(18 days)
Sunrise Medical powered wheelchairs empower physically challenged persons by providing a means of mobility. This includes conditions in all ages such as: Arthritis, Amputee, Paraplegic, Cerebral Palsy, Hemiplegic, Tetraplegic (Quadraplegic), Spina Bifida, Head Injury or Trauma, Muscular Dystrophy, Multiple Sclerosis, Polio, Geriatric Conditions, And other immobilizing or debilitating conditions. A wheel chair with Bus Transport option may be used for motor vehicle transportation, with the use of wheelchair tie down and occupant restraint system (WTORS) that meet the requirements of SAE J 2249.
The G-424 is a mid-wheel drive, moderate duty chair that comes in one basic configuration. It is available with the Pilot controller. The Quickie G-424 Power Wheelchair consists of the same basic components found on the P200, such as a frame with suspension, seat, armrests, footrest, cushion, casters and drive wheels. Accessories include items such as positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc. As motorized wheelchairs, they also contain controllers, joysticks, motors, brakes, drive wheels and batteries. Key changes between the P200 and the G-424 are the replacement of anti-tip wheels with anti-tip casters, change from aluminum to steel frame construction, revised suspension, revised modular seat and use of the Pilot controller from Penny & Giles. Aesthetics have been improved by adding a plastic thermoformed molded cover.
Here's an analysis of the provided text regarding the acceptance criteria and study for the G-424 Power Wheelchair:
Description of Device: The G-424 is a mid-wheel drive, moderate-duty power wheelchair. Key changes from its predicate device (Quickie P200) include:
- Replacement of anti-tip wheels with anti-tip casters.
- Change from aluminum to steel frame construction.
- Revised suspension.
- Revised modular seat.
- Use of the Pilot controller from Penny & Giles.
- Improved aesthetics with a plastic thermoformed molded cover.
Intended Use: To provide mobility for physically challenged persons of all ages, including those with conditions such as Arthritis, Amputee, Paraplegic, Cerebral Palsy, Hemiplegic, Tetraplegic (Quadraplegic), Spina Bifida, Head Injury or Trauma, Muscular Dystrophy, Multiple Sclerosis, Polio, Geriatric conditions, and other immobilizing or debilitating conditions.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Reported Device Performance |
|---|---|
| Static Stability | Pass |
| Dynamic Stability | Pass |
| Effectiveness of Brakes | Pass |
| Energy Consumption | Pass |
| Overall Dimensions | Pass |
| Maximum Speed, Acceleration, and Retardation | Pass |
| Static Impact | Pass |
| Fatigue Strength | Pass |
| Climatic Test | Pass |
| Obstacle Climbing Ability | Pass |
| Testing of Power and Control System | Pass |
| EMC Testing | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of wheelchairs or test units) used for the testing. It also does not specify the country of origin of the data or whether the tests were retrospective or prospective. The testing was conducted to "ISO7176 and ANSI/RESNA Wheelchair Standards," which are international and American standards, respectively.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This document describes performance testing of a physical medical device (power wheelchair) against established engineering and safety standards (ISO7176 and ANSI/RESNA). The "ground truth" here is objective measurement and observation of the device's adherence to these standards. Therefore, "experts" in the context of establishing ground truth for image interpretation or clinical outcomes (like radiologists) are not applicable. The implicit experts would be the qualified engineers and technicians performing the standard tests and interpreting the results according to the specified criteria. The number and specific qualifications of these individuals are not provided.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are typically used for clinical studies involving subjective assessments (e.g., image interpretation by multiple readers). This document pertains to objective engineering and performance testing against predefined standards. There is no mention of an adjudication method in this context, as the results are likely determined by quantitative measurements and pass/fail criteria from the standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study assesses human reader performance, often with and without AI assistance, which is not relevant for the performance testing of a physical device like a power wheelchair.
6. Standalone (Algorithm Only) Performance Study
No standalone (algorithm only) performance study was done. This concept is applicable to software algorithms, particularly in AI/ML, not for the physical performance of a power wheelchair. The "performance" discussed here refers to the device's physical capabilities and safety features.
7. Type of Ground Truth Used
The ground truth used for this study is based on objective measurements and pass/fail criteria defined within the ISO7176 and ANSI/RESNA Wheelchair Standards. These standards would specify the methodologies, parameters, and acceptable ranges for each test (e.g., maximum allowable dynamic tilt, braking distance, fatigue cycles).
8. Sample Size for the Training Set
This document describes the testing of a physical medical device. There is no "training set" in the context of machine learning algorithms. The tests performed are to validate the final product's conformance to established engineering standards. Engineering design and development (which could involve iterative testing and refinement, analogous in some ways to training) would precede this final validation testing, but a distinct "training set" as understood in AI/ML is not applicable.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" is not applicable here. The device's design and manufacturing processes are validated against engineering specifications, which themselves are derived from safety and performance standards. The "ground truth" for the device's performance is ultimately defined by its ability to meet these established engineering and regulatory standards.
§ 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).