(29 days)
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
| Acceptance Criteria (Standard Met) | Reported Device Performance |
|---|---|
| U.L. 1647 "Standard for Motor-Operated Massage and Exercise Machines" | Met |
| U.L. 73 "Standard for Motor Operated Appliances" | Met |
| California TB 117 (Flammability) for upholstery | Met |
| UFAC Fabric Classification (Class I) for upholstery | Met |
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.
§ 890.3110 Electric positioning chair.
(a)
Identification. An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. The device is used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions.(b)
Classification. Class II. The electric positioning chair is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption:(1) Appropriate analysis and non-clinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure;
(2) Appropriate analysis and non-clinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety;
(3) Appropriate analysis and non-clinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device;
(4) Appropriate analysis and non-clinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device;
(5) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ES60601-1, “Medical Electrical Equipment—Part 1: General Requirements for Basic Safety and Essential Performance,” and ANSI/AAMI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Electromagnetic Disturbances—Requirements and Tests”) must validate electromagnetic compatibility and electrical safety;
(6) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ISO 10993-1, “Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process,” ANSI/AAMI/ISO 10993-5, “Biological Evaluation of Medical Devices—Part 5: Tests for In Vitro Cytotoxicity,” and ANSI/AAMI/ISO 10993-10, “Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Skin Sensitization”) must validate that the skin-contacting components of the device are biocompatible;
(7) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of IEC 62304, “Medical Device Software—Software Life Cycle Processes”) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented;
(8) Appropriate analysis and non-clinical testing must validate that the device components are found to be non-flammable;
(9) Appropriate analysis and non-clinical testing must validate that the battery in the device (if applicable) performs as intended over the anticipated service life of the device; and
(10) Adequate patient labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device by the patient in the intended use environment.