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510(k) Data Aggregation

    K Number
    K992282
    Manufacturer
    Date Cleared
    1999-09-23

    (78 days)

    Product Code
    Regulation Number
    878.5040
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Liposuction cannulas are indicated for aesthetic body contouring and general tissue aspiration.

    Device Description

    Micro-France liposuction cannulas consist of a hollow stainless steel tube with one or more distal openings and a handle with a suction line connector.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device (Micro-France Liposuction Cannulas). It does not contain the acceptance criteria or a study proving the device meets those criteria in the way typically seen for AI/ML-based diagnostic devices.

    The document is primarily concerned with establishing "substantial equivalence" to a predicate device, a regulatory pathway that focuses on comparing a new device to a legally marketed one, rather than demonstrating de novo performance against specific clinical endpoints with detailed statistical studies.

    Therefore, most of the requested information cannot be extracted from this document.

    Here's an assessment based on the available information:

    • No information on acceptance criteria or performance study results is provided. The 510(k) process for this device relies on demonstrating similarity to a predicate, not on a new performance study with acceptance criteria.

    However, I can extract information related to the device itself and the regulatory context:

    Device Information:

    • Device Name: Micro-France Liposuction Cannulas
    • Intended Use: Aesthetic body contouring and general tissue aspiration.
    • Device Description: Consist of a hollow stainless steel tube with one or more distal openings and a handle with a suction line connector.
    • Predicate Devices: Byron Medical (K981172) and Wells Johnson Co. (K832520)

    Regarding your specific questions:

    1. A table of acceptance criteria and the reported device performance: Not applicable. This document does not describe acceptance criteria for a performance study nor does it report device performance against such criteria. The "performance" demonstrated here is primarily through substantial equivalence to predicate devices, implying similar safety and effectiveness.
    2. Sample sized used for the test set and the data provenance: Not applicable. No test set or clinical study data is mentioned for this 510(k) submission.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is discussed.
    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set adjudication is discussed.
    5. 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. This is not an AI/ML device, and no MRMC study is mentioned.
    6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.
    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth for device performance is discussed beyond the regulatory assertion of substantial equivalence.
    8. The sample size for the training set: Not applicable. This is not an AI/ML device, and no training set is mentioned.
    9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device, and no training set is mentioned.
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