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510(k) Data Aggregation

    K Number
    K963470
    Device Name
    CRISS-CROSS VEST RESTRAINT
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Date Cleared
    1996-11-14

    (72 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DeRoyal Industries, Inc. Criss-Cross Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movements thereby enabling examination or protection of the patient on others. The Criss-Cross Vest Restraint is a protective restraint that is intended to be used with a bed or wheelchair.

    Device Description

    The DeRoyal Industries, Inc. Criss-Cross Vest Restraint device that is intended for medical purposes to limit patient movements thereby enabling examination or protection of the patient or others. Device Design/Materials UsedPhysical Properties: The DeRoyal Criss-Cross Vest Restraint is designed similar to those marketed by other manufacturers. The Criss-Cross Vest Restraint is primarily comprised of cool knit, cotton, or plaid tietex with polyester straps. The fasteners are made of a nylon hook and loop, plastic, or steel nickel plated buckles.

    AI/ML Overview

    This document is a 510(k) summary for a medical device called the "DeRoyal Industries, Inc. Criss-Cross Vest Restraint." It's a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

    The information provided does not describe a study conducted to demonstrate the device meets acceptance criteria in the way described in your request (e.g., a clinical trial with performance metrics like sensitivity/specificity). Instead, it's a demonstration of substantial equivalence based on technological characteristics.

    Therefore, many of the requested fields are not applicable to this type of submission. I will indicate "Not Applicable (N/A)" for those fields.

    Here's the breakdown based on the provided text:

    1. A table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    Functional Equivalence to Predicate Device: The device must limit patient movements for examination or protection, and be intended for use with a bed or wheelchair.The DeRoyal Criss-Cross Vest Restraint is described as "a device that is intended for medical purposes to limit patient movements thereby enabling examination or protection of the patient or others." It is "intended to be used with a bed or wheelchair." This aligns with the stated function of similar marketed devices.
    Material Equivalence to Predicate Device: Materials used should be comparable to predicate devices."Primarily comprised of cool knit, cotton, or plaid tietex with polyester straps. The fasteners are made of a nylon hook and loop, plastic, or steel nickel plated buckles." This is explicitly stated as "Same" as Other Devices in the technological comparison table.
    Size Offering Equivalence to Predicate Device: Available in similar sizes as predicate devices."Small, Medium, Large, X-Large, XX-Large." This is explicitly stated as "Same" as Other Devices in the technological comparison table.
    Intended Use Equivalence to Predicate Device: Indicated for similar use cases and patient activity levels as predicate devices.Indicated "to limit patient movements thereby enabling examination or protection of the patient on others." For "Mildly agitated or disoriented" patients. This is explicitly stated as "Same" as Other Devices regarding "Level of Patient Activity" and "Length of use" implications (doctor must prescribe every 24 hours).

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Sample Size: N/A - No "test set" in the context of evaluating a performance metric (e.g., sensitivity/specificity) was used. The submission focuses on a comparison of design and intended use with existing devices.
    • Data Provenance: N/A - Not applicable for a substantial equivalence claim based on technological characteristics.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    • Number of Experts: N/A
    • Qualifications of Experts: N/A

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Adjudication method: N/A

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • MRMC Study: No, this is not applicable for a physical patient restraint device.
    • Effect Size: N/A

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • No, this is a physical device, not an algorithm.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    • Ground Truth: N/A - The "ground truth" in this context is the established safety and effectiveness of the predicate devices and the technological characteristics that define them. The submission asserts that the new device shares these characteristics.

    8. The sample size for the training set

    • Sample Size: N/A - No "training set" in the context of machine learning or algorithm development.

    9. How the ground truth for the training set was established

    • Ground Truth Establishment: N/A
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