(106 days)
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
| Acceptance Criteria (What the device was tested against) | Reported Device Performance (How the device performed) |
|---|---|
| Safety of high frequency surgical equipment (ANSI AAMI 60601-2-2) | Complies with standard |
| General Requirements for Safety of Medical Electrical Equipment (EN 60601-1) | Complies with standard |
| Electromagnetic Compatibility - Requirements and Tests (IEC 60601-1-2) | Complies with standard |
| RF Energy Test: Validate power control and accuracy | Test results show the system performs according to specifications. |
| Power Failure Safety Test: Validate power control after external power failure | Test results show the system performs according to specifications. |
| STBY Mode Power Test: Validate power control in STBY mode | Test results show the system performs according to specifications. |
| Electrode Safety Test: Validate safety by short-circuiting and open-circuiting electrodes | Test results show the system performs according to specifications. |
| Magnetic flux density Test: Measure magnetic flux density at tissue level | Test results show the system performs according to specifications. |
| Biocompatibility (ISO 10993-1) | Parts in contact with patient/user are identical to previously cleared Venus Swan parts, thus biocompatible. |
| Clinical effectiveness (non-invasive treatment of moderate to severe facial wrinkles and rhytides) | Improvement in 83% of study subjects based on photographic analysis. |
| Patient satisfaction (treatment met expectations) | Met expectations of 93% of subjects. |
| Clinical safety (unexpected adverse side effects) | No unexpected adverse side effects detected or reported. |
| Pain during treatment | All subjects reported no pain during treatments. |
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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.