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510(k) Data Aggregation

    K Number
    K993544
    Device Name
    SPACE-OR RETRACTOR
    Manufacturer
    ADVANCED SURGICAL CONCEPTS (ASC)
    Date Cleared
    1999-12-22

    (64 days)

    Product Code
    FFO
    Regulation Number
    876.4730
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SPACE-OR RETRACTOR

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

    The Space-OR Retractor is a flexible internal retractor intended for the retraction of organs and tissues during abdominal surgery.

    Device Description

    The Space-OR is a flexible retractor which can be formed by the user into the desired shape for retraction of organs or tissues during abdominal surgery. The Space-OR can be left in position for a complete abdominal procedure.

    In the relaxed position, the Space-OR is malleable and can be placed along a wound edge or in the abdominal cavity. The device can be shaped around the desired organs forming an optimum retractor. The Space-OR includes a connector for wall vacuum. When vacuum is pulled, the device then solidifies, staying in the position formed by the user. The Space-OR will maintain its shape, retracting the desired organs or areas until the clamp is released.

    The vacuum applied to the Space-OR must be greater than 150 mmHg for the device to become solid. Once applied, the evacuation tubing is clamped and the vacuum pump removed. The device may be maintained in place for the duration of the surgery. If desired, the user can release the clamp on the vacuum, reposition the Space-OR and re-apply the vacuum.

    AI/ML Overview

    The provided text describes a 510(k) summary for the Advanced Surgical Concepts Space-OR Retractor, a manual surgical instrument. It is exempt from providing detailed performance testing results typically seen in AI/ML device submissions. Therefore, many of the requested details related to acceptance criteria, ground truth, and expert evaluation are not available in this document.

    However, based on the information provided, here's a summary of the available "acceptance criteria" and "study" information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implied)Reported Device Performance
    Maintain solid state at >150 mmHg vacuum"The vacuum applied to the Space-OR must be greater than 150 mmHg for the device to become solid. Once applied, the evacuation tubing is clamped and the vacuum pump removed. The device may be maintained in place for the duration of the surgery."
    Biocompatibility"The patient-contacting materials used in the Space-OR have been subjected to and passed biocompatibility testing according to ISO-10993."
    Function as intended in vivo (animal model)"Animal testing has been performed showing that the Space-OR functions as intended."
    No adverse effects/complications in clinical use"Additionally, the Space-OR has been in commercial distribution in Europe for over nine years with no complications or adverse effects."

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

    • Animal Testing: The document states "Animal testing has been performed," but does not specify the number of animals or the exact study design.
    • Clinical Use in Europe: "in commercial distribution in Europe for over nine years." No specific "test set" size is provided; this refers to real-world usage. The data provenance is described as clinical use in Europe, which is retrospective.

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

    Not applicable. This device is a manual surgical instrument, not an AI/ML imaging device requiring expert ground truth for image interpretation. The "ground truth" for its performance is its physical function and clinical safety.

    4. Adjudication Method for the Test Set

    Not applicable. No expert review leading to adjudication is mentioned for this type of device.

    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 not an AI/ML device, and no MRMC study information is provided.

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

    Not applicable. This is not an AI/ML device.

    7. The Type of Ground Truth Used

    • Bench Testing: The ability to "become solid" at a specified vacuum level would have been verified through bench testing.
    • Biocompatibility Testing: Performed per ISO-10993 standards.
    • Functionality: Assessed in animal models.
    • Safety/Effectiveness: Observed via "no complications or adverse effects" during nine years of commercial distribution in Europe.

    8. The Sample Size for the Training Set

    Not applicable. This is not an AI/ML device, so there is no "training set."

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

    Not applicable. There is no training set for this device.

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