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510(k) Data Aggregation

    K Number
    K970700
    Device Name
    FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
    Manufacturer
    FRESENIUS USA, INC.
    Date Cleared
    1998-09-15

    (567 days)

    Product Code
    MSE
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX

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

    Hemoflow dialyzers are designed for use in acute or chronic hemodialysis therapies as either single use or multiple use.

    Device Description

    Fresenius Polysulfone Hemodialyzers

    AI/ML Overview

    The provided documents are a letter from the FDA regarding a 510(k) premarket notification and an "Indications for Use" statement for Fresenius Polysulfone Hemodialyzers. These documents are from 1998 and pertain to medical devices (dialyzers), not an AI-powered diagnostic device.

    Therefore, the information required to describe the acceptance criteria and the study proving an AI device meets those criteria (such as detailed performance metrics, sample sizes, expert qualifications, ground truth methods, or MRMC studies) is not present in the provided text.

    The documents confirm that the specified Fresenius Hemoflow Dialyzers were found "substantially equivalent" to predicate devices for use in acute or chronic hemodialysis. This substantial equivalence determination by the FDA is the "acceptance criteria" in this context, rather than specific performance metrics detailed in a study report for an AI device.

    To answer your specific questions:

    1. A table of acceptance criteria and the reported device performance: Not applicable/not provided. The acceptance was based on substantial equivalence to predicate devices, not on specific performance metrics of an AI model against predefined acceptance criteria.
    2. Sample size used for the test set and the data provenance: Not applicable/not provided. This is a medical device approval based on substantial equivalence, not an AI model validation study.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. Ground truth for an AI model is not relevant here.
    4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not provided.
    5. 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: Not applicable/not provided. This is not an AI device.
    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/not provided. This is not an AI device.
    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not provided.
    8. The sample size for the training set: Not applicable/not provided.
    9. How the ground truth for the training set was established: Not applicable/not provided.
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