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510(k) Data Aggregation

    K Number
    K992926
    Device Name
    GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195)
    Manufacturer
    RI MOS. S.R.L.
    Date Cleared
    1999-10-26

    (56 days)

    Product Code
    HHK
    Regulation Number
    884.1175
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K991895
    Why did this record match?
    Device Name :

    GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195)

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

    For endometrial sampling for histologic biopsy of the uterine mucosal lining including post menopausal patients.

    Device Description

    The RI. MOS. s.r.l. curette operates manually by applied vacuum suction and is a sterile single-use disposable device.

    AI/ML Overview

    The provided text describes a 510(k) summary for the RI. MOS. s.r.l. GINRAM® Endocic device, an endometrial suction curette. Based on the provided sections, here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implied)Reported Device Performance
    Sufficient amount of tissue collectionResults showed sufficient amount of tissue collection
    Sufficient grade of tissue collectionResults showed sufficient grade of tissue collection
    No perforationsNo perforations occurred
    No adverse eventsNo adverse events were reported
    Safe and effective collection of endometrial tissue samples by aspirationClinical sampling study conducted to evaluate Endocic's design for safe and effective collection.
    BiocompatibilitySafety tests were conducted and passed in accordance with the relevant sections of ISO 10993.

    2. Sample Size Used for the Test Set and Data Provenance

    The document mentions "A clinical sampling study was conducted" but does not specify the sample size used for this study. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective).

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

    The document does not provide information regarding the number of experts used or their qualifications for establishing ground truth. The nature of the study (tissue collection) implies pathology experts would be involved in assessing tissue grade, but this is not stated.

    4. Adjudication Method for the Test Set

    The document does not describe an adjudication method.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a clinical sampling study to evaluate the device's design.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

    This device is a manual medical instrument (curette), not an AI algorithm. Therefore, no standalone algorithm performance study was done as it's not applicable.

    7. The Type of Ground Truth Used

    The ground truth used would implicitly be histologic biopsy results to assess the "amount and grade of tissue collection."

    8. The Sample Size for the Training Set

    This device is a manual instrument; therefore, there is no "training set" in the context of an algorithm or AI. The clinical sampling study served as the evaluation or test set for the device's performance.

    9. How the Ground Truth for the Training Set Was Established

    As there is no training set for a manual device, this question is not applicable. The "ground truth" for the device's performance on the clinical sampling study would have been established by histopathological examination of the collected endometrial tissue.

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