conditions:

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

The Venus Legacy Pro device consists of a console (main unit) and four applicators - Octipolar (LB1), Diamondpolar (LF1), 4D Body (LB2) and 4D Face (LF2). The console 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 Pro device combines two previously cleared devices (Legacy BX, K142910 and Legacy CX. K143554) into one device. The two applicators that were cleared for the Legacy BX Device - Octipolar (LB1) and Diamondpolar (LF1) and the two applicators that were cleared for the Legacy CX device - 4D Body (LB2) and 4D Face (LF2) can now be connected simultaneously to a single console, the Legacy Pro device's console.

The provided text describes the Venus Legacy Pro device, its intended uses, and its substantial equivalence to previously cleared predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in terms of clinical performance metrics like sensitivity, specificity, accuracy, or effect size of human improvement with AI assistance.

Instead, the performance data presented focuses on engineering and regulatory compliance, not clinical outcomes.

Here's an analysis based on the information available in the text:

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

The document does not explicitly present a table of acceptance criteria for clinical performance (e.g., reduction in wrinkles by a certain percentage, pain relief score, cellulite reduction percentage). The "Performance Data" section primarily addresses engineering and regulatory compliance.

However, based on the bench tests mentioned, we can infer some performance targets for temperature control:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No information is provided regarding sample sizes for clinical test sets as the document focuses on technical performance and regulatory equivalence rather than clinical efficacy studies for this 510(k) submission. The "bench tests" mentioned are likely laboratory tests, not clinical studies with patients.

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):

Not applicable. The document discusses device safety, performance verification, and substantial equivalence to predicates, not the establishment of ground truth for a clinical test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This information is relevant for clinical studies involving human assessment, which are not detailed in this document.

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:

Not applicable. This device is not an AI-assisted diagnostic or interpretation tool for human readers. It is a physical medical device for treatment.

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

Not applicable. This device is not an algorithm for standalone performance assessment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the bench tests, the "ground truth" would be the device's design specifications for temperature output, electrical safety, and electromagnetic compatibility. For clinical efficacy (e.g., wrinkle reduction, pain relief), the document does not describe studies that would establish such ground truth for the Venus Legacy Pro device. It relies on the indications for use of its predicate devices.

8. The sample size for the training set:

Not applicable. The document does not describe a machine learning algorithm that requires a training set.

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

Not applicable.

Summary of what the document focuses on:

The entire document pertains to a 510(k) premarket notification for the Venus Legacy Pro Device. This type of submission primarily demonstrates substantial equivalence to a previously cleared predicate device, rather than performing de novo clinical efficacy trials to establish new acceptance criteria.

The "Performance Data" section discusses:

• Bench Testing: To ensure the device's outputs meet specifications (e.g., temperature ranges for applicators) and are comparable to predicate devices.
• Electrical Safety and Electromagnetic Compatibility: Compliance with international standards (IEC 60601 series).
• Software Testing: Verification and validation to confirm the software performs as intended.

The acceptance criteria are therefore implicitly tied to meeting these engineering and regulatory standards, and demonstrating that any differences from the predicate devices do not raise new safety or effectiveness concerns. The study described is a series of engineering and regulatory compliance tests, not a clinical trial with human subjects to prove clinical efficacy against specific, measurable outcomes that would typically be described with metrics like sensitivity, specificity, or reader improvement.

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