(100 days)
The Venus BlissMAX device is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less.
In addition, the Venus BlissMAX device is intended for the treatment of the following medical conditions; using the MP2 applicator for delivery of RF energy 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
In addition, The Venus BlissMAX device using the FlexMAX applicators is intended for muscle conditioning to stimulate healthy muscles.
The Venus BlissMAX device using the FlexMAX applicators is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.
The Venus BlissMAX device using the FlexMAX applicators is intended to be operated by a trained professional.
The Venus BlissMAX device is a computerized system comprised of a system console (main unit), four (4) Diode Laser applicators, one (1) MP2 (RF+ PEMF+ Vacuum) applicator and four (4) FlexMAX (EMS) applicators. The system delivers laser, bipolar RF and biphasic electrical energies, vacuum pressure, and pulsed electromagnetic fields (PEMF) to the skin and the underlying tissues of the treatment area. The device provides individual adjustment of laser power, EMS intensity level, and RF power, in addition to vacuum levels, for each patient.
The console of the Venus BlissMAX device contains a power supply unit, Laser, RF, and EMS controllers, (power modules, on main board), a suction module (vacuum), a controller unit (on main board), Laser water cooling system (power module, on main board), a touch- screen user interface and display panel.
The applicators are connected to the console via a cable. The RF applicator is comprised of various combinations of RF electrodes, magnetic coils, and vacuum conduits. The Laser applicators are comprised of a light guide, touch sensors and light-emitting diodes.
The EMS applicator is comprised of two electrodes and a light indicator.
The provided text is a 510(k) summary for the Venus BlissMAX device, which is an electrosurgical cutting and coagulation device. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and comprehensive study results for efficacy.
However, based on the "Performance Data" subsection, we can infer some aspects of the acceptance criteria and the studies performed to demonstrate compliance.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the device's therapeutic claims (e.g., non-invasive lipolysis, muscle aches/pain, cellulite reduction, muscle conditioning) in a way that suggests a clinical trial with specific endpoints. Instead, it focuses on demonstrating that the device meets safety and performance standards.
The "Performance Bench Testing" implies that the device's outputs were measured against predefined specifications. These specifications would be the acceptance criteria for those particular performance tests.
| Acceptance Criteria (Inferred from Performance Data) | Reported Device Performance (Summary) |
|---|---|
| Compliance with performance standards | "Venus Concept conducted several performance tests to demonstrate that the Venus BlissMAX device complies with performance standards and that it functions as intended." The results demonstrated that differences in technological characteristics do not raise new types of safety or effectiveness concerns. |
| Device output per specifications | "Several performance tests were performed, including software validation and device verification tests in order to evaluate the Venus BlissMAX device's outputs per specifications. The results demonstrated that the differences in the technological characteristics of the subject and predicate devices do not raise new types of safety or effectiveness concerns." |
| Compliance with applicable electrical safety and electromagnetic compatibility standards (listed IEC standards) | "The device was tested per the applicable electrical safety and electromagnetic compatibility standards listed below, and all results were passing." |
| Software correctly functions as intended | "The software was also subjected to verification and validation testing, and results demonstrated that the system performed as intended." |
| No new types of safety or effectiveness concerns | "These performance tests demonstrated that the device meets the system requirements and do not raise new types of safety or effectiveness concerns." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not mention a "test set" in the context of clinical data for efficacy. The performance tests mentioned (bench testing, electrical safety, software validation) are primarily engineering and quality assurance tests. There is no information regarding sample size, country of origin, or whether it was retrospective or prospective for a clinical test set.
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 does not describe a clinical test set requiring expert ground truth establishment for diagnostic or therapeutic outcomes. The performance data discussed pertains to device functionality and safety standards, which are typically evaluated by engineers and regulatory compliance experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As no clinical test set requiring expert adjudication for ground truth is described, there is no mention of an adjudication method.
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. The Venus BlissMAX device is not an AI-assisted diagnostic or therapeutic imaging device, and therefore, an MRMC study is not relevant to its assessment.
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, not an algorithm. Its operation inherently involves a "trained professional," as stated in the Indications for Use for the FlexMAX applicators.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance and safety tests described:
- Performance Bench Testing: The "ground truth" would be the predefined engineering specifications and functional design of the device.
- Electrical Safety and Electromagnetic Compatibility: The "ground truth" is compliance with international standards (e.g., IEC 60601 series).
- Software Testing: The "ground truth" is adherence to software requirements and functionality as per design specifications.
For the claims of efficacy, the document states "The results demonstrated that the differences in the technological characteristics of the subject and predicate devices do not raise new types of safety or effectiveness concerns." This suggests the efficacy is primarily being demonstrated through substantial equivalence to previously cleared predicate devices, rather than new clinical outcomes data.
8. The sample size for the training set
Not applicable. As this device is not an AI/machine learning product requiring a training set in the conventional sense, this information is not provided.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/machine learning model.
§ 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.