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510(k) Data Aggregation

    K Number
    K040727
    Device Name
    CRYO 5
    Manufacturer
    ZIMMER ELEKTROMEDIZIN GMBH
    Date Cleared
    2004-04-23

    (32 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CRYO 5

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

    The Cryo 5 Cold Air Device is intended, to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.

    Device Description

    The Cryo 5 consists of a refrigeration unit that creates cold air. The cold air is blown onto the skin using an air hose.

    AI/ML Overview

    The provided text is a 510(k) summary for the Zimmer Cryo 5 device, which is a skin refrigerant. This document is a premarket notification to the FDA for market clearance and not a study report detailing acceptance criteria and performance against those criteria. As such, the input does not contain the information requested regarding acceptance criteria and a study proving the device meets them.

    Specifically, the document states:

    • "Performance Standards: None established (as a medical device) under section 514." This indicates that there are no specific performance standards or acceptance criteria defined by a regulatory body for this type of device.
    • "Summary of Substantial Equivalence: The Zimmer Cryo 5 is substantially equivalent to the compared devices on the basis of similarities in operating principles, intended use and functional performance." The 510(k) process relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study.

    Therefore, I cannot extract the following information because it is not present in the provided text:

    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 performance study 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
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