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510(k) Data Aggregation

    K Number
    K112187
    Device Name
    FM-1000 PLUS FETAL MONITOR
    Manufacturer
    ADVANCED INSTRUMENTATIONS, INC.
    Date Cleared
    2011-09-21

    (54 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K073221
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The FM-1000 Plus Fetal Monitor is used to monitor fetal well being during the antepartum period what is commonly called the non stress test. It is to be used by trained medical personnel in hospitals, clinics, physician's offices and in the patient's home by prescription or doctors orders.

    Device Description

    The FM-1000 Plus Fetal Monitor can provide different configurations according to different user requirements, FHRI (USI), FHR2 (US2), TOCO, FM (remote marker), AFM (automatic fetal movement mark), fetal stimulator (optional),DECG (direct fetal ECG, optional), and JUP(Intra-uterine Pressure, optional). The user can select the monitors according to requirements. FM-1000 Plus adopts 5.7" LCD, and the collected data, trends, and monitoring parameters are displayed at the same screen. A built-in thermal recorder is used to record the monitoring information.

    AI/ML Overview

    The provided text is a 510(k) Summary for the FM-1000 Plus Fetal Monitor. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific performance criteria through a clinical study. Therefore, the document explicitly states:

    "Clinical testing is not required"

    As a result, the following information, which would typically be found in a study proving a device meets acceptance criteria, is not available in this document:

    1. A table of acceptance criteria and the reported device performance
    2. Sample size used for the test set and the data provenance
    3. Number of experts used to establish the ground truth for the test set and their qualifications
    4. Adjudication method for the test set
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
    7. The type of ground truth used
    8. The sample size for the training set
    9. How the ground truth for the training set was established

    The submission relies on verification and validation testing to demonstrate performance and substantial equivalence to the predicate device, the Cadence II Fetal Monitor (K073221), rather than a clinical study with specific acceptance criteria as might be expected for an AI/CADe device.

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