(7 days)
The intended use of the Stealth Products Powered Seating System is to provide pressure relief to persons confined to a wheelchair, by providing a method of tilting and reclining the wheelchair seat and back.
The intended function and use of the Stealth Products Powered Seating System for Power Wheelchairs is to provide pressure relief to power wheelchair users, by providing a means of tilting and reclining the seat and back.
The Stealth Products Powered Seating System for power wheelchairs is a battery powered, motorized seating system, designed for use with power wheelchairs. It's intended function and use is to provide pressure relief to power wheelchair users, by providing a means of tilting and reclining the seat and back.
The system consists primarily of a main frame assembly, a system mounting plate, linear actuators and a toggle switch assembly. The main frame assembly supports the patient during use of the seating system. The system mounting plate is the interface between the Stealth Seating System and the wheelchair. The linear actuator provides the motion needed to position the system, and the toggle switch assembly is the means by which the tilt/recline functions are activated.
The Stealth Powered Seating System is designed to adapt to wheelchairs with round, square, or rectangular frames. Minimum frame requirements are 1 ½" diameter x .09 wall for round frames and a 1" mounting surface x .09 wall for square and rectangular frames.
The provided text describes a 510(k) Premarket Notification for the "Stealth Products Powered Seating System for Power Wheelchairs." While it states that performance and functional testing were conducted, the document does not provide specific acceptance criteria or detailed study results demonstrating how the device meets those criteria.
It only states: "In all cases, the Stealth System passed its' performance requirements and met specifications."
Therefore, I cannot populate the requested table and details because the information is not present in the provided text.
Here's a breakdown of the specific information that is missing from the document:
- A table of acceptance criteria and the reported device performance: This is not present. The document generally states the system "passed its' performance requirements and met specifications" but does not enumerate these requirements or specific performance metrics.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study with a "ground truth" seems to have been conducted or reported. The tests conducted were "performance and functional testing," implying engineering or bench testing.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable. This device is a powered seating system, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as detailed above.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
§ 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).