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510(k) Data Aggregation

    K Number
    K960054
    Device Name
    900UDX URINE PATHOLOGY SYSTEM
    Manufacturer
    INTL. REMOTE IMAGING SYSTEMS
    Date Cleared
    1996-03-22

    (78 days)

    Product Code
    KQO
    Regulation Number
    862.2900
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    900UDX URINE PATHOLOGY SYSTEM

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

    The 900UDx Urine Pathology System performs routine urinalysis, including urine chemistry, specific gravity, and sediment microscopic examination.

    Device Description

    The 900UDx Urine Pathology System provides automatic sample handling for automated intelligent microscopy and improved data presentation and management. Specimens are aspirated by an autosampler rather than poured manually. Microscopic examination results are displayed on an independent ViewStation computer with higher image resolution, and operators can confirm and release reports off-line for enhanced convenience. Chemistry results from the external Boehringer Mannheim Hitachi CHEMSTRIP® Super UA Urine AnalyzerTM are automatically consolidated by the ViewStation for display and reporting.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the IRIS 900UDx Urine Pathology System:

    Summary of Device Performance and Acceptance Criteria

    The information provided describes the IRIS 900UDx Urine Pathology System as a device for automated urinalysis, including urine chemistry, specific gravity, and sediment microscopic examination. The study's primary goal was to demonstrate substantial equivalence to a predicate device, The Yellow IRIS Urinalysis Workstation.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implicit)Reported Device Performance (IRIS 900UDx)
    Equivalence in detection of RBC, WBC, squamous epithelial cells, pathologic casts, and yeast compared to predicate device.Found to be equivalent to the predicate device.
    Equivalence in reproducibility compared to predicate device.Found to be equivalent to the predicate device.
    Greater sensitivity for detection of renal epithelial cells compared to predicate device.Achieved (greater sensitivity reported).
    Greater sensitivity for detection of crystals compared to predicate device.Achieved (greater sensitivity reported).
    Greater overall detection of abnormal urines compared to predicate device.Achieved (greater overall detection reported).
    Suitability for intended use.Shown to be suitable for its intended use.

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

    • Sample Size: Not specified in the provided text.
    • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only states "Clinical Tests."

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

    • Number of Experts: Not specified.
    • Qualifications of Experts: Not specified.

    4. Adjudication Method for the Test Set

    • Adjudication Method: Not specified.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • Was one done? Not explicitly stated or detailed. The study compared the device's microscopic analysis performance to a predicate device. This implies a comparison of the device's output to the output of the predicate device, not necessarily a human reader study with and without AI assistance to measure reader improvement. The focus is on the device's performance attributes (detection, reproducibility, sensitivity).
    • Effect size of human reader improvement with AI vs. without AI assistance: Not applicable or not reported based on the provided text, as this type of MRMC study isn't clearly described.

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

    • Was one done? Yes, effectively. The study evaluated the "Microscopic analysis performance of the 900UDx Urine Pathology System" compared to a predicate device. This is a standalone performance evaluation of the device's analytical capabilities. The system itself performs "automated intelligent microscopy," implying an algorithm's role in differentiation and detection. The statement "operators can confirm and release reports off-line" suggests the device generates results independently before human review.

    7. Type of Ground Truth Used

    • Type of Ground Truth: The ground truth for the comparison was the performance of the "Yellow IRIS Urinalysis Workstation." This means the predicate device's results served as the reference standard against which the 900UDx was evaluated for equivalence and improved sensitivity. Indirectly, the predicate device itself would have been validated against some form of established diagnostic criteria or expert interpretation in its own development.

    8. Sample Size for the Training Set

    • Sample Size: Not specified. (It's unclear if there was a separate "training set" for the system's algorithm as the primary focus is on comparison to a predicate device, rather than de novo algorithm development and validation specified here).

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

    • How Established: Not specified. (As above, information on a specific training set and its ground truth establishment is not provided in the context of this 510(k) summary).
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