LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K060172
    Device Name
    REMA SHAVER BLADES
    Manufacturer
    REMA MEDIZINTECHNIK GMBH.
    Date Cleared
    2006-05-31

    (128 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K023777,K953695,K955914,K901735,K963332,K943985,K990524,K041824,K030009
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMA MEDIZINTECHNIK GMBH.

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

    The REMA Shaver Blades are intended to provide shaving, cutting and abrading of bone and tissue during arthroscopic surgical procedures conducted by qualified surgeons.

    Device Description

    The REMA Shaver Blades consists of an outer tube with a hub and a rotating inner tube with a connector. The inner and outer tube consists of stainless steel. The hub and connector can consist of stainless steel or Polyphenylsulfone (PPSU). The components are designed and intended to be operated exclusively as a unit.

    AI/ML Overview

    The provided text describes a 510(k) summary for REMA Shaver Blades, which is a medical device. However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert involvement, or any of the other specific details requested in your prompt.

    The document primarily focuses on:

    • Identification of the device and applicant.
    • Classification and proprietary names.
    • Identification of predicate devices.
    • Description of the device's components and materials.
    • Intended use/indications.
    • A general statement about safety and substantial equivalence based on material selection and similarity to predicate devices.
    • The FDA's decision letter regarding substantial equivalence.

    Therefore, I cannot provide the requested table and study details as they are not present in the given text.

    The table below reflects that the requested information is not available in the provided document.

    Information CategoryDetails from provided document
    1. Acceptance Criteria and Device PerformanceNot provided. The document states: "Biocompatibility, function, indications and designs have been developed to ensure the safety of this device and it is substantially equivalent to commercially approved shaver systems available for sale in the USA." No specific acceptance criteria or performance metrics are reported.
    2. Sample Size (Test Set) & Data ProvenanceNot provided. No performance study is described.
    3. Number & Qualifications of ExpertsNot provided. No performance study involving experts for ground truth is described.
    4. Adjudication MethodNot provided. No ground truth adjudication process is described.
    5. MRMC Comparative Effectiveness StudyNo. This device is a surgical tool, not an AI or imaging diagnostic device where MRMC studies are typically conducted. No such study is mentioned.
    6. Standalone Algorithm PerformanceNo. This device is a physical surgical tool, not an algorithm. No standalone performance study is described.
    7. Type of Ground Truth UsedNot applicable. No ground truth was established as no performance study is described. The approval is based on substantial equivalence to predicate devices and material biocompatibility.
    8. Sample Size for Training SetNot applicable. This is a physical device, not an AI model requiring a training set.
    9. Ground Truth for Training SetNot applicable. This is a physical device, not an AI model requiring a training set.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1