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    K Number
    K173271
    Device Name
    Aesculap Slim Clip Applier Forceps
    Manufacturer
    Aesculap, Inc.
    Date Cleared
    2017-11-10

    (29 days)

    Product Code
    HCI
    Regulation Number
    882.4175
    Type
    Special
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K003519,K002871,K984109,K983758,K970050,K940970,K922272,K913765,K833651
    Why did this record match?
    Device Name :

    Aesculap Slim Clip Applier Forceps

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

    The Aesculap Slim Clip Applier forceps are used for opening, closing, and applying Aesculap YASARGIL aneurysm clips.

    Device Description

    The Aesculap Slim Clip Applier forceps are manufactured from stainless steel (body & jaw). The appliers are available in lengths ranging from 50 mm to 110 mm. In addition to the straight jaw configuration, the Clip Appliers are available with jaws angled up & down, left & right.

    Each Clip Applier is individually laser marked with the type of clip designated for use. In addition, identification plugs to easily identify each clip designation are placed in the handles.

    AI/ML Overview

    The Aesculap Slim Clip Applier is a medical device for opening, closing, and applying Aesculap YASARGIL aneurysm clips.

    Here's an analysis of its acceptance criteria and the study proving it meets these criteria:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (from "Performance Test completed" column in source)Reported Device Performance (from "Results" and "Conclusions" columns in source)
    Benchmark Functional Test:
    1. Meet required interface and opening width of the aneurysm clip.Pass. The devices interfaced successfully with the aneurysm clips while providing the correct opening width.
    2. Successful release of designated aneurysm clip in the craniotomy.Pass. In addition, the devices successfully released the aneurysm clips within the craniotomy.
    Predicate/Subject Device Comparison Test:
    Comparison between predicate and subject device ensuring:Pass. The performance testing demonstrated that the subject devices are substantially equivalent to the predicate devices.
    1. Required interface and opening width of designated aneurysm clip.(Implied by "Pass" and "substantially equivalent" conclusion).
    2. Successful release of aneurysm clip in the craniotomy.(Implied by "Pass" and "substantially equivalent" conclusion).
    Usability Test:
    1. Ensuring identification of designated clip type for the specific clip applier.Pass. The usability test demonstrated that the subject devices were properly identified and met the usability requirements.
    2. Legibility of additional Clip Applier identification features, i.e., company name, article number, and UDI information.Pass. (Implied by "Pass" and "met the usability requirements" conclusion).
    3. Ensuring visualization of surgical site.Pass. (Implied by "Pass" and "met the usability requirements" conclusion).
    4. Ability to grasp, hold, and apply YASARGIL Aneurysm Clip.Pass. (Implied by "Pass" and "met the usability requirements" conclusion).

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

    The document does not explicitly state the numerical sample size for the test set. It mentions "Bench testing results" and describes the types of tests performed. The data provenance is not explicitly mentioned (e.g., country of origin). The testing described is prospective bench testing focused on the mechanical and functional aspects of the device, rather than patient data.

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

    The document does not mention the use of experts to establish ground truth for the test set. The tests described are objective performance and usability assessments.

    4. Adjudication Method for the Test Set

    No adjudication method is mentioned, as the tests appear to be objective performance evaluations rather than subjective assessments requiring expert consensus.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    An MRMC study was not conducted as this device is a mechanical instrument (aneurysm clip applier) rather than an AI-powered diagnostic tool or image interpretation system. Therefore, there is no effect size reported for human readers with or without AI assistance.

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

    A "standalone" study in the context of an algorithm is not applicable here, as this is a physical medical device. The "standalone" performance would be analogous to the "Benchmark Functional Test" and "Predicate/Subject Device Comparison Test" which assess the device's inherent functional capabilities without direct human interaction beyond its intended use.

    7. The Type of Ground Truth Used

    The ground truth used for these tests is based on engineering specifications and functional requirements for aneurysm clip appliers, ensuring they correctly interface, open, close, and release aneurysm clips as intended, and meet usability standards.

    8. The Sample Size for the Training Set

    A "training set" is not applicable as this is a mechanical device, not an AI or machine learning model.

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

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

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