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510(k) Data Aggregation

    K Number
    K062898
    Device Name
    SBI LATERAL RHEAD IMPLANT
    Manufacturer
    SMALL BONE INNOVATIONS INC.
    Date Cleared
    2006-11-13

    (47 days)

    Product Code
    KWI
    Regulation Number
    888.3170
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SBi Lateral Assembly rHead is intended for replacement of the proximal end of the radius:

    1. Replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with:
      a. Joint destruction or subluxation visible on x-ray
      b. Resistance to conservative treatment
    2. Primary replacement after fracture of the radial head
    3. Symptomatic sequelae after radial head resection
    Device Description

    The SBi Lateral Assembly rHead prosthesis consists of a cobalt chromium stem and head. The stem of the implant is coated with CPTi coating and is designed to be inserted into the shaft of the proximal radius. The head of the implant articulates with the capitellum. The implant is available in several sizes, each of which can be used in right or left hands. A range of trial sizers for each type of implant is available to aid in bone preparation.

    AI/ML Overview

    This 510(k) premarket notification for the SBI Lateral rHead Implant for radial head replacement does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance.

    Instead, this document is a regulatory submission outlining the device description, intended use, and a declaration of substantial equivalence to legally marketed predicate devices. It also includes the FDA's clearance letter for the device.

    Therefore, I cannot extract the following information from the provided text:

    1. A table of acceptance criteria and the reported device performance: This document does not describe specific performance criteria or present results from a performance study.
    2. Sample size used for the test set and the data provenance: No test set is described.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is discussed.
    4. Adjudication method for the test set: No test set or adjudication is mentioned.
    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: This device is a physical implant, not an AI-assisted diagnostic tool, so an MRMC study related to AI assistance is not applicable.
    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a physical implant.
    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth for a study is described.
    8. The sample size for the training set: No training set is mentioned as this is not an AI/software device.
    9. How the ground truth for the training set was established: Not applicable.

    The document primarily focuses on establishing substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting a performance study with defined acceptance criteria.

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