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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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The Venus Swan (MP)2 system is a non-invasive device 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.

The Venus Swan (MP)2 TM System uses Radiofrequency (RF) energy in (MP)2 technology for treatment. (MP)2 technology is a Multi-Polar array of Bi-Polar RF electrodes together with Pulsed Magnetic Field (PMF). The Venus Swan(MP)2 TM is a modification to the previously cleared Venus Concept's Venus Swan system (K100586). The Venus Swan (MP)2 is a noninvasive, non-ablative device consisting of Main Unit (console) - Touch Screen user interface, RF Power module, Controller unit, and Two optional treatment applicators: Octipolar-MTM applicator for medium sized treatment areas, composed of 8 (1) RF electrodes, 8 electrode coils assembled over the electrodes and a central coil (the RF is emitted through the electrodes. The PMF is generated by the coils), and (2) Diamondpolar™ applicator for small treatment areas, composed of 4 RF electrodes, 4 electrode coils (the RF is emitted through the electrodes. The PMF is generated by the coils).

Here's the breakdown of the acceptance criteria and the study that supports the Venus Swan (MP)2 System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Clinical Study): 31 subjects
• Data Provenance: Not explicitly stated, but clinical studies for FDA clearance are typically prospective. The country of origin for the data is not specified in the document, but the applicant is based in Israel, so it could potentially be an international study or a study conducted in Israel.

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

• Number of Experts: "Uninvolved reviewers" performed the photographic analysis. The exact number of reviewers is not specified.
• Qualifications: Not specified. It only states they were "uninvolved reviewers."

4. Adjudication Method for the Test Set

• The document mentions "Photographic analysis of pre-and post treatment of the digital images was conducted by uninvolved reviewers." This indicates that reviewers were used to assess improvement, but it does not specify an adjudication method like 2+1 or 3+1 for conflicting assessments.

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

• No, an MRMC comparative effectiveness study was not done. The document describes a clinical study focused on the safety and effectiveness of the device itself, not comparing human readers with and without AI assistance. The device in question is not an AI-assisted diagnostic tool but a therapeutic medical device.

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

• This question is not applicable as the Venus Swan (MP)2 is a physical medical device (RF and PMF system), not an algorithm or AI system. Its performance is measured directly through its physical output and clinical outcomes, not as a standalone algorithm.

7. The Type of Ground Truth Used

• Clinical Efficacy: Photographic analysis by uninvolved reviewers (likely a visual assessment of wrinkle and rhytide improvement).
• Patient Experience: Subject reporting (for pain and expectation fulfillment).
• Safety: Direct observation for adverse events.

8. The Sample Size for the Training Set

• Not applicable. As this is a physical medical device, there isn't a "training set" in the context of machine learning or AI. Performance is based on engineering specifications and clinical trials.

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

• Not applicable. See point 8.

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Noninvasive treatment of mild to moderate facial wrinkles and rhytides. This device has not been tested on darker skin subjects.

MINNIE is a noninvasive radiofrequency device consisting of:
• Touch Screen User interface
• Programmable Microcontroller
• RF Power Module
• 4 Treatment Handpieces with following characteristics
o Bipolar Handpiece Ø 36mm
o Unipolar Handpieces Ø 36mm, 60mm and 80mm
MINNIE is a portable system used to deliver radiofrequency energy to the patient treatment site via a delivery handpiece.

MINNIE Device Performance Study

This response outlines the acceptance criteria and study details for the MINNIE device, based on the provided 510(k) summary (K133405).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set (Clinical Study): 52 subjects
  • Group A (Control): 8 subjects
  • Group B (Sham): 11 subjects
  • Group C (Radiofrequency Treatment): 33 subjects
• Data Provenance: Not explicitly stated, but the applicant (Elettronica Valseriana srl) is based in Italy, suggesting the study may have been conducted there. The study appears to be prospective as subjects were randomly assigned to groups and followed up.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

• Number of Experts: 3 physicians
• Qualifications: "Blind to the randomization group," implying independence and impartiality. Specific years of experience or subspecialty (e.g., dermatologist, plastic surgeon) are not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Implicitly, consensus or strong agreement. The summary states, "There were no differences in the scoring of the evaluators," suggesting that the 3 physicians' evaluations (on clinical photographs) matched the in-vivo scores made by the investigator. If there were discrepancies, an adjudication method was not explicitly described, but their agreement eliminates the need for one.

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

• **No, a specific MRMC comparative effectiveness study comparing human readers with and without AI assistance was not done.
• The study involved human readers (3 blinded physicians and the investigator) assessing wrinkles using a standardized scale. The device itself is an energy delivery system, not an AI-based diagnostic or assistive reader tool. Therefore, an MRMC study in the typical AI context is not applicable here.

6. Standalone Performance Study (Algorithm Only)

• **No, a standalone (algorithm only) performance study was not done.
• The MINNIE device is a medical device that delivers radiofrequency energy, not an algorithm that interprets data or provides diagnostic output. The clinical study assessed the effect of the device on human subjects.

7. Type of Ground Truth Used

• Ground Truth Type: Expert consensus (for evaluations from photographs by blinded physicians that confirmed the in-vivo scores by the investigator) and clinical assessment using a standardized scale (Fitzpatrick Wrinkle Scale - FWS).

8. Sample Size for the Training Set

• Training Set Sample Size: A separate training set for an algorithm is not applicable as the MINNIE device is a hardware-based radiofrequency treatment system, not an AI software. The provided document describes a clinical study to evaluate the device's safety and effectiveness in treating wrinkles, not to train a machine learning model.

9. How Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not applicable as there is no training set for an algorithm. The clinical study used the FWS as a measure to assess the device's effects on human subjects.

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The Venus Swan™ is a non-invasive device intended for use in Dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.

The Venus Swan™ System uses Radiofrequency (RF) energy in (MP)2 technology for treatment. (MP)2 technology is a Multi-Polar array of Bi-Polar RF electrodes. The Venus Swan™ is a modification to the previously cleared Venus Concept's Venus Freeze system (K100586). The Venus Swan™ is a non-invasive system consisting of: - Main Unit (console) - Touch Screen user interface - RF Power module Controller unit Three optional treatment applicators: (1) Octipolar-LTM applicator - for large treatment areas, composed of 8 RF electrodes (2) Octipolar-M™ applicator - for medium sized treatment areas, composed of 8 RF electrodes (3) Diamondpolar™ applicator - for small treatment areas, composed of 4 RF electrodes The system can be connected to two applicators only at a time. The user can choose which applicator to use according to the size of the treatment area. The Touch screen user interface provides: - Applicator selection - RF Power Output and Treatment Time parameter adjustments - Current treatment parameters display. The RF power module provides RF energy to the selected applicator, producing a 1MHz signal.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested. The document is a 510(k) summary for the Venus Swan System, which focuses on device description, intended use, and substantial equivalence to a predicate device (Venus Freeze) rather than detailed clinical study results with specific performance metrics and acceptance thresholds.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert qualifications, ground truth, or comparative effectiveness studies.

The document primarily states:

• Intended Use: Non-invasive treatment of mild to moderate facial wrinkles and rhytides.
• Performance Standards: Compliance with general electrical and medical device safety standards (EN 60601-1, IEC 60601-1-2, ANSI AAMI 60601-2-2).
• Substantial Equivalence: Claims substantial equivalence to the Venus Freeze (K100586). This typically means that the manufacturer asserts the new device is as safe and effective as a legally marketed predicate device, and often relies on similar technological characteristics and performance rather than new, extensive clinical studies for standalone performance claims against specific clinical acceptance criteria.

To answer your request, a different type of document, such as a full clinical study report, would be needed.

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