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510(k) Data Aggregation

    K Number
    K213255
    Device Name
    CipherOx CRI Tablet
    Manufacturer
    Flashback Technologies, Inc.
    Date Cleared
    2022-06-17

    (260 days)

    Product Code
    PPW
    Regulation Number
    870.2200
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CipherOx CRI Tablet

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    DEN160020
    Device Name
    CipherOx CRI Tablet
    Manufacturer
    Flashback Technologies, Inc.
    Date Cleared
    2016-12-21

    (211 days)

    Product Code
    PPW
    Regulation Number
    870.2200
    Type
    Direct
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K081285
    Why did this record match?
    Device Name :

    CipherOx CRI Tablet

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

    The CipherOx CRI Tablet is indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor), and the Compensatory Reserve Index (CRI), which trends changes in intravascular volume relative to the individual patient's response to hypovolemia.

    For patients with a finger thickness of 0.3" to 1" in hospital and pre-hospital settings.

    CRI trends with changes in intravascular volume relative to the individual patient's response to hypovolemia, and should only be used by qualified medical providers as an adjunct to rather than as a replacement for traditional hemodynamic measures. CRI is indicated for adults (19-36 years old) in the supine position under non-motion conditions and without cardiovascular disease. CRI has not been studied in trauma patients.

    Device Description

    The CipherOx CRI Tablet consists of a Nonin Onyx II Model 9560 finger pulse oximeter (previously cleared under K081285) that communicates by Bluetooth with a Cybernet CyberMed T10 tablet PC. The CipherOx CRI Tablet is a continuous, multi-parameter monitor that displays SpO2, Heart Rate (HR), photoplethysmograph (PPG) waveform images, and the Compensatory Reserve Index (CRI) value and historical trend-line.

    CRI is an index related to the physiologic changes induced by intravascular fluid loss and ranges from 0 to 1, where 1 indicates a normal subject and 0 indicates a subject who has undergone significant physiological effects from loss of fluid volume.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the CipherOx CRI Tablet, based on the provided text:

    Acceptance Criteria and Device Performance

    The core acceptance criterion for the CipherOx CRI Tablet appears to be the accurate estimation of CRI values, specifically the root-mean-squared error (RMSE) between estimated and reference CRI.

    Acceptance CriteriaReported Device Performance
    RMSE between estimated CRI and reference CRI should be less than 0.1The verification study showed the root-mean-squared error between the estimated CRI and reference CRI according to the LBNP level to be less than 0.1.
    CRI estimates are statistically similar across multiple devicesEach of four CipherOx CRI Tablets gave statistically similar CRI estimates.
    Turning the device on/off has no significant effect on CRI estimatesTurning the CipherOx CRI Tablets on and off during the study had no significant effect on CRI estimates.
    High correlation between CRI and volume of blood removed during a blood draw studyIt was shown that there was a high correlation between CRI and volume of blood removed.
    Symptomatic subjects reaching lower CRI values during blood lossThe symptomatic group of subjects reached much lower CRI values than those who completed the blood removal without symptoms.

    Study Information

    2. Sample size used for the test set and the data provenance:

    • LBNP Verification Study: 20 healthy participants.
      • Data Provenance: The text does not explicitly state the country of origin, but the development and studies seem to be conducted by Flashback Technologies in Boulder, Colorado. The data is prospective, gathered specifically for the study.
    • Blood Draw Validation Study: 42 healthy participants (ages 19 to 36).
      • Data Provenance: Similar to the LBNP study, the country of origin is not explicitly stated but implied to be the US. The data is prospective, gathered specifically for the study.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    The text does not mention the use of experts to establish a "ground truth" in the traditional sense (e.g., diagnosis by radiologists). Instead, the ground truth for CRI was established physiologically:

    • LBNP Study: Reference CRI values were defined as CRI = 1 - LBNPcurrent / LBNPcollapse, where LBNPcollapse refers to the LBNP pressure level at the point a subject either had a precipitous fall in systolic blood pressure below 80 mmHg and/or voluntary subject termination due to discomfort or expression of presyncopal symptoms (or until completion of -100 mmHg). This relies on objective physiological measurements (blood pressure) and subjective patient reporting (presyncopal symptoms).
    • Blood Draw Study: The "ground truth" for the blood draw study was the actual volume of blood removed and the observation of symptoms (e.g., systolic blood pressure
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