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    K Number
    K030650
    Device Name
    STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS
    Manufacturer
    URIDYNAMICS, INC.
    Date Cleared
    2003-04-14

    (45 days)

    Product Code
    CEN,JJW,JRE
    Regulation Number
    862.1550
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    K961374,K971976
    Why did this record match?
    Device Name :

    STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS

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

    UriDynamics StoneGuard™ II Test Strips are intended for semiquantitative measurement of pH and specific gravity in fresh urine. They can be used to monitor conditions that may cause the formation of kidney stones, namely trends in urinary pH and hydration status.

    Confirm Low™ and Confirm High™ Control Solutions are intended for in vitro (external) use only, for use as control materials for StoneGuard™ II Test Strips only.

    Device Description

    UriDynamics StoneGuard™ II Test Strips consist of plastic carriers with two reagent pads attached. The pads respond to pH and specific gravity. StoneGuard™ II Test Strips are stored in an opaque vial with desiccant and are ready to use. Results may be read between 30 and 60 seconds after wetting with a freshly-voided urine sample. Results are obtained by comparing the color developed on the pads with a printed color chart. The results are semi-quantitative. Control solutions, Confirm Low™ and Confirm High™, intended for use with StoneGuard™ II Test Strips, are also included in this submission. Confirm Low™ and Confirm High™ contain buffers and salts that give a known response with StoneGuard™ II Test Strips. Confirm Low™ and Confirm High™ Control Solutions are ready to use in dispensers, and contain no biological ingredients.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implied by the "Accuracy" and "Correlation of Consumer & Reference Results" sections. The reported performance refers to the results obtained in the studies.

    Acceptance Criteria (Implied)Reported Device Performance (StoneGuard™ II)
    pH Accuracy100% of results within one-half color block of the expected value.
    pH Correlation (Consumer)92.5% of participant results within ± one-half pH unit of the reference value.
    Specific Gravity AccuracyAt least 75% of results within one-half color block of the expected value.
    Specific Gravity Correlation (Consumer)92.5% of participant results within ±0.010 of the reference.

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

    • Sample Size for Test Set: 107 participants for the clinical studies.
    • Data Provenance: The study was conducted at four sites in Indiana, USA. The data is prospective, as it involved recruiting participants for a "Clinical Studies" section, indicating data collected specifically for the purpose of this evaluation.

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

    The document does not explicitly state the number of experts or their qualifications for establishing ground truth. Instead, it refers to "reference results obtained by refractometer for specific gravity and pH meter for pH" (for specificity, Corning Model 313 pH Meter and eclipse Handheld Refractometer). This suggests that established laboratory instruments served as the "ground truth" rather than human experts.

    4. Adjudication Method for the Test Set

    The document does not describe any human adjudication method (e.g., 2+1, 3+1). The ground truth was established by laboratory instruments.

    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

    There was no MRMC comparative effectiveness study involving AI mentioned in the document. This device is a visual reagent test strip, not an AI-powered diagnostic. The study focused on assessing untrained consumers' ability to interpret results visually compared to reference instruments.

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

    This is not applicable, as StoneGuard™ II is a visual test strip requiring human interpretation, not an algorithm. The "standalone" performance here refers to the performance of the chemical pads themselves responding to pH and specific gravity, which was tested for accuracy and precision against reference instruments.

    7. The Type of Ground Truth Used

    The ground truth used was instrument-based reference values.

    • For pH: Readings from a Corning Model 313 pH Meter.
    • For specific gravity: Readings from an eclipse Handheld Refractometer.

    8. The Sample Size for the Training Set

    The document does not mention a "training set" in the context of machine learning or algorithm development, as this is a chemical reagent strip. The studies described are for validation of the final product.

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

    Not applicable, as there is no training set in the context of this device. The "ground truth" for the performance evaluation was established by laboratory instruments as described in point 7.

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