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510(k) Data Aggregation

    K Number
    K091187
    Device Name
    GRACE DYNAMIC TORP
    Manufacturer
    Grace Medical, Inc.
    Date Cleared
    2009-09-14

    (144 days)

    Product Code
    ETA
    Regulation Number
    874.3495
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K972585,K080070,K061853
    Why did this record match?
    Device Name :

    GRACE DYNAMIC TORP

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

    An ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include:
    (a) Chronic middle ear disease,
    (b) Otosclerosis,
    (c) Congenital fixation of the stapes,
    (d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and
    (e) Surgically correctible injury to the middle ear from trauma.

    Device Description

    The Grace Dynamic Ossicular Replacement Prostheses are manufactured from the same materials as the predicate devices:
    (i) Unalloyed titanium (ASTM F67)
    (ii) Titanium alloy (ASTM F136)
    (iii) Medical Grade Silicone
    (iv) ASTM F1185 Hydroxylapatite

    AI/ML Overview

    The provided document is a 510(k) summary for the Grace Dynamic Ossicular Replacement Prostheses. This type of regulatory document focuses on establishing substantial equivalence to predicate devices based on intended use, materials, and technological characteristics. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way a clinical or performance study report for a diagnostic AI device would.

    Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, or training set details) because this document does not contain that type of data.

    The 510(k) summary states: "Differences between the Grace Dynamic Ossicular Replacement Prostheses and the predicate devices should not affect the safety or effectiveness." This statement, along with the comparison of materials and intended use to predicate devices, forms the basis of the "proof" for substantial equivalence in this context, rather than a detailed performance study with quantifiable acceptance criteria.

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