(95 days)
The Venus Bliss 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 Bliss device is intended for the treatment of the following medical conditions; using the MPapplicator 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
The Venus Bliss device consists of a console (main unit), one RF applicator and four Diode Laser applicators. The system delivers laser (Diode Laser Applicators) and bipolar RF energies, vacuum pressure, and pulsed magnetic fields (PMF) to the skin (MP2 applicator) and the underlying tissues of the treatment area.
The console of the Venus Bliss device contains a power supply unit, Laser and RF 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 provided text (K190743 FDA 510(k) clearance document for the Venus Bliss device) does not contain information about the acceptance criteria or a study that proves the device meets specific performance acceptance criteria for an AI/ML powered device.
The document primarily focuses on demonstrating substantial equivalence to predicate devices (Venus Legacy CX and Cynosure's SculpSure) based on intended use, technological characteristics, and principles of operation for regulatory clearance. It describes general performance testing conducted, such as:
- Performance Bench Testing: To evaluate device outputs per specifications and compare to predicate device specifications.
- Electrical Safety and Electromagnetic Compatibility: Testing against applicable IEC standards.
- Software Testing: Verification and validation testing.
However, these tests are for the physical device's fundamental operation and safety standards, not for the performance of an AI/ML algorithm that predicts or diagnoses based on analyzed data.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device's performance, because this document describes a physical medical device (diode laser system and RF applicator), not an AI/ML driven one.
If you have a document describing an AI/ML device that has undergone clinical validation and performance testing, please provide that document, and I would be happy to extract the information.
§ 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.