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510(k) Data Aggregation

    K Number
    K955336
    Device Name
    SNOREFREE
    Manufacturer
    SCOTT FELDMAN DDS & NORMAN SHAPIRO DDS
    Date Cleared
    1996-01-04

    (45 days)

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

    SNOREFREE

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

    Not Found

    Device Description

    Snorefree

    AI/ML Overview

    This document is a letter from the FDA to Dr. Scott E. Feldman regarding the 510(k) premarket notification for a device named "Snorefree." The letter states that the FDA has determined the device is substantially equivalent to devices marketed prior to May 28, 1976, and therefore, it can be marketed subject to general controls provisions of the Act.

    The document does not contain information about:

    1. Acceptance criteria and reported device performance.
    2. Sample sizes, data provenance, or details about the test set.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method.
    5. Multi reader multi case (MRMC) comparative effectiveness study.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    This letter is a regulatory approval document based on substantial equivalence, not a study report detailing performance metrics and validation methods. Therefore, I cannot extract the requested information from the provided text.

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