(46 days)
The Explorer™ Powered Wheelchair provides enhanced mobility to physically challenged persons limited to a sitting position.
The Explorer™ Powered Wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The product has a metal frame with four wheels, an adjustable seat with armrests, and a controller attached to one armrest. The controller allows the rider to control the movement of the chair. The chair can be disassembled for transport and is provided with a battery charger.
The provided submission does not include acceptance criteria or a study proving the device meets acceptance criteria.
The document K023485 is a 510(k) premarket notification for the Explorer™ Powered Wheelchair. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical or comparative effectiveness studies.
Here's why the requested information is absent:
- "Performance testing: Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This statement explicitly indicates that the types of studies typically used to demonstrate performance against acceptance criteria were not included.
- Focus on Substantial Equivalence: The 510(k) summary and the FDA's decision letter both emphasize substantial equivalence to a predicate device (Regency Power Wheelchair, K001923) based on similar technological characteristics (e.g., tubular metal frames, battery operated, two motors, automatic braking systems, same controller, similar use parameters like travel range and maximum speed).
- Testing Conducted: While "Tests listed in the Guidance Document..." were conducted, these are typically engineering and safety tests, not performance studies designed to meet clinical acceptance criteria. The results of these tests are not detailed in the provided summary.
Therefore, I cannot populate the table or provide the requested details about acceptance criteria, study design, sample sizes, ground truth, or expert involvement, as this information is not present in the provided 510(k) submission.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).