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510(k) Data Aggregation

    K Number
    K113865
    Device Name
    PULTOL
    Manufacturer
    SHARP CORPORATION
    Date Cleared
    2012-03-21

    (82 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K081285,K001085,K053419
    Why did this record match?
    Reference Devices :

    K081285,K001085,K053419

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

    The Sharp Pulse Oximeter Model BM-500 and BM-510 is a non-invasive pulse oximeter indicated for use in the spot-check measurement and display of arterial blood oxygen saturation (SpO2) and pulse rate in hospitals or primary care settings.

    Device Description

    The Sharp Pulse Oximeter is a multi-parameter module comprising of a main unit (BM-500) and the SpO2 Sensor (BM-510) connected via the sensor cord. The device operates continuously to provide spot-check measurements of oxygen saturation and pulse when a patient's finger is inserted into the sensor and the ON button is depressed.

    AI/ML Overview

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Implicit)Reported Device Performance (Clinical Data)
    Statistical alignment with blood gas analyzer SpO2 results between 70-100% saturation."The pulse oximeters demonstrated statistical alignment with the blood gas analyzer SpO2 results."

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

    • Sample Size: 12 subjects
    • Data Provenance: The information provided does not specify the country of origin of the data, but the submitter is Sharp Corporation based in Japan.
    • Retrospective/Prospective: The study appears to be prospective, as hypoxia was "induced to different levels of oxyhemoglobin saturation" in subjects for the purpose of the study.

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

    • Number of Experts: Not applicable. The ground truth was established by a blood gas analyzer, not human experts.
    • Qualifications of Experts: N/A

    4. Adjudication Method for the Test Set:

    • Adjudication Method: Not applicable. The ground truth was established by objective medical equipment (blood gas analyzer).

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

    • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The study involved comparing the device against a blood gas analyzer, not against human readers with and without AI assistance.

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

    • Yes, a standalone performance study was done. The device's SpO2 accuracy and pulse rate accuracy were assessed by comparing its readings directly with a blood gas analyzer.

    7. The Type of Ground Truth Used:

    • Ground Truth: Objective medical equipment (blood gas analyzer). This serves as a direct, gold-standard measurement of arterial blood oxygen saturation.

    8. The Sample Size for the Training Set:

    • The document does not explicitly mention a separate "training set" or its size. The clinical data description focuses on the evaluation of the device's accuracy with 12 subjects. While device development involves internal testing, the provided summary focuses on the clinical validation data.

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

    • Since a distinct "training set" is not detailed in the provided information, the method for establishing its ground truth is not described. The clinical validation ground truth was established by a blood gas analyzer.
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