(290 days)
The specific intended use of the power wheelchair, which is the subject device, is identical to pre-existing or predicate devices. I.H.S. CHIPS POWER CHAIR helps promote mobility, both indoors, for the intended user commonly lacking full use of lower extremities. This limited use could be of short or long duration and caused by numerous medical conditions, ranging from spinal cord injuries to temporary broken bones in a lower extremity.
Powered Wheelchair. Our subject device provides mobility by incorporating a joy stick type controller which sends power to electric gear motors, which in turn are directly driving two rear wheels which propel the device. The controller on the subject device, similar to predicate devices, incorporates safety features such as, speed control, sensitivity control, battery life indicator and power on and off indicator light. The main product components include a steel tubular welded frame which supports a sitting surface. Both the seat and the back support are made of a durable nylon material. In addition, the frame incorporates adjustable and removable armrests, providing support for the user, and is removable to facilitate transfer into and out of the wheelchair. Both leg rests and foot rests are designed to be fully adjustable to accommodate a variety of anatomical differences. All leg rests and foot rests assembly are designed to swing away to facilitate entry and exit to the power chair and are removable to facilitate transportation of the device. Power is supplied to the device by incorporating two 12 volt wet or gel cell batteries providing a 24 volt system. This in turn supplies power to two rear mounted direct drive motors, both incorporating electromechanical automatic brakes. The motors in turn provide power to a sealed gear box which transfers power to the rear wheels. The fully programmable control system provides reliable, precise control and conforms to the latest International Standards. It has plenty of drive to cope with curbs or hill climbing by continually monitoring motor voltage and current. It readily maintains constant speed over demanding uneven terrain and prevents unwanted rolling on slopes. It handles currents from 20 Amps per channel, is fully programmable, incorporates true charge battery level indicator, has user speed and response controls, and a horn to alert others. It incorporates sophisticated diagnostics to facilitate repair and provides speed stability on slopes for safety. It incorporates hand tremor dampening for users who have poor motor control.
The provided document is a 510(k) summary for a powered wheelchair, the "CHIPS Powered Wheelchair," submitted by I.H.S. International Healthcare Solutions, Inc. in 1995. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance metrics for the device itself. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, or MRMC studies for AI devices.
The document primarily describes the device's features and intended use, comparing them to existing powered wheelchairs (predicate devices) to claim substantial equivalence for regulatory approval.
Here's a breakdown of why this document doesn't provide the requested information:
- Type of Device: The device is a "Powered Wheelchair," a physical medical device. The requested information format (acceptance criteria, test sets, ground truth, MRMC studies) is typically associated with the evaluation of AI/ML-driven software as a medical device (SaMD) or AI-enabled medical devices.
- Regulatory Pathway: The 510(k) pathway for medical devices focuses on demonstrating substantial equivalence to a legally marketed predicate device, often through performance testing, comparison of technological characteristics, and intended use. It is not designed to evaluate novel AI algorithms.
- Content of the Document: The document details the physical components (frame, seat, armrests, leg rests), power system (batteries, motors), control system (joystick, speed control, safety features), and mentions compliance with International Standards (ISO 9001, ISO 7176/14, TUV, Swedish Handicap Institute Approval) as evidence of safety and effectiveness, similar to predicate devices. It references "Technical Specifications and Test Reports" in Sections 4 and 5, but these reports are not included in the provided text.
In summary, none of the requested information regarding acceptance criteria and a study proving their fulfillment for an AI/ML device is present in the provided 510(k) summary for a powered wheelchair.
§ 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).