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510(k) Data Aggregation

    K Number
    K152336
    Device Name
    HEX tanning booth
    Manufacturer
    J & B PRODUCTS LTD DBA HEX TANNING
    Date Cleared
    2016-05-02

    (257 days)

    Product Code
    LEJ
    Regulation Number
    878.4635
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Sunlamp product for tanning of human skin

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a tanning booth device. It discusses regulatory matters, product codes, and indications for use.

    This document does not contain any information about acceptance criteria for a medical device's performance, nor does it describe any study that proves a device meets such criteria. It is solely a regulatory approval letter for a Hex Tanning Booth.

    Therefore, I cannot extract the requested information regarding:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes and data provenance for a test set.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method for the test set.
    5. MRMC comparative effectiveness study details.
    6. Standalone performance details.
    7. Type of ground truth used.
    8. Training set sample size.
    9. How ground truth for the training set was established.

    To answer your request, I would need a document that describes the performance evaluation of a medical device, including its acceptance criteria and the results of a study conducted to demonstrate its performance.

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