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510(k) Data Aggregation

    K Number
    K231663
    Device Name
    The AVEOtsd (Tongue Stabilizing Device) Mouthpiece
    Manufacturer
    Innovative Health Technologies (NZ), Ltd
    Date Cleared
    2023-09-18

    (103 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    The AVEOtsd (Tongue Stabilizing Device) Mouthpiece

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

    The AVEOtsd (Tongue Stabilizing Device) Mouthpiece is intended as an aid in the reduction of snoring for adults at least 18 years old.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "The AVEOtsd (Tongue Stabilizing Device) Mouthpiece." It states that the device is substantially equivalent to a predicate device for its intended use as an aid in the reduction of snoring for adults.

    However, this document does not contain any information about acceptance criteria, device performance testing, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types and establishment methods.

    The letter is a regulatory approval document confirming market clearance, not a technical report detailing the device's performance study. Therefore, I cannot answer the questions posed in the prompt based on the provided text.

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