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510(k) Data Aggregation

    K Number
    K191552
    Device Name
    GM501 Mineral Oil
    Manufacturer
    Hamilton Thorne Inc.
    Date Cleared
    2019-09-18

    (98 days)

    Product Code
    MQL,MOL
    Regulation Number
    884.6180
    Type
    Abbreviated
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K053494
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    GM501 Mineral Oil is intended for use as an overlay for culture of gametes, zygotes, or embryos in Assisted Reproduction Technology (ART) and micro-manipulation procedures.

    Device Description

    GM501 Mineral Oil is light, mineral oil (paraffin oil) which is used to overlay cell culture media during Assisted Reproductive Technology (ART) or In Vitro Fertilization (IVF) procedures. The oil overlay is intended to protect the culture medium from evaporation in the incubator, limiting potential temperature, osmolality and pH changes in the medium.

    GM501 Mineral Oil is aseptically filtered and provided in bottles of 100 ml and 500 ml. This product has an 18-month shelf-life when stored as recommended.

    AI/ML Overview

    The provided text appears to be an FDA 510(k) summary for a medical device called "GM501 Mineral Oil." It does not describe an AI medical device or a study involving human readers or AI.

    Therefore, I cannot provide the information requested for acceptance criteria and a study proving a device meets these criteria, especially concerning AI, human readers, or expert evaluations. The document focuses on demonstrating substantial equivalence of a mineral oil product to a predicate device, based on similar indications for use, materials, specifications, and shelf-life, rather than providing performance data from a clinical or AI-specific study.

    The closest information provided to "acceptance criteria" are the "Specification" values in the table on page 4, which are chemical and biological characteristics of the mineral oil product rather than performance metrics for an AI algorithm.

    Table of Acceptance Criteria and Reported Device Performance (based on provided text):

    ParameterAcceptance Criteria (Specification)Reported Device Performance
    Density0.83-0.86 g/mlNot explicitly reported as a measured value for the subject device, but implied to meet specification by "Performance testing to support the subject device... supports the device specifications."
    Viscosity< 30 cP at 30°CNot explicitly reported as a measured value for the subject device, but implied to meet specification.
    Sterility (USP<71>)No growthNot explicitly reported as a measured value for the subject device, but implied to meet specification.
    Endotoxins (LAL, USP<85>)< 0.10 EU/mlNot explicitly reported as a measured value for the subject device, but implied to meet specification.
    1-Cell MEA≥ 80% blastocysts after 120h exposureNot explicitly reported as a measured value for the subject device, but implied to meet specification.
    Peroxide Value (POV)< 0.1 mEq/kgNot explicitly reported as a measured value for the subject device, but implied to meet specification.

    Regarding the other requested information, the document does not contain any of the following, as it is not a study on an AI device:

    • Sample size used for the test set and data provenance.
    • Number of experts used to establish ground truth or their qualifications.
    • Adjudication method.
    • Multi-reader multi-case (MRMC) comparative effectiveness study, nor effect size of human readers improving with/without AI assistance.
    • Standalone (algorithm only) performance.
    • Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
    • Sample size for the training set.
    • How ground truth for the training set was established.
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