LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K060085
    Device Name
    STRYKER SCOPE/INSTRUMENT HOLDER
    Manufacturer
    Stryker Endoscopy
    Date Cleared
    2006-04-27

    (106 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K000663
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Stryker Scope Holder is indicated for use in arthroscopic, nasal, abdominal and laparoscopic surgical procedures, including laparoscopic general surgery, thoracic surgery, and endoscopic surgery. The device is intended to hold endoscopes steady in a desired position during the previously mentioned procedures. In addition, the device allows for the rapid repositioning of these endoscopes, laparoscopes and accessories during these procedures.

    Device Description

    The Stryker Scope Holder is an endoscopic accessory, composed of aluminum, stainless steel, PVC and PEEK.

    AI/ML Overview

    The provided text describes a 510(k) summary for the Stryker Scope Holder, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving a device meets specific performance criteria in the way a clinical trial for a novel AI algorithm would.

    Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this document. The information provided is primarily related to regulatory approval based on demonstrating equivalence, not a performance study against predefined benchmarks.

    Here's how the requested information maps to the provided text, along with an explanation for categories that are not applicable:

    1. A table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    Safety and Effectiveness Equivalence: Substantially equivalent in terms of safety and effectiveness to currently marketed devices.Substantially Equivalent: The Stryker Scope Holder is substantially equivalent in terms of safety and effectiveness to the Kronner Low Profile Scope Holder (K000663). No new questions raised regarding safety or effectiveness.
    Compliance with Voluntary Standards: Adherence to specified safety and performance standards.Conforms to Standards: IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2, IEC 60601-1-4, UL 60601-1, EN 554. Nitrogen tank (UN1066) adheres to DOT 49 CFR 172.101 shipping requirements.
    Intended Use: Device performs as intended to hold and reposition endoscopes during various surgical procedures.Indicated Use: Intended to hold endoscopes steady and allow rapid repositioning in arthroscopic, nasal, abdominal, laparoscopic, general, and endoscopic surgical procedures.
    Technological/Performance Differences: No significant differences compared to the predicate device.No Significant Differences: There are no significant technological or performance differences between the Stryker Scope Holder and the identified predicate device.

    2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

    • Not Applicable. This document describes a 510(k) submission, which relies on demonstrating substantial equivalence to a predicate device, not on a performance study with a test set of data. Clinical data from human subjects or retrospective/prospective studies are not mentioned or required for this type of submission for this device.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

    • Not Applicable. Ground truth, in the context of expert consensus, is not relevant to this 510(k) submission. There is no mention of a test set requiring expert adjudication.

    4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

    • Not Applicable. No test set or expert adjudication method is mentioned or required for this 510(k) submission.

    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 document describes a physical medical device (scope holder), not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.

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

    • Not Applicable. This device is a physical tool, not an algorithm. Therefore, "standalone" performance in the context of AI algorithms is not relevant.

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

    • Not Applicable. For this 510(k) submission, "ground truth" as it relates to establishing the accuracy of a diagnostic or predictive algorithm is not applicable. The primary "truth" being established is that the device is substantially equivalent to a legally marketed predicate and is safe and effective for its intended use. This is achieved through engineering assessment, comparison to standards, and comparison to the predicate device, not through clinical ground truth data in the usual sense.

    8. The sample size for the training set

    • Not Applicable. This document describes a physical medical device, not a machine learning model that requires a training set.

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

    • Not Applicable. As there is no training set for a machine learning model, the establishment of ground truth for such a set is not applicable.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1