(346 days)
For aesthetic body contouring
The MicroAire® Power Assisted Liposuction (PAL) System is a medical device intended to be used for the aspiration of autologous adipose tissue in lipoplasty procedures. The PAL system consists of three components: electric instrument console, handpiece, and cable. The PAL-650 handpiece is powered by the MicroAire 5020 Electric Instrument Control console via the 5006 PAL cable and connected to an independent aspiration source. The PAL-650 handpiece reciprocates a cannula used in liposuction procedures for aspiration of fat tissue.
I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets the acceptance criteria in the context of AI/ML performance.
The document is a 510(k) premarket notification for a medical device called the "PAL System" (Power Assisted Liposuction System) manufactured by MicroAire Surgical Instruments, LLC. It details the device's substantial equivalence to a predicate device, the Vibrasat® Power, for the indication of aesthetic body contouring.
The information provided focuses on:
- Regulatory information: FDA clearance, product codes, regulation numbers.
- Device description: Components (console, handpiece, cable), mechanism of action, physical characteristics.
- Comparison to a predicate device: Highlighting similarities and differences in intended use, technology, user, physical characteristics, performance (e.g., strokes/min), electrical safety, and reuse (cleaning/sterilization).
- Non-clinical performance data: Listing various bench tests performed (biocompatibility, electrical safety, EMD, software verification/validation, mechanical tensile testing, sterilization validation, transportation testing).
- Clinical performance data: Stating that no human clinical testing was required because the indications for use are equivalent to the predicate device and the device type has a long history of safe and effective use.
Therefore, the document does not include:
- A table of acceptance criteria and reported device performance related to an AI/ML algorithm.
- Sample sizes or provenance of a test set for AI/ML.
- Information about experts establishing ground truth for AI/ML.
- Adjudication methods for AI/ML test sets.
- MRMC studies for AI assistance.
- Standalone performance of an algorithm.
- Type of ground truth (beyond "proven safety and efficacy" for a mechanical device).
- Sample size for a training set or how its ground truth was established, as this is not an AI/ML device submission.
The document describes the regulatory pathway for a conventional medical device, not an AI/ML model.
§ 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.