(115 days)
To provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.
To provide mobility to persons limited to a seated position.
The Invacare Models Ranger II and Power 9000 front wheel drive power wheelchairs are battery powered, motor driven devices with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. They are non rigid, or "folding" type, front wheel drive power wheelchairs.
The wheelchairs are controlled using the Invacare Model MCC-MKIV RII Motor Controller and Joystick. They are powered by two Size 22NF 12 VDC batteries. Access to the batteries is gained from underneath the chairs will travel approximately 17 to 22 miles between charges, depending on use.
The wheelchairs consist of two basic sub-sections. These are the base section of the wheelchair, and the seating section of the wheelchair. Both are of welded steel construction. The base section includes the base frame, front drive wheels and axles, rear pivoting casters, motor/gearbox drive mechanism and batteries. The motor/gearbox location is adjustable, relative to the upper seating frame. This adjustment is used to compensate for weight and balance shift, which are both user dependent.
The seating, or upper section of the wheelchair, includes the seating upholstery, front foot rests, side arm rests, and joystick operating control. Seating sizes range from 14" wide to 20" wide, depending on user needs. The wheelchair motor controller is mounted to the side arm and under the backrest of the seat. The upholstery material is fabricated from either U240 Nylon, or reinforced vinyl, depending upon the user's preference. Both of these materials meet California 117 and Boston Fire Department BFD-1 specifications for fire retardancy.
This is a medical device application for a power wheelchair, K982064, which is a physical device and not an AI/ML algorithm. Therefore, the questions related to AI/ML specific performance, ground truth, and study designs are not applicable.
However, I can extract information regarding its performance testing.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ISO EMC Draft Standard 7176-14 (Titled "Draft ISO EMC Group Proposal: Electromagnetic Compatibility Addition" And Dated April 3, 1995) for powered wheelchairs and motorized scooters. | "In all instances, the Invacare Action Storm and Ranger II Front Wheel Drive Power Wheelchairs met the required performance criteria and functioned as intended." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the devices tested or the data provenance. It refers to a general test against a standard.
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)
Not applicable, as this is a physical medical device (power wheelchair) and not an AI/ML algorithm requiring expert-established ground truth. Performance was assessed against an engineering standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is a physical medical device subject to engineering standard testing, not human-read assessment.
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
Not applicable, as this is a physical medical device and not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device and not an AI/ML algorithm. The performance described is the standalone performance of the physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" or reference for performance was compliance with the ISO EMC Draft Standard 7176-14.
8. The sample size for the training set
Not applicable, as this is a physical medical device and not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as this is a physical medical device and not an AI/ML algorithm.
§ 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).