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    K Number
    K120412
    Device Name
    3M SPOTON TEMPERATURE MONITORING SYSTEM
    Manufacturer
    ARIZANT HEALTHCARE INC.
    Date Cleared
    2012-05-30

    (110 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K760948
    Why did this record match?
    Reference Devices :

    K760948

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

    Measure, monitor, and trend body temperature of adult and pediatric patients.

    Device Description

    The 3M™ SpotOn™ temperature monitoring system consists of a disposable sensor, a control unit, a power supply cord, and an optional interface cable that allows temperature data to be transmitted to a standard YSI-400 input on a vital signs monitor.

    AI/ML Overview

    Here's an analysis of the provided text regarding the 3M™ SpotOn™ temperature monitoring system, focusing on acceptance criteria and the study that proves the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state numerical acceptance criteria for the device's performance in terms of accuracy (e.g., a specific delta or range). Instead, it relies on a comparison to established standards and the substantial equivalence to a predicate device.

    Acceptance Criteria CategorySpecific Acceptance Criteria (Implied/Referenced)Reported Device Performance
    SafetyCompliance with applicable standards (e.g., IEC 60601-1, ISO 10993 for biocompatibility)Multiple tests confirmed safety and compliance.
    Effectiveness/AccuracySubstantial equivalence to predicate device (Thermo-Finer CoreTemp K760948); Agreement with reference clinical thermometers (oral/rectal); Performance referenced to ISO 80601-2-56 and ASTM E1965-98.Clinical data showed "substantial equivalence in the performance" to predicate device. Mean bias observed in any subgroup was "no worse than the bias between axillary and bladder temperatures." Agreement with predictive oral/rectal thermometry is "roughly equivalent to the agreement between direct or indirect tympanic thermometry and brain parenchyna or pulmonary artery blood temperature."
    Non-Clinical PerformanceCompliance with specific standards (e.g., ISO 80601-2-56, EN 12470-4, ASTM E1112-00, IEC 60601-1-2) for laboratory accuracy, time response, EMC, long-term stability, adhesive testing.Multiple tests performed to confirm compliance with these standards.

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

    • Sample Size for Test Set: Not explicitly stated in the provided text. The document mentions "method comparison trial design" and "mean bias observed in any subgroup," which implies a cohort of patients was included, but the specific number is omitted.
    • Data Provenance: The document does not specify the country of origin for the clinical trial data. It does state that the clinical tests were a "method comparison trial design," which generally implies prospective data collection, but this is not explicitly confirmed.

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

    • The document does not mention the involvement of experts for establishing ground truth in the clinical study. The reference temperature was obtained using "a standard clinical thermometer" at "either oral or rectal sites."

    4. Adjudication Method for the Test Set

    • Not applicable/Not mentioned. Ground truth was established by direct measurement with standard clinical thermometers, not by expert consensus requiring adjudication.

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

    • No, an MRMC comparative effectiveness study was not performed. The study described is a method comparison trial for device performance against traditional thermometers, not an evaluation of human readers with or without AI assistance.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    • Yes, the clinical "method comparison trial" evaluates the standalone performance of the 3M™ SpotOn™ system against reference thermometers. The device's output (temperature measurement) is directly compared to the reference measurement. There is no human interpretation of the device's output mentioned as part of this performance evaluation.

    7. The Type of Ground Truth Used

    • The ground truth used was direct measurement from standard clinical thermometers at either oral or rectal sites. This is a form of reference standard measurement.

    8. The Sample Size for the Training Set

    • Not applicable/Not mentioned. The 3M™ SpotOn™ temperature monitoring system is an electronic thermometer, not a machine learning or AI-based device that would typically have a "training set" in the context of algorithm development. Its function is based on direct-connection, zero-heat-flux thermometry.

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

    • Not applicable/Not mentioned, as there is no indication of a training set for an AI/ML algorithm.
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