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The Bella Elevator, LLC vertical Platform lift models RL, UL, SL, EL, EPL are designed 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 Bella Elevator, LLC vertical platform lift models RL, UL, SL, EPL are designed 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 model EL and EPL are located within with their own integrated enclosure. The model SL is located within a hoistway. The UL model is unenclosed, other than guarding around the platform area. The RL model is unenclosed and intended for applications found in a residence. These models are designed for both indoor and outdoor applications. Each referenced model has a capacity of 750 lbs to accommodate a person in a wheelchair and an attendant. The lifts are available with a chain hydraulic drive system or an acme screw drive system. Backup systems are available for emergency operation and evacuation. All controls are low voltage, constant pressure. Use may be restricted to authorized persons with key switch located on control panels.

The provided text is a 510(k) summary for a medical device (Vertical Platform Lifts) and related FDA correspondence. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically associated with AI/software medical device submissions (e.g., performance metrics like sensitivity, specificity, AUC).

The documentation focuses on the device description, intended use, and its compliance with established national safety standards for physical devices. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving their fulfillment as per your prompt's structure, which is designed for AI/software-based devices.

The "Performance Data" section in the document states: "The Bella Elevator, LLC Vertical Platform Lift models RL, UL, SL, EL, and ELP fully comply with the applicable sections of the following National Safety Standards:

• ASME A18.1- Safety Standard for Platform Lifts and Stairway Chairlifts
• ASME 17.5- Electrical Code for Elevating Devices"

This indicates that the "acceptance criteria" for this physical device are the requirements of these safety standards, and the "study" proving compliance is likely a series of engineering tests and demonstrations showing the device adheres to these standards. However, the document does not elaborate on specific metrics, sample sizes, ground truth, or expert involvement as requested for AI/software evaluation.

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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.

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.

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:

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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