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510(k) Data Aggregation

    K Number
    K973975
    Device Name
    RESPIRTECHPRO
    Manufacturer
    VORTRAN MEDICAL TECHNOLOGY 1, INC.
    Date Cleared
    1998-06-12

    (235 days)

    Product Code
    BTL
    Regulation Number
    868.5925
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RESPIRTECHPRO

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

    The device is to be used by properly trained personnel to deliver emergency, short term, constant flow - pressure cycled ventilatory support.

    Device Description

    RespirTech PRO™ 2000 - Automatic Resuscitator

    AI/ML Overview

    Based on the provided text, there is no information regarding the acceptance criteria, study details, or performance of the RespirTech PRO™ - Automatic Resuscitator. The document is an FDA 510(k) clearance letter, which states that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

    Therefore, I cannot provide the requested information for the following points:

    1. A table of acceptance criteria and the reported device performance
    2. Sample sized used for the test set and the data provenance
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
    4. Adjudication method for the test set
    5. If a multi reader multi case (MRMC) comparative effectiveness study was done
    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
    7. The type of ground truth used
    8. The sample size for the training set
    9. How the ground truth for the training set was established

    The document primarily focuses on the regulatory clearance of the device rather than the specific details of performance testing or clinical studies.

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