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510(k) Data Aggregation

    K Number
    K080752
    Device Name
    CONCEIVEX LATEX-FREE SEMEN COLLECTOR
    Manufacturer
    CONCEIVEX INC.
    Date Cleared
    2008-05-14

    (58 days)

    Product Code
    OBB
    Regulation Number
    884.5250
    Type
    Special
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K050828,K063227
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sagami Polyurethane Semen Collection Device is intended to be used as an accessory to the Oves Cervical Cap to collect semen for transfer to the cap prior to insertion in artificial insemination procedures.

    Device Description

    The subject device is a polyurethane condom.

    AI/ML Overview

    Here's the analysis of the provided text regarding the acceptance criteria and study for the Conceivex Latex-free Semen Collector:

    Acceptance Criteria and Reported Device Performance

    The provided text does not explicitly state quantitative acceptance criteria in a table format, nor does it provide numerical performance results. Instead, it relies on a qualitative assessment of "no deleterious effects" compared to predicate devices.

    Acceptance Criteria (Inferred)Reported Device Performance
    No deleterious effects on human semen."Human Sperm Survival Assay... demonstrated that the condom material has no deleterious effects on human semen."
    No deleterious effects on embryo development."Mouse Embryo Assay performed on the Sagami non-latex condom demonstrated that the condom material has no deleterious effects on... embryo development."
    Equivalence in safety and effectiveness to predicate devices."The results of this testing demonstrate that the new devices is as safe and effective as the predicates."

    Study Details

    1. Sample size used for the test set and the data provenance:

      • Human Sperm Survival Assay: Not specified.
      • Mouse Embryo Assay: Not specified.
      • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here refers to the biological assays (sperm survival, embryo development) which are scientific measurements rather than expert interpretations.

    3. Adjudication method for the test set: Not applicable. This concept typically applies to studies where human reviewers assess data against a standard, not to laboratory assays.

    4. 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 study focuses on the biological safety of a device material, not on AI-assisted diagnostic effectiveness.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical semen collector, not an algorithm.

    6. The type of ground truth used:

      • Human Sperm Survival Assay: Biological assay measuring sperm viability/function.
      • Mouse Embryo Assay: Biological assay measuring embryo development.

    7. The sample size for the training set: Not applicable. This is not a machine learning or AI-driven device, so there is no training set in the conventional sense.

    8. How the ground truth for the training set was established: Not applicable, as there is no training set. The "ground truth" for the testing (assays) was established through scientific measurement in laboratory conditions.

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