(68 days)
The STAIR-LIFT is intended to mechanically transport one person in a wheelchair or in a fold-down seat up and down stairs in a private or public facility either indoors or outdoors.
The STAIR-LIFT is an unenclosed inclined platform lift designed to carry a wheelchair and its occupant or a mobility-impaired person seated on a folding seat between floors in a public or private facility. There are currently three different models designed to address the nature of the stairway involved in its use. The GSL-1 model is designed for straight and turning stairways. It follows the inside radius of a stairwell. The GSL-2 model is designed strictly for straight stairways, and the GSL-3 model is designed for complex turning stairways that follow either the inside or outside radius of the stairwell. Each of the three models is accessible via one of three types of platform/ramp units. These platform/ramps are raised either manually or electrically. The GSL-1 and GSL-3 (turning) models use two parallel steel tubes, custom built for the stairway, to support their platforms. The tubes contain a continuous loop of wire haul rope that attaches to the platform through a slot in the upper tube. An electrical motor at the top of the system turns a drive cog, which moves the wire haul rope, carrying the wheelchair platform up and down the stairway. Delrin spheres and knuckles are affixed to the rope to keep it in the center of the tubes. The GSL-2 (straight) model uses three square structural steel rails to support the platform. The top two rails contain a roller chain which is held in a continuous loop by aircraft cable. The chains are attached to the platform through a slot in the upper rail. The bottom rail guides the platform, while an electrical drive motor at the top of the system propels the chains.
This K981486 document is a K510(k) premarket notification for a medical device called the STAIR-LIFT. It details the device's description, intended use, and a comparison to a predicate device (SAVARIA ES-125). However, this document does not contain any information about acceptance criteria for performance, a study proving it meets those criteria, or any details related to sample sizes, ground truth, or expert involvement as typically found in clinical validation studies for AI/ML devices.
The K510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through new clinical studies, especially for devices without AI/ML components.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving device performance based on the provided text. The document is about a physical stair lift device, not a diagnostic or AI/ML-driven device that would typically involve such performance metrics and studies.
§ 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.