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510(k) Data Aggregation

    K Number
    K161106
    Device Name
    PANPAC DISPOSABLE VACUUM CURETTES
    Manufacturer
    PANPAC MEDICAL CORPORATION
    Date Cleared
    2017-01-13

    (269 days)

    Product Code
    HGH
    Regulation Number
    884.5070
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PANPAC DISPOSABLE VACUUM CURETTES

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

    For transcervical aspiration of the uterine cavity.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria and the study details for a device. The document is an FDA 510(k) premarket notification letter for "Panpac Disposable Vacuum Curettes," indicating its substantial equivalence to a predicate device. It defines the device's indications for use but does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size or data provenance for a test set.
    3. Number or qualifications of experts used for ground truth.
    4. Adjudication method for a test set.
    5. Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
    6. Results from a standalone algorithm-only performance study.
    7. The type of ground truth used (e.g., pathology, outcomes data).
    8. Sample size for a training set.
    9. How ground truth for a training set was established.

    Therefore, I cannot fulfill your request based on the provided input.

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