(51 days)
The product will be used by the patient to assist in navigating a specific set of stairs. This is a self-contained product that is mounted to the tread of a staircase. A trained dealer will install the unit, test it and teach the end user how to operate it. The typical user is someone who has limited function of their knees, hips or ankles and/or has trouble bending these joints. Other users include rehabilitated stroke victims, those inflicted with MS, arthritis, heart disease, and those who cannot handle the exertion of walking up and down the stairs. The unit may be recommended by doctors or physical therapists, for those who are recuperating but a large number of users acquire a stairway elevator just because to eases the burden of climbing stairs, improving their quality of life. For those who are wheelchair bound, it requires that they be able to transfer and is usually an option only if the physical limitations of the residence prohibits a vertical elevator.
The Stepsaver is a stairway chairlift designed to carry a rated load of 300 lb. directly up and down a set of stairs in a residence. The Step-saver is designed to travel a maximum 32 feet at a rated speed of 18 feet per minute. Safety switches installed on the Step-saver stop the carriage when it reaches the top or bottom of the stairway. The footrest incorporates obstruction sensors, which will stop the carriage if an obstacle is encountered on the stairs. Features include: Rack and pinion drive 60 and 90 degree swivel at top Adjustable seat height Seat belt with positive locking mechanism Flip-up padded armrests Constant pressure control switch on armrest (reversible side) Obstacle sensor Swivel seat actuator Electronic controller with soft start
This document is a 510(k) summary for the "Step-saver (B2002)" Stairway Chairlift. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
Based on the provided text, the device is not an AI/ML powered medical device, but rather a physical stairway chairlift. Therefore, the questions regarding acceptance criteria, study details, and AI/ML specific metrics (like MRMC studies, standalone performance, training sets, etc.) are not applicable in the context of typical AI/ML device submissions.
The submission focuses on demonstrating substantial equivalence to a predicate device (Bruno Electra-Ride K921648) by meeting established safety standards for such equipment.
Here's an attempt to extract relevant information, acknowledging that many fields will be N/A due to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Standards Compliance (Substantial Equivalence) | Both the Step-saver and the predicate device (Bruno Electra-Ride) "have been designed and engineered to meet and exceed the safety standards CSA-B355 - 'Lifts for persons with physical disabilities' and ASME A17.1 part XX and part XXI 'Safety Code for Elevators and Escalators'." |
| Rated Load Capacity | 300 lb. (Step-saver) |
| Maximum Travel Distance | 32 feet (Step-saver) |
| Rated Speed | 18 feet per minute (Step-saver) |
| Safety Features | Safety switches (top/bottom stops), obstruction sensors on footrest (stops carriage), rack and pinion drive, 60/90 degree swivel at top, adjustable seat height, seat belt with positive locking mechanism, flip-up padded armrests, constant pressure control switch on armrest, swivel seat actuator, electronic controller with soft start. (Step-saver) |
| Intended Use Equivalence | Both products "are used by the patient to assist in navigating a specific set of stairs. They are both self-contained product that are mounted to the tread of a staircase." (Step-saver and Bruno Electra-Ride) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This is a physical device submission demonstrating compliance with engineering standards, not a data-driven AI/ML model for which a test set of data would be used. The "study" here refers to the engineering and design process to meet established safety standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. Ground truth in the context of an AI/ML model is not applicable here. Compliance with safety standards would be assessed by engineering experts, testing bodies, and regulatory agencies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are specific to human review of data, typically for AI/ML or clinical trial endpoints.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. This device does not involve human readers interpreting medical images or data. It is a mechanical assistant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device is a mechanical system, not an algorithm. Its "standalone" performance would be its functional operation in isolation, which is implicitly covered by its design specifications and compliance with safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's safety and effectiveness lies in its compliance with established engineering and safety standards (CSA-B355 and ASME A17.1 parts XX and XXI), as well as its functional specifications (load capacity, speed, safety features).
8. The sample size for the training set
- N/A. There is no "training set" in the context of an AI/ML model. The design and engineering process for this mechanical device would involve iterative design, prototyping, and testing.
9. How the ground truth for the training set was established
- N/A. There is no "training set" or "ground truth for training" as understood in AI/ML development. The "ground truth" for its design and manufacturing is adherence to engineering principles, materials science, and established safety regulations for medical/accessibility devices.
§ 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.