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510(k) Data Aggregation

    K Number
    K091881
    Device Name
    RPL/CPL VERTICAL PLATFORM LIFTS
    Manufacturer
    HARMAR SUMMIT LLC
    Date Cleared
    2009-07-01

    (7 days)

    Product Code
    ING
    Regulation Number
    890.3930
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K061514
    Why did this record match?
    Device Name :

    RPL/CPL VERTICAL PLATFORM LIFTS

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

    The intended use of the Harmar Summit RPL/CPL Vertical Platform Lifts is to transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility.

    Device Description

    The Harmar Summit, LLC Models RPL and CPL Vertical Platform Lifts are AC powered, patient transport devices designed for use in both residential and commercial applications. Their intended function and use is to transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility.

    The RPL lift is designed for residential applications and will support a maximum load of 600 lbs. The CPL lift is designed for commercial or public applications, and will support a maximum load of 750 lbs.

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification for the Harmar Summit RPL/CPL Vertical Platform Lifts. This document focuses on demonstrating substantial equivalence to a predicate device and adherence to industry standards, rather than presenting a clinical study with detailed acceptance criteria and performance data for a new medical device.

    Therefore, many of the requested elements for describing an acceptance criteria study (e.g., sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission. The device in question is a wheelchair elevator, which is more of a mechanical and electrical safety device than a diagnostic or therapeutic medical device requiring extensive clinical trials with human subjects for efficacy.

    However, I can extract the information that is available:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Standards Conformance)Reported Device Performance
    ASME A18.1, Section 2 Vertical Platform LiftsThe RPL lift is designed to conform with this standard.
    CSA B44.1 / ASME 17.5 Elevator and Escalator Electrical EquipmentThe RPL lift is designed to conform with this standard.
    ASME A18.1, Section 5 -- Private Residence Vertical Platform LiftsThe RPL lift is designed to conform with this standard.
    Maximum Load (RPL - Residential)600 lbs
    Maximum Load (CPL - Commercial/Public)750 lbs
    Intended UseTransport persons with a mobility disability (wheelchair or ambulatory) up and down between levels of a residential or public facility.

    Regarding the other points, based on the provided text, the following apply:

    • 2. Sample size used for the test set and the data provenance: Not applicable. This submission relies on conformance to engineering standards, not on a clinical test set from human subjects.
    • 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for this type of device is defined by the technical specifications and safety standards.
    • 4. Adjudication method for the test set: Not applicable.
    • 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. This is not an AI-enabled diagnostic or analytical device.
    • 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical transport device.
    • 7. The type of ground truth used: Conformance to established engineering and safety standards (ASME A18.1, CSA B44.1 / ASME 17.5) and the stated load capacities for the RPL and CPL models.
    • 8. The sample size for the training set: Not applicable. There is no "training set" in the context of machine learning for this device. The design and validation are based on engineering principles and standard compliance.
    • 9. How the ground truth for the training set was established: Not applicable.
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