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510(k) Data Aggregation

    K Number
    K023403
    Device Name
    SPERMGRAD, MODELS 10022/10063
    Manufacturer
    VITROLIFE SWEDEN AB
    Date Cleared
    2002-12-13

    (64 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K991341
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Intended Use: Medium for In Vitro Fertilization Procedures
    • Indications for Use: For gradient sperm separation.
    Device Description

    Physiological salt buffer containing silane-coated, colloid silica particles. For use after appropriate dilution.

    AI/ML Overview

    This submission is not for an AI/ML powered device, but rather for a medical device called SpermGrad™, which is an assisted reproduction medium. Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable.

    However, I can extract and present the information relevant to this medical device submission.

    1. Table of Acceptance Criteria and Reported Device Performance

    For this type of medical device (assisted reproduction media), acceptance criteria typically relate to demonstrating substantial equivalence to a predicate device, primarily through technological characteristics and intended use. Performance is often measured indirectly by showing comparable or equivalent functionality.

    Acceptance Criteria (Inferred from 510(k) Process)Reported Device Performance
    Intended Use Equivalence: Device has the same intended use as legally marketed predicate device."Médium for In Vitro Fertilization Procedures" and "For gradient sperm separation." - Identical to predicate.
    Technological Characteristics Equivalence: Device has identical technological characteristics to the predicate device in all material respects."The technological characteristics of SpermGrad™ are identical to the predicate device in all material respects."
    Safety and Effectiveness: Demonstration that the device is as safe and effective as the predicate device.Achieved via substantial equivalence determination based on identical technological characteristics and intended use. No specific performance metrics for this type of device are presented in the provided text, as safety and effectiveness are inferred by the substantial equivalence to a legally marketed predicate with a known safety and effectiveness profile.

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Not Applicable. This is a 510(k) submission for an assisted reproduction media (SpermGrad™) where substantial equivalence is claimed based on identical intended use and technological characteristics to a predicate device (ISolate® - K991341). The information provided does not indicate a clinical study with a "test set" in the context of device performance data generation. Clinical data is typically not required for device classifications like this where substantial equivalence can be demonstrated through other means.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    • Not Applicable. See point 2.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Not Applicable. See point 2.

    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 device is an assisted reproduction media, not an AI/ML-powered diagnostic or assistive tool for human readers.

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

    • Not Applicable. This is not an algorithm or AI device.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

    • Not Applicable. No explicit "ground truth" as would be defined for an AI/ML device needing validation against a gold standard is mentioned or implied for this submission. Substantial equivalence relies on comparison to a predicate device.

    8. The sample size for the training set

    • Not Applicable. This is not an AI/ML device requiring a training set.

    9. How the ground truth for the training set was established

    • Not Applicable. See point 8.
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