LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K163206
    Device Name
    SMD-Sr90-DA Radionuclide Brachytherapy Source
    Manufacturer
    Salutaris Medical Devices, Inc.
    Date Cleared
    2016-12-15

    (30 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Salutaris Medical Devices, Inc.

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

    The SMD-Sr90-DA Radionuclide Brachytherapy Source is indicated for episcleral brachytherapy. The SMD-Sr90-DA RBS device is intended for use within a manual brachytherapy applicator system.

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but this document (K163206) does not contain the information requested. This document is an FDA clearance letter for a medical device (SMD-Sr90-DA Radionuclide Brachytherapy Source) and includes regulatory information and indications for use. It does not provide details about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert qualifications as it pertains to AI/algorithm performance. These elements are typically found in study reports or 510(k) summaries for devices incorporating artificial intelligence or machine learning.

    Ask a Question

    Ask a specific question about this device

    K Number
    K142701
    Device Name
    SMD Sr90-1 Radionuclide Brachytherapy Source
    Manufacturer
    Salutaris Medical Devices, Inc.
    Date Cleared
    2014-12-19

    (88 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Salutaris Medical Devices, Inc.

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

    The SMD Sr90-1 Radionuclide Brachytherapy Source is indicated for episcleral brachytherapy of tumors and benign growths.

    The SMD Sr90-1 RBS device is intended for use within a manual brachytherapy applicator system.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Salutaris Medical Devices, Inc. SMD Sr90-1 Radionuclide Brachytherapy Source. It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information regarding specific acceptance criteria, device performance metrics, or the details of a study (test set, training set, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) that proves the device meets any such criteria.

    The letter focuses on regulatory approval and compliance, not on performance evaluation studies. Therefore, I cannot construct the requested table or answer the specific questions about sample sizes, data provenance, expert ground truth, or study methodologies based on the input provided.

    The document only indicates the "Indications for Use" for the device: "The SMD Sr90-1 Radionuclide Brachytherapy Source is indicated for episcleral brachytherapy of tumors and benign growths. The SMD Sr90-1 RBS device is intended for use within a manual brachytherapy applicator system."

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1