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    K Number
    K191138
    Device Name
    AeroForm Tissue Expander, Smooth
    Manufacturer
    AirXpanders, Inc.
    Date Cleared
    2019-07-11

    (72 days)

    Product Code
    PQN,PON
    Regulation Number
    878.3510
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K182054,K161176,K170075
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AeroForm® Tissue Expander System, Smooth is used for soft tissue expansion in breast reconstruction following mastectomy, for the treatment of underdeveloped breasts and for the treatment of soft tissue deformities in the breast.

    The AeroForm® Tissue Expander, Smooth is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months

    Device Description

    The AeroForm Tissue Expander System, Smooth is a sterile, temporary implant for breast reconstruction. This device is comprised of an implantable tissue expander (Expander), a remote control (Controller), and a Master Key. The AeroForm Tissue Expander, Smooth is constructed of an outer silicone shell and an inner gas barrier (bag) with an internal reservoir of compressed Carbon Dioxide (CO2) gas. The CO2 gas is released within the Expander by using the remote control (Controller), resulting in gradual expansion of the Expander. In a typical, two-stage breast reconstruction, a tissue expander device is placed under the pectoralis major muscle and remaining skin following a mastectomy procedure. The Expander is gradually expanded over time through the release of carbon dioxide, causing the overlying skin and muscle to stretch. When adequate tissue coverage is achieved, the expansion device is removed and replaced with a breast implant.

    AI/ML Overview

    This document describes the premarket notification for the AeroForm Tissue Expander System, Smooth. The "acceptance criteria" and "device performance" in this context refer to the mechanical and performance testing conducted to demonstrate substantial equivalence to a predicate device, rather than the performance of an AI/ML model.

    Here's an analysis based on the provided text:

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria for this device are based on demonstrating that the modified device (smooth shell) meets the design input requirements and performs equivalently to the predicate device (textured shell). The study focuses on mechanical performance testing as outlined in ASTM F1441 and internal design verification and validation testing.

    Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria CategorySpecific Tests/RequirementsReported Device Performance
    Mechanical Performance- Simulated Use TestingAll mechanical performance testing results met pre-determined acceptance criteria
    - Endurance / Stress TestsAll mechanical performance testing results met pre-determined acceptance criteria
    - Dimensional MeasurementAll mechanical performance testing results met pre-determined acceptance criteria
    - Shell Tensile SetAll mechanical performance testing results met pre-determined acceptance criteria
    - Shell Break ForceAll mechanical performance testing results met pre-determined acceptance criteria
    - Non-Critical Fused or Adhered JointsAll mechanical performance testing results met pre-determined acceptance criteria
    Standard Compliance- Requirements of ASTM F1441, Standard Specification for Soft Tissue ExpandersThe device met the requirements of the ASTM F1441 standard.
    Design Control- Internal company controls and design control procedures for safety and intended useDesign verification and validation testing criteria were met.
    Risk Assessment- No new harms or risks introduced compared to predicateNo new risks were introduced as a result of the device modifications.
    Substantial Equivalence- Identical intended use, indications for use, operating principles, performance, and technological characteristics (except shell texture)Demonstrated substantial equivalence to the predicate device.

    Since this submission is for a medical device (tissue expander) and not an AI/ML product, the following points regarding AI/ML study design are not applicable to this document. The information provided does not describe an AI/ML study.

    1. Sample size used for the test set and the data provenance: Not applicable; no AI/ML test set is described.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; ground truth establishment for an AI/ML model is not described.
    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable; no expert adjudication for an AI/ML test set.
    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable; no AI assistance for human readers is described.
    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable; this device is not an algorithm.
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable; no ground truth for an AI/ML model. The "ground truth" for this device's performance is derived from standardized mechanical testing and design verification.
    7. The sample size for the training set: Not applicable; no AI/ML training set is described.
    8. How the ground truth for the training set was established: Not applicable; no AI/ML training set is described.
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