(131 days)
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.
§ 890.3930 Wheelchair elevator.
(a)
Permanently mounted wheelchair platform lift —(1)Identification. A permanently mounted wheelchair platform lift is a motorized vertical or inclined platform lift device permanently installed in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a guided platform to move a person from one level to another, with or without a wheelchair.(2)
Classification. Class II. The permanently mounted wheelchair platform lift 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:(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the platform in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the device to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the enclosures to prevent the user from falling from the device; and
(iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety.
(b)
Portable wheelchair elevators —(1)Identification. A portable wheelchair elevator is a motorized lift device that is not permanently mounted in one location and that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a means to move a person, with or without a wheelchair, from one level to another (e.g., portable platform lifts, attendant-operated stair climbing devices for wheelchairs).(2)
Classification. Class II.