(84 days)
The Bruno Élan Stairway Elevator System, Model SRE-3000, is a single user transport system, also commonly known as a stairway chairlift, or stairlift. It is a motorized device intended to assist transfers of a mobility impaired person up or down flights of stairs.
The Bruno Élan Stairway Elevator System, Model SRE-3000, is a single user transport system, also commonly known as a stairway chairlift, or stairlift. It is a motorized device intended to assist transfers of a mobility impaired person up or down flights of stairs.
My deepest apologies, but the document provided is a 510(k) clearance letter for a Bruno Élan Stairway Elevator System. This document type does not contain the detailed information necessary to answer the questions about acceptance criteria and study design for a device's performance, as it pertains to medical AI or diagnostic devices.
The letter simply states that the device (a stairlift) has been found substantially equivalent to a predicate device. It does not include:
- A table of acceptance criteria and reported device performance
- Sample sizes or data provenance for a test set
- Details about experts establishing ground truth
- Adjudication methods
- Multi-reader multi-case studies
- Standalone algorithm performance
- Type of ground truth used
- Training set sample size or how its ground truth was established
Therefore, I cannot fulfill your request based on the provided input.
§ 890.5150 Powered patient transport.
(a)
Powered patient stairway chair lifts —(1)Identification. A powered patient stairway chair lift is a motorized lift equipped with a seat and permanently mounted in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway.(2)
Classification. Class II. The stairway chair 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 American Society of Mechanical Engineers (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 chair in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing must demonstrate the ability of the device, including armrests, to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate restraints must be provided to prevent the user from falling from the device (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”);
(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; and
(v) Appropriate analysis and nonclinical testing must demonstrate the resistance of the device upholstery to ignition.
(b)
All other powered patient transport —(1)Identification. A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.(2)
Classification. Class II.