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510(k) Data Aggregation

    K Number
    K151250
    Device Name
    Smart Set
    Manufacturer
    TOPSPINS, INC.
    Date Cleared
    2016-06-07

    (392 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Smart Set

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

    This product is intended to be used in an MR environment for the Administration of Contrast and Flush for Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography (MRA).

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for the "Smart Set" intravascular administration set. This document does not describe or contain information about acceptance criteria, a study that proves a device meets acceptance criteria, or any of the detailed study parameters requested (sample size, expert qualifications, ground truth, MRMC study, standalone performance, etc.).

    The letter is a regulatory document confirming that the FDA has reviewed the device and determined it is substantially equivalent to a legally marketed predicate device. It specifies the device name, models, regulation number, regulatory class, and indications for use. It also outlines general compliance requirements.

    Therefore, I cannot provide the requested information based on the given input text. The information needed to answer the prompt (acceptance criteria, study details, performance data) is not present in this regulatory approval letter.

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    K Number
    K972663
    Device Name
    SMART SET
    Manufacturer
    TOPSPINS, INC.
    Date Cleared
    1997-09-02

    (56 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SMART SET

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

    This product is intended to be used to assist in : the administration of fluids into a patient's vascular system during a Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography (MRA) examination.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) summary for the "Smart Set" device does not contain information about acceptance criteria, device performance metrics, or details of a study that proves the device meets specific criteria. The document is primarily a letter of substantial equivalence from the FDA, indicating that the device can be marketed.

    Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment based on the provided input.

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