LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K130046
    Device Name
    CLEARSPEC SINGLE USE VAGINAL SPECULUM
    Manufacturer
    CLEARSPEC LLC
    Date Cleared
    2013-08-06

    (210 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K050887,K120743
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLEARSPEC LLC

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

    The ClearSpec Single-Use Vaginal Speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures.

    Device Description

    The ClearSpec Single Use Vaginal Speculum is a disposable vaginal speculum constructed of polystyrene, used to dilate the vagina and expose the interior of the vagina and exterior of the cervix, and employs a unique flexible polyurethane sheath that is designed to assist in keeping the lateral walls of the vagina clear of the viewing area. The vaginal speculum can be used with or without an illuminator. The ClearSpec® Single Use Vaginal Speculum is made available in various sizes from extra small to large to accommodate vagina cavity size.

    AI/ML Overview

    The provided text describes the 510(k) submission for the ClearSpec® Single-Use Vaginal Speculum. This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel AI or diagnostic device. Therefore, many of the requested elements are not applicable to this type of regulatory submission.

    Here's an attempt to answer the questions based on the provided text, indicating where information is not available or not applicable:

    1. Table of Acceptance Criteria and the Reported Device Performance

    Acceptance Criteria (Bench Testing)Reported Device Performance
    Sheath material ability to survive stresses encountered during use without failure"The results of the testing show the new device to perform as intended." (Implicitly, the sheath survives stresses)
    Sufficiency of sheath to speculum bond strength"sufficiency of sheath to speculum bond strength such that the sheath does not detach from the speculum during insertion, during the examination, or during withdrawal." (Implicitly, the bond strength is sufficient)
    Equivalence to predicate devices in performance"The results of the testing show the new device to perform as intended and equivalent to the predicate device."
    Biocompatibility per FDA GPM G95-1 and ISO 10993-1 for limited contact duration, surface contacting mucosal membrane device"found to be suitable for the intended use of this product."

    2. Sample size used for the test set and the data provenance

    • Sample size: Not explicitly stated. The text mentions "bench testing has been conducted using simulated actual use conditions" but does not quantify the number of tests or devices used.
    • Data provenance: Not explicitly stated, but based on the nature of bench testing, it would be internal lab data from ClearSpec LLC. It is prospective testing designed to evaluate the new device. Country of origin not specified, but the company is based in Boca Raton, FL, USA.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    Not applicable. This was bench testing, not a clinical study involving expert interpretation of medical data. The "ground truth" was based on established engineering and materials science principles, and the performance of the device itself under simulated conditions.

    4. Adjudication method for the test set

    Not applicable. Bench testing typically involves objective measurements and comparisons to predefined engineering specifications or predicate device performance, not expert adjudication in the manner of diagnostic performance studies.

    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 is a medical device (vaginal speculum) and not an AI or diagnostic imaging device. Therefore, MRMC studies are not relevant.

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

    Not applicable. This device does not involve an algorithm.

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

    The ground truth for the bench testing was based on:

    • Engineering specifications and material properties (e.g., strength, durability, bond integrity).
    • Established regulatory standards for biocompatibility (FDA GPM G95-1 and ISO 10993-1).
    • Comparison to the performance of predicate devices which are already deemed safe and effective.

    8. The sample size for the training set

    Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

    Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1