(80 days)
The intended use of the IMC- Heartway Model HPS Wheelchair is to provide mobility to adults with the ability to place themselves or be placed in a sitting position and have the capacity to operate a simple hand control.
Not Found
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific criteria for the IMC-Heartway Model HPS Electric Powered Wheelchair.
The document is a 510(k) substantial equivalence determination letter from the FDA. It states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities. However, it does not detail:
- Acceptance criteria
- Reported device performance
- Sample sizes
- Data provenance
- Number or qualifications of experts
- Adjudication method
- MRMC comparative effectiveness studies
- Standalone algorithm performance
- Type of ground truth used
- Training set sample size
- Ground truth establishment for training set
The "Indications for Use Statement" simply describes the intended user and purpose of the wheelchair, not performance metrics or study results.
§ 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).