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510(k) Data Aggregation

    K Number
    K212024
    Device Name
    PAL System
    Manufacturer
    MicroAire Surgical Instruments, LLC
    Date Cleared
    2022-06-10

    (346 days)

    Product Code
    QPB,MUU
    Regulation Number
    878.5040
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K973268,K053451
    Why did this record match?
    Device Name :

    PAL System

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For aesthetic body contouring

    Device Description

    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.

    AI/ML Overview

    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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