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510(k) Data Aggregation

    K Number
    K080373
    Device Name
    TACAHE PC1350 POWER WHEELCHAIR
    Manufacturer
    DALTON MEDICAL CORP.
    Date Cleared
    2008-04-14

    (62 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the Tacahe PC1350 is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

    Device Description

    Tacahe PC1350 Power Wheelchair

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the Dalton Medical Corp. Tacahe PC1350 Power Wheelchair. It focuses on regulatory approval and substantial equivalence to a predicate device, rather than detailed performance study results and acceptance criteria for a new AI or diagnostic device.

    Therefore, the document does not contain the information requested regarding:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set and data provenance.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method for the test set.
    5. MRMC comparative effectiveness study or AI improvement effect size.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    This is a regulatory document confirming clearance based on substantial equivalence, not a clinical or performance study report.

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