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    K Number
    K961870
    Device Name
    PLAYTEX SLIMFIT TAMPONS
    Manufacturer
    PLAYTEX PRODUCTS, INC.
    Date Cleared
    1996-06-19

    (40 days)

    Product Code
    HIL
    Regulation Number
    884.5460
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PLAYTEX SLIMFIT TAMPONS

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes safety and effectiveness testing for a medical device (specifically, tampons) rather than acceptance criteria and a study to prove performance against those criteria in the context of, for example, an AI/ML-driven diagnostic device.

    Therefore, many of the requested fields are not applicable or cannot be extracted from the given input.

    Here's an attempt to interpret and fill in the information based on the provided text, highlighting where information is missing or not applicable to the context of the input:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategoryAcceptance Criteria (from text)Reported Device Performance (from text)
    TSST-1, Toxin TestingIn the range of values of commercially sold tampons.Results are in the range of values of commercially sold tampons. No significant differences between Playtex Tampons #12496 and predicate.
    Syngyna AbsorbencyRegular absorbency: 6-9 gms. Super absorbency: 9-12 gms.Regular absorbency ranges are within 6-9 gms. Super absorbency ranges are within 9-12 gms.
    Dioxin AnalysisNot detectable at limits of detection of HRGG/HRMS Method 8290.Not detectable at limits of detection of HRGG/HRMS Method 8290.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: Not specified in the provided text for any of the tests.
    • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The mention of "Triangle Labs, North Carolina" indicates where the dioxin analysis was performed, but not the origin of the samples themselves.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    • Not Applicable. The described tests (TSST-1, Syngyna, Dioxin Analysis) are laboratory-based, objective measurements, not subject to expert interpretation for ground truth establishment in the way an imaging diagnostic would be.

    4. Adjudication Method for the Test Set

    • Not Applicable. As above, these are objective lab tests, not requiring expert adjudication.

    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 type of study is relevant for AI/ML-driven diagnostic tools. The provided text describes physical/chemical properties of a tampon.

    6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

    • Not Applicable. This is also relevant for AI/ML-driven systems. The described tests are standalone measurements of product properties.

    7. The Type of Ground Truth Used

    • Objective Laboratory Measurements/Standards:
      • TSST-1, Toxin Testing: Comparison against "range of values of commercially sold tampons" and a "predicate device" serves as the reference, implying established industry standards or a benchmark.
      • Syngyna Test Results: Defined absorbency ranges (6-9 gms, 9-12 gms) are the objective ground truth for performance.
      • Dioxin Analysis: The "limits of detection of HRGG/HRMS Method 8290" is the objective ground truth against which detectability is measured.

    8. The Sample Size for the Training Set

    • Not Applicable. There is no indication of machine learning or an AI algorithm involved that would require a training set.

    9. How the Ground Truth for the Training Set Was Established

    • Not Applicable. (See #8)
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