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510(k) Data Aggregation

    K Number
    K972815
    Device Name
    PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT
    Manufacturer
    Grace Medical, Inc.
    Date Cleared
    1997-10-08

    (72 days)

    Product Code
    ETB
    Regulation Number
    874.3450
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT

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

    Ossicular replacement prostheses are indicated for the function of the ossicular chain when a conductive hearing loss is present. Indications include

    • Chronic middle ear disease ●
    • . Otosclerosis
    • Congenital fixation of the stapes
    • Secondary surgical intervention to correct for a significant and persistent conductive . hearing loss from prior otologic surgery
    • Surgically correctible injury to the middle ear from trauma .
    Device Description

    Partial Ossicular Replacement Proshesis Total Ossicular Replacement Prostheses Porous Polyethylene Ossicular Replacement

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for ossicular replacement prostheses, not a study describing the acceptance criteria or performance of a device, particularly an AI-based device.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details from the provided text. The document is primarily administrative, confirming substantial equivalence to a predicate device and specifying indications for use.

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