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510(k) Data Aggregation

    K Number
    K962937
    Device Name
    CARDIO TEAM II
    Manufacturer
    VISION ELECTRONICS
    Date Cleared
    1997-04-10

    (255 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K963375
    Device Name
    CARDIACMONITOR
    Manufacturer
    VISION ELECTRONICS
    Date Cleared
    1997-02-28

    (185 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CardiacMonitor is a non-invasive, external ambulatory electrocardiographic (ECG) looping memory monitor. The device is activated by the patient who experiences transient symptoms and is intended for human use, in the home or workplace.

    Device Description

    The CardiacMonitor is a non-invasive, external ambulatory electrocardiographic (ECG) looping memory monitor. The device is activated by the patient who experiences transient symptoms and is intended for human use, in the home or workplace. The recorded ECG is sent by an acoustic signal from an internal speaker, using standard telephone lines to a telephonic receiver. The CardiacMonitor is the size of a Credit-card by about 0.31" thick.

    AI/ML Overview

    Given the provided text, the device in question (CardiacMonitor) is an electrocardiographic (ECG) looping memory monitor intended for patient-activated recording of transient cardiac symptoms. It's an older device, cleared in 1997. Due to its age and purpose, the "study" described is primarily a technical performance verification against established standards rather than a clinical trial involving human readers or extensive ground truth adjudication as seen in modern AI/ML device clearances.

    Here's the breakdown based on the provided text:

    Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    AAMI EC-13 Standards (Standard for Cardiac Monitors)"AAMI EC-13 ... test data results are all within the minimum and maximum allowable standards"
    AAMI EC-38 Standards (Standard for Ambulatory ECG Recorders)"AAMI EC-38 test data results are all within the minimum and maximum allowable standards"
    Equivalence to Predicate Device (HeartCard)"The CardiacMonitor Shares much of the same operating features as the predicate device, HeartCard and the technical specifications comparison reveal no substantial differences and no differences which would effect safety and effectiveness. The indications for use are the same."
    ECG data quality (P. vs P.P. mode)"The function of the (P.) or (P.P.) mode have no impact on the quality of the ECG data obtained."

    Study Details

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

      • Sample size: Not explicitly stated. The text mentions "test data results" for AAMI EC-13 and EC-38, implying that the device was subjected to a series of standardized tests. These standards typically define the number and type of tests, but not a "patient sample size" in the clinical trial sense.
      • Data provenance: Not explicitly stated beyond "AAMI EC-13 and EC-38 test data results." These are likely laboratory or bench tests following established protocols, not data from a specific country or retrospective/prospective patient cohort.

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

      • This is not applicable in the context of the provided information. The "ground truth" for compliance with AAMI standards would be the adherence to the technical specifications and expected electrical performance, verified by engineering and quality control procedures, rather than expert clinical interpretation of recordings.

    3. Adjudication method for the test set:

      • Not applicable. The "study" concerns technical compliance with standards, not a diagnostic accuracy study requiring adjudication of expert interpretations.

    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:

      • No. This device is from 1997 and is a simple event recorder. It does not employ AI, nor would a MRMC study be relevant for its clearance.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

      • Yes, in a sense. The "standalone" performance here refers to the device's technical ability to record and transmit ECG signals accurately according to AAMI standards. This is an "algorithm only" in the sense of the hardware and firmware functionality operating independently to meet technical specifications, not an AI algorithm.

    6. The type of ground truth used:

      • Technical Specifications and AAMI Standards Compliance: The ground truth is adherence to the electrical and mechanical performance parameters defined by AAMI EC-13 and EC-38 standards. This involves measuring various electrical characteristics (e.g., frequency response, noise levels, input impedance, gain accuracy) and mechanical durability, and verifying that they fall within the specified acceptable ranges.

    7. The sample size for the training set:

      • Not applicable. This device is not an AI/ML algorithm that requires a training set. Its functionality is based on traditional hardware and embedded firmware.

    8. How the ground truth for the training set was established:

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