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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:

1. A table of acceptance criteria and reported device performance related to an AI/ML algorithm.
2. Sample sizes or provenance of a test set for AI/ML.
3. Information about experts establishing ground truth for AI/ML.
4. Adjudication methods for AI/ML test sets.
5. MRMC studies for AI assistance.
6. Standalone performance of an algorithm.
7. Type of ground truth (beyond "proven safety and efficacy" for a mechanical device).
8. 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.

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