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510(k) Data Aggregation

    K Number
    K964364
    Device Name
    DISPOSABLE APRON
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Date Cleared
    1997-02-25

    (116 days)

    Product Code
    LYU
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K955835
    Why did this record match?
    Device Name :

    DISPOSABLE APRON

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

    The Disposable Apron will be used in indications which are the same for that of other aprons. Specifically, the Disposable Apron is intended to be used the hospital environment to protect the healtheare worker from the transfer of micro-organisms. blood, body fluids and particulate material between the worker and the patient. The Disposable Apron is a disposable product intended for single use only.

    Device Description

    The Disposable Apron is manufactured from 6 gauge Poly Vinyl and is available in a "onc size fits most" size The apron is secured by heing slipped over the head and tied in back

    AI/ML Overview

    The provided text describes the acceptance criteria and the study for a Disposable Apron manufactured by Instrument Makar, Inc. The study focuses on viral penetration testing.

    Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria for Viral Penetration (ASTM Method F1671-95) based on the K955835 Fluid Barrier Boot study:

    MetricAcceptance CriteriaReported Device Performance
    Viral PenetrationNo oX174 bacteriophage detected on the assay plates after challenge. (Based on passing results of Fluid Barrier Boot, which uses the same material)Thirty-two (32) samples of the Fluid Barrier Boot (made from the same 6-gauge embossed Poly-Vinyl as the apron) were tested. All thirty-two passed, showing no oX174 on the assay plates after being challenged with a oX174 bacteriophage suspension at a concentration of approximately 1.3 x 108 PFU/ml.
    Compatibility RatioCompatibility ratio for the material and test organisms should be acceptable to ensure the integrity of the test. (The text implies this was met for the Fluid Barrier Boot study, which is referenced for the apron's material).The compatibility ratio for the Fluid Barrier Boot was 1.3.
    Challenge LevelThe oX174 bacteriophage challenge suspension must be maintained at a concentration of at least 1.0 X 108 PFU/ml.The challenge level was maintained at ~1.3 x 108 PFU/ml.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size for the Test Set: 32 samples (referred to as "Fluid Barrier Boot" samples, which are made from the same material as the apron).
    • Data Provenance: The document does not specify the country of origin of the data. It appears to be an internal study conducted to support a 510(k) submission, suggesting it's retrospective as per common regulatory processes where testing precedes submission.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

    N/A. This study involves non-clinical testing (viral penetration testing) of a material, not human interpretation or diagnosis. Therefore, there are no "experts" establishing a ground truth in the traditional sense of clinical studies. The "ground truth" is determined by laboratory assay results (presence/absence of bacteriophage).

    4. Adjudication Method for the Test Set

    N/A. As stated above, this is laboratory testing, not a clinical study involving human interpretation. The outcome (presence/absence of bacteriophage) is determined by objective laboratory assays.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No. This is a non-clinical, material-level performance study, not a clinical MRMC study involving human readers or comparative effectiveness with or without AI.

    6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

    N/A. This is a non-clinical material test, not an algorithm performance study.

    7. The Type of Ground Truth Used

    The ground truth used is objective laboratory assay results for the presence or absence of the oX174 bacteriophage following a controlled challenge. This is a direct measurement of viral penetration through the material.

    8. The Sample Size for the Training Set

    N/A. This is a non-clinical performance test for a physical product (apron material), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

    9. How the Ground Truth for the Training Set Was Established

    N/A. As there is no training set for an AI algorithm, this question is not applicable.

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