(155 days)
The AirSculpt Body Contouring System is indicated for the removal of tissue or fluid from the body during general liposuction procedures for the purpose of aesthetic body contouring.
The AirSculpt System is a surgical device designed of subcutaneous adipose tissue during liposuction procedures performed for cosmetic purposes. The AirSculpt System includes components necessary for the vacuum-suction removal of excess adipose tissue from the body, including a handpiece that accommodates the interchangeability of lipoplasty cannulae, a console for centralized control of the system, tubing to facilitate aspiration of subcutaneous adipose tissue, and a foot pedal for operation. Other elements necessary for the use of the AirSculpt System include commonly used Class I and Class II surgical devices such as lipoplasty cannula that are introduced into the patient and swept over subcutaneous adipose tissue for suction removal and a suction canister into which aspirated adipose tissue is collected. An optional use Instrument Sleeve accessory is also available for use with the AirSculpt Handpiece and its use is based purely on physician preference.
The provided document is a 510(k) summary for the AirSculpt Body Contouring System. This type of submission is for medical devices and demonstrates substantial equivalence to a legally marketed predicate device. It does not present clinical study data for AI/ML-based software or similar technologies.
Therefore, I cannot provide the information requested regarding acceptance criteria and a study proving a device meets these criteria, specifically concerning AI/ML performance metrics, sample sizes for test sets, expert involvement in ground truthing, MRMC studies, or training set details.
The document states: "Clinical data was not required to support the substantial equivalence of the AirSculpt Body Contouring System to the predicate device." This confirms that no clinical studies as described in the prompt were conducted or submitted for this specific device.
The "Performance Data" section in the document focuses on bench testing to demonstrate conformity to specifications for a physical medical device (liposuction system), not an AI algorithm.
§ 878.5040 Suction lipoplasty system.
(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.