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510(k) Data Aggregation

    K Number
    K210294
    Device Name
    One Touch Spiral Condom
    Manufacturer
    Thai Nippon Rubber Industry Public Company Limited
    Date Cleared
    2021-09-23

    (233 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    K243421
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The One Touch Spiral Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the "One Touch Spiral Condom" and describes its indications for use. It outlines administrative details, regulatory compliance information, and contact details for further inquiries regarding FDA regulations. However, this document does not contain information about the acceptance criteria for a device's performance, nor does it detail any study proving a device meets such criteria.

    Therefore, I cannot fulfill your request for:

    • A table of acceptance criteria and reported device performance.
    • Sample size used for the test set or data provenance.
    • Number of experts or their qualifications for ground truth.
    • Adjudication method for the test set.
    • Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
    • Results of a standalone (algorithm only) performance study.
    • Type of ground truth used.
    • Sample size for the training set.
    • How ground truth for the training set was established.
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