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510(k) Data Aggregation

    K Number
    K992269
    Device Name
    VENTIL-A ORAL PROTECTOR
    Manufacturer
    SOMATICS, INC.
    Date Cleared
    1999-10-25

    (111 days)

    Product Code
    JXL
    Regulation Number
    882.5070
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VENTIL-A ORAL PROTECTOR

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

    The Somatics Ventil-A™ oral protector is a single-use (disposable) oral protector for use during seizures induced by electroconvulsive therapy, spontaneous seizures, or for protection of the teeth, lips, tongue, and buccal mucosa (e.g., during cardioversion).

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "Ventil-A," an oral protector. The letter indicates that the device has been found substantially equivalent to a predicate device. However, this document does not contain specific information about acceptance criteria or a study that proves the device meets those criteria.

    Therefore, I cannot provide the requested information, which includes:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method for a test set.
    5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
    6. Results of a standalone (algorithm only) performance study.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    This document is a regulatory approval notice, not a performance study report.

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