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510(k) Data Aggregation

    K Number
    K091240
    Device Name
    ALPHAMED SURGICAL SPEAR, MODEL 70-5000
    Manufacturer
    ALPHAMED INC.
    Date Cleared
    2009-10-23

    (179 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ALPHAMED SURGICAL SPEAR, MODEL 70-5000

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

    AlphaMed Surgical Spears are intended to absorb fluids from the operative field during ophthalmic surgery

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for the AlphaMed™ Surgical Spear, and it primarily focuses on regulatory approval and substantial equivalence to a predicate device.

    The document does not contain details about:

    • A table of acceptance criteria or reported device performance.
    • Sample sizes for test sets or data provenance.
    • Number or qualifications of experts for ground truth establishment.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone (algorithm only) performance studies.
    • Types of ground truth used.
    • Sample size for the training set.
    • How ground truth for the training set was established.

    This document is a regulatory communication, not a scientific study report.

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