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510(k) Data Aggregation

    K Number
    K223596
    Device Name
    SQ.line KERRISON
    Manufacturer
    Aesculap Inc.
    Date Cleared
    2023-06-29

    (209 days)

    Product Code
    HAE
    Regulation Number
    882.4840
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K153243
    Why did this record match?
    Device Name :

    SQ.line KERRISON

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

    The SQ.line KERRISONS (bone punches) are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.

    Device Description

    The SQ.line KERRISON bone punches are reusable surgical instruments made out of stainless are coated with Medthin™ 42 DLC. The bone punches are available with the following features: shaft lengths 180 - 280 mm, bite sizes 1 - 6 mm, jaw openings 10 - 15 mm, cutting angles 90° and 130° up/down, standard and thin profile footplates and semi-detachable or fully detachable with an ejector.

    AI/ML Overview

    This document describes the premarket notification (510(k)) for the SQ.line KERRISON manual rongeur. It outlines the device's indications for use, its substantial equivalence to a predicate device, and the non-clinical testing performed to demonstrate its safety and effectiveness.

    Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test PerformedAcceptance CriteriaReported Device Performance
    Cutting TestNot explicitly stated in detail, but implied to ensure effective cutting after a specified number of uses."The test performed confirmed the acceptance criterias were met." (after 25,000 cuttings)
    Performance Test (Cutting Force)Implied to define an acceptable range of force required to cut."The test performed showed that the applied force meets the acceptance criteria."
    Mechanical Performance after ReprocessingImplied to ensure the device maintains functionality and integrity after reprocessing."The mechanical performance was assessed after reprocessing and met the acceptance criteria."
    BiocompatibilityCompliance with ISO 10993 standards for chemical characterization, cytotoxicity, sensitization, irritation, and acute systemic toxicity."Test results indicate that the SQ.line KERRISONS are biocompatible."

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

    The document does not explicitly state the sample size (number of devices or tests performed per device) for the cutting test, performance test, or mechanical performance after reprocessing.

    For biocompatibility, the sample size or specific test article numbers are not provided.

    The data provenance is not specified (e.g., country of origin). The studies appear to be internal non-clinical evaluations conducted by the manufacturer, Aesculap, Inc. All studies are retrospectively performed as part of the 510(k) submission process.

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

    This information is not applicable as the studies described are non-clinical, mechanical, and biocompatibility tests, not studies requiring expert interpretation or ground truth establishment in the human diagnostic context.

    4. Adjudication Method for the Test Set

    This information is not applicable as the studies described are non-clinical tests and do not involve human adjudication.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

    This information is not applicable. The device is a manual surgical instrument (rongeur), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    This information is not applicable. The device is a manual surgical instrument, not an algorithm.

    7. The Type of Ground Truth Used

    For the cutting test, performance test, and mechanical performance after reprocessing, the "ground truth" is established by engineering specifications and predefined performance thresholds based on the device's intended function and safety requirements.

    For biocompatibility, the "ground truth" is established by compliance with internationally recognized standards (ISO 10993).

    8. The Sample Size for the Training Set

    This information is not applicable. The device is a manual surgical instrument and does not involve AI or machine learning algorithms that require a "training set."

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

    This information is not applicable as there is no training set for this type of device.

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