Search Results

The intended use of the Berkline Model Easy Lift Series Lift Out Chair to assist persons, who have difficulty rising from a seated position to a standing position.

The Berkline Model LC Series Lift Chairs are electrically powered, motor driven devices designed for use in the home or an extended care environment. Their intended function and use is to raise persons from a seated position to a standing position. They are designed for use by elderly or physically challenged individuals who have difficulty rising to a standing position once seated.

The chairs are consist primarily of welded steel frame, an upholstered chair assembly, and motorized lift actuator. A hand held pendant type control is used activate the drive motor and raise or lower the chair to the desired position. Model numbers and physical dimensions vary with the type of aesthetic style of the chair.

This document describes the 510(k) summary for the Berkline Model LC Series Lift Out Chairs, a device designed to assist individuals with difficulty rising from a seated position.

Here's an analysis of the provided information concerning acceptance criteria and study details:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided summary does not mention a traditional "test set" in the context of clinical or performance data for the device's intended use (i.e., assisting people to rise). Instead, the performance data refers to compliance with safety and materials standards. Therefore, information about sample size and data provenance for a test set regarding the clinical function is not available in this document.

The "testing" mentioned is related to engineering and material standards, not patient performance or outcomes.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable to the provided document. The device's performance is gauged against established industry standards (U.L., California TB, UFAC), rather than human expert-established ground truth for a clinical application.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a human expert-adjudicated test set in the context of the device's primary function.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported for this device, nor is it typically required for devices of this classification that meet established safety and engineering standards. The document does not discuss human reader performance or AI assistance.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study of an algorithm was not conducted or reported. This device is a mechanical lift chair, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" used for evaluating the Berkline Model LC Series Lift Out Chairs is compliance with established engineering, electrical safety, and material flammability standards. These standards themselves embody a consensus of safety and performance requirements.

8. Sample Size for the Training Set

This information is not applicable as the device is not an AI/ML algorithm or a system requiring a "training set" in the computational sense. The device is a manufactured mechanical product.

9. How Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated above (not an AI/ML device). The "ground truth" for the device's manufacturing and material selection would be established through adherence to engineering blueprints, material specifications, and quality control processes, all designed to meet the aforementioned industry standards.

Ask a specific question about this device