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510(k) Data Aggregation

    K Number
    K112135
    Date Cleared
    2011-08-05

    (10 days)

    Product Code
    Regulation Number
    870.2340
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the ECG-6 Series Electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface with ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is only intended to be used on adult patients and is offered to clinicians on an advisory basis only.

    Device Description

    ECG-6 series Smart ECG includes three models ECG-6 Pro, ECG-6 Plus and ECG-6. Device features include as follows: Portable, lightweight design. Easy data input and operation. Alphanumeric keyboard and one-touch operation. Built-in rechargeable battery, AC/DC power supply. Automatic analysis and diagnostic software (SEMIP) for adults. Heart rate variability (HRV) analysis. Internal thermal printer and external printer. Support external archiving: USB flash disk, card reader. Data transmission to PC via Ethernet or serial port.

    AI/ML Overview

    This submission describes the ECG-6 Series Electrocardiograph, which includes models ECG-6 Pro, ECG-6 Plus, and ECG-6. The device is intended to acquire ECG signals from adult and pediatric patients and provides automatic analysis and diagnostic software (SEMIP) for adults.

    Here's an analysis of the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document does not explicitly define acceptance criteria for specific performance metrics (e.g., sensitivity, specificity, accuracy) for the diagnostic software. Instead, it states that "Software testing," "Risk analysis," "Safety testing," and "Performance test" were conducted.

    The "Predicate Device" section indicates comparisons were made to the SE-601 Series Electrocardiograph (K090367) by EDAN Instruments, implying that the new device aims for similar performance. However, no specific performance values are reported for either the predicate or the new device in terms of diagnostic accuracy.

    Table: Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Stated or Implied)Reported Device Performance
    Software testing completedConducted
    Risk analysis completedConducted
    Safety testing completedConducted
    Performance test completedConducted
    Substantial equivalence to predicate device (SE-601 Series Electrocardiograph K090367) based on similar technology and intended useClaimed and granted (K112135)
    Compliance with general controls and relevant regulations (e.g., GMP, labeling)Implied by 510(k) clearance

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

    The document does not provide information on the sample size used for any test set related to the automatic analysis and diagnostic software. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of data) for any testing that might have been performed to validate the diagnostic software.

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

    The document does not mention the use of experts or how ground truth was established for any test set related to the diagnostic software.

    4. Adjudication Method for the Test Set:

    No information is provided regarding any adjudication method for a test set, as details about a test set and ground truth establishment are absent.

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

    The document does not describe an MRMC comparative effectiveness study. There is no mention of human readers improving with or without AI assistance, nor any effect size. The interpreted ECG is offered to clinicians "on an advisory basis only," suggesting it's an aid, but no formal study comparing human performance with and without this aid is described.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

    The document states that the device includes "Automatic analysis and diagnostic software (SEMIP) for adults." This implies a standalone algorithm for interpretation. However, no specific standalone performance metrics (e.g., sensitivity, specificity, accuracy for disease detection) are reported for this algorithm. The statement "Clinical testing is not required" further indicates that rigorous clinical validation of the diagnostic performance was not part of this 510(k) submission. The FDA letter confirms the 510(k) was based on substantial equivalence, not necessarily extensive clinical performance testing.

    7. The Type of Ground Truth Used:

    Since no performance metrics are reported for the diagnostic software, and no specific test set is described, the type of ground truth used is not specified and appears not to have been a requirement for this specific 510(k) clearance. The clearance is based on substantial equivalence to a predicate device, implying that the predicate's established performance (which is also not detailed here) was sufficient.

    8. The Sample Size for the Training Set:

    The document does not provide any information regarding the sample size of the training set for the SEMIP diagnostic software.

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

    The document does not provide any information regarding how the ground truth for the training set was established for the SEMIP diagnostic software.

    Summary of Device Performance Study:

    Based on the provided text, the 510(k) submission for the ECG-6 Series Electrocardiograph primarily relies on a demonstration of substantial equivalence to a predicate device (SE-601 Series Electrocardiograph K090367 by EDAN Instruments).

    • No specific clinical study demonstrating the performance of the diagnostic software (SEMIP) in terms of accuracy, sensitivity, or specificity is presented. The document explicitly states "Clinical testing is not required."
    • The "effectiveness" of the device, particularly the diagnostic software, is implicitly assumed through its similarity to the predicate device and the conduct of non-clinical tests (software, risk, safety, and performance).
    • The 510(k) focuses on the device's ability to "acquire ECG signals" and that the "interpreted ECG with measurements and interpretive statements is only intended to be used on adult patients and is offered to clinicians on an advisory basis only," rather than proving definitive diagnostic performance of the automated interpretation.
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