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510(k) Data Aggregation

    K Number
    K971015
    Device Name
    AHCS HEMOPERFUSION SYSTEM
    Manufacturer
    AMERICAN HEALTH CARE SYSTEMS, INC.
    Date Cleared
    1997-10-22

    (216 days)

    Product Code
    FLD
    Regulation Number
    876.5870
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AHCS HEMOPERFUSION SYSTEM

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

    Blood detoxification and drug removal/retention

    Device Description

    AHCS Hemoperfusion System

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (AHCS Hemoperfusion System with heparin/hydrogel coated charcoal). This document focuses on regulatory approval and substantial equivalence to a predicate device.

    It does not contain information on the acceptance criteria, study details, or performance metrics of the device itself. The letter confirms the device can be marketed based on its substantial equivalence to previously approved devices, subject to general controls and good manufacturing practices.

    Therefore, I cannot extract the requested information like:

    1. A table of acceptance criteria and the reported device performance: This document doesn't provide performance data or specific acceptance criteria for a validation study.
    2. Sample sized used for the test set and the data provenance: Not available in this regulatory letter.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided.
    4. Adjudication method: Not applicable or provided.
    5. Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned.
    6. Standalone performance study: Not mentioned.
    7. Type of ground truth used: Not applicable or provided for this type of regulatory submission.
    8. Sample size for the training set: Not applicable or provided.
    9. How the ground truth for the training set was established: Not applicable or provided.
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