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510(k) Data Aggregation

    K Number
    K052829
    Device Name
    WRISTOX MODEL 3100 PULSE OXIMETER
    Manufacturer
    NONIN MEDICAL, INC.
    Date Cleared
    2005-11-10

    (36 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    K033307,K030668
    Why did this record match?
    Device Name :

    WRISTOX MODEL 3100 PULSE OXIMETER

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

    The Nonin® Model 3100 WristOx® Pulse Oximeter is a small wrist-worn device indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is intended for spot-checking and / or data collection and recording of patients during both no motion and motion conditions, and for patients who are well or poorly perfused.

    Device Description

    The Nonin Model 3100 WristOx® is a small wrist-worn pulse oximeter. It has an electro-optical sensor that determines the light absorption of functional arterial hemoglobin. It is used to spot check patients, or it can be used to provide continuous data collection and recording of patients in situations where alarms are not required. The device turns on automatically when the sensor is placed on the finger and turns off when the finger is removed. It may be used with Nonin's 8000AA-WO articulated finger clip sensor or the 8000J-WO flex sensor. The WristOx is also memory capable in conjunction with nVision® data management software (K033307). It is capable of storing up to 33 hours of SpO2 and pulse rate data.

    AI/ML Overview

    The provided text describes the Nonin Model 3100 WristOx® Pulse Oximeter, which was found substantially equivalent to a predicate device. However, the document does not contain explicit acceptance criteria or a detailed study report that proves the device meets specific performance criteria.

    The 510(k) summary (K052829) states that the device "has successfully undergone both bench and clinical testing in order to demonstrate that it has appropriate functional characteristics and is substantially equivalent to the predicate device." It also claims the device is "identical in everyway to the predicate device not with standing the changes specified in the labeling."

    Without a specific study outlining performance metrics, acceptance criteria, and detailed methodologies, the requested information cannot be fully extracted. The submission focuses on demonstrating substantial equivalence, implying that its performance is comparable to the predicate device (Model 3100 WristOx® (K030668)), which would have previously met its own established criteria.

    Therefore, for the current document, I can only report what is explicitly stated or implied about the testing, and cannot provide the detailed acceptance criteria and study particulars for the new device's performance.

    Here's an attempt to answer based on the provided text, with many fields indicating "Not explicitly stated":

    Acceptance Criteria and Device Performance

    Acceptance Criteria (Not explicitly stated for this device; assumed to be equivalent to predicate)Reported Device Performance
    Functional characteristics equivalent to predicate device (K030668)"successfully undergone both bench and clinical testing" to demonstrate appropriate functional characteristics and substantial equivalence.
    Principles of operation equivalent to predicate device (K030668)"substantially equivalent to the predicate device in terms of functional design and principles of operation."

    Detailed Study Information:

    1. Sample size used for the test set and the data provenance: Not explicitly stated. The document refers to "clinical testing" but does not provide details on sample size, participant demographics, or data provenance (e.g., country of origin, retrospective/prospective nature).

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. The document does not describe the establishment of a ground truth for a test set, nor does it mention any expert involvement for this purpose.

    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not explicitly stated. No adjudication method is mentioned in the provided text.

    4. 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: Not applicable. This device is a pulse oximeter, not an AI-assisted diagnostic tool for human readers. As such, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's function.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone measurement tool (a pulse oximeter). Clinical and bench testing would have evaluated its performance independently. No human-in-the-loop performance evaluation in the context of an "algorithm" is applicable here. The device measures, displays, and stores SpO2 and pulse rate.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. For a pulse oximeter, the ground truth for SpO2 measurement would typically involve a co-oximeter or blood gas analysis, but this is not detailed in the provided summary.

    7. The sample size for the training set: Not applicable and not explicitly stated. This device is not an AI/machine learning model that typically requires a "training set." Its functionality is based on electro-optical sensing principles.

    8. How the ground truth for the training set was established: Not applicable and not explicitly stated. See point 7.

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