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510(k) Data Aggregation

    K Number
    K162153
    Device Name
    Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System
    Manufacturer
    ASCENSION ORTHOPEDICS
    Date Cleared
    2017-07-14

    (346 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K090675,K082320,K060026
    Why did this record match?
    Reference Devices :

    HWC, K090675, K082320, K060026

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

    The proposed indications for use for the Integra® CAPTURE™ Screw System are as follows:
    "The CAPTURE™ Screw System implants (screws) are intended for fixation of fractures, and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.

    The proposed indications for use for the Integra® Ti6® Internal Fixation System are as follows: "The Ti6@ Internal Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.

    Device Description

    The Integra® CAPTURETM Screw System and Integra® Ti6® Internal Fixation System consists of bone screws of various designs and sizes intended to fixate bones in cases of fractures, osteotomies, or fusions. The screws are self- drilling and self-tapping, and are manufactured from Ti-6Al-4V titanium alloy. This submission presents new cannulated (Digital Fusion) and non-cannulated (QuickSnap) screw designs that are line extensions to the current Integra® CAPTURE™ Screw System and Integra® Ti6® Internal Fixation System.

    AI/ML Overview

    This document is a 510(k) premarket notification for the Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System. It describes the device, its intended use, and the basis for substantial equivalence to predicate devices. Crucially, as a 510(k) submission, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving novel effectiveness through clinical trials.

    The document states:
    "Clinical Performance Data: Clinical performance data was not necessary to demonstrate substantial equivalence."

    Therefore, the specific information requested about acceptance criteria for device performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details will not be available in this document as it explicitly states clinical performance data was not required or provided.

    However, I can provide the non-clinical performance data and its findings, which were used to establish substantial equivalence.

    1. Table of Acceptance Criteria and Reported Device Performance

    TestAcceptance Criteria (Implied by Substantial Equivalence to Predicate)Reported Device Performance
    Torsional StrengthSubstantially equivalent or better than predicate devicePerformed substantially equivalent or better than predicate device
    Driving TorqueSubstantially equivalent or better than predicate devicePerformed substantially equivalent or better than predicate device
    Axial Pullout StrengthSubstantially equivalent or better than predicate devicePerformed substantially equivalent or better than predicate device

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

    • Test Set Sample Size: Not specified in the document for the non-clinical tests.
    • Data Provenance: The tests were conducted "per ASTM F543," which is a standard for metallic bone screws. This indicates laboratory testing, not human patient data.

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

    • Not applicable. The ground truth for mechanical testing is based on established engineering standards (ASTM F543) and physical measurements, not expert human interpretation.

    4. Adjudication method for the test set:

    • Not applicable as the testing involves direct physical measurements against engineering standards rather than subjective interpretations requiring adjudication.

    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:

    • No. A MRMC comparative effectiveness study was not done. This device is a bone fixation screw system, not an AI or imaging diagnostic device that would involve human readers or AI assistance in interpretation.

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

    • No. This device is a physical medical device (screws), not an algorithm or software. Standalone performance as an algorithm is not applicable.

    7. The type of ground truth used:

    • Non-clinical performance data: Ground truth was established by adherence to ASTM F543 standards for mechanical properties (Torsional Strength, Driving Torque, Axial Pullout Strength) and comparison to predicate devices.

    8. The sample size for the training set:

    • Not applicable. This device is a physical medical implant, not an AI or machine learning model that requires a training set. The "training" for the device's design and manufacturing would come from engineering principles and standards.

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

    • Not applicable. See point 8.
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