(33 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The Home Health Power Wheelchair, HC-200TR is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport, the seat can be tilted and reclined, and is provided with an onboard battery charger.
The provided text describes a 510(k) premarket notification for a power wheelchair, not an AI device. Therefore, a significant portion of the requested information (items 2-9) which are specific to AI/algorithm performance studies, cannot be extracted from this document.
However, I can extract information related to the acceptance criteria (performance testing) and a comparison summary which acts as a justification for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Testing Standards) | Reported Device Performance (Reference to compliance) |
|---|---|
| EMC Report ANSI / RESNA WC/Vol.2-1998 | Compliant (Implied by submission for substantial equivalence) |
| CISPR 11: 1990 | Compliant (Implied by submission for substantial equivalence) |
| EN61000-3-2: 1995 | Compliant (Implied by submission for substantial equivalence) |
| IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers - requirements and test methods) | Compliant (Implied by submission for substantial equivalence) |
| Resistance ignition test by SGS (for back upholstery material and similar casters/incline) | Passed |
| Braking time, distance, and dynamic stability for safety considerations (for max speed of 5 mph) | Met relevant requirements (Implied to ensure safety despite higher speed than predicate) |
Study that proves the device meets the acceptance criteria:
The document explicitly states "Performance Testing: EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers - requirements and test methods)". This indicates that a performance study was conducted to demonstrate compliance with these standards. Additionally, the material for the back upholstery was subject to a "resistance ignition test by SGS."
The bulk of the "study" for substantial equivalence for this device relies on a comparison summary to a legally marketed predicate device (SINON Power Wheelchair, SN-P401 (K040320)). This comparison highlights:
- Same intended use
- Same brand and similar U1 type batteries
- Same brand control systems (Dynamic SHARK for new, Dynamic DL for predicate)
- Same supplier for rechargers, which are UL certified
- Same removable armrest type
- Same casters size
- Same incline
- Back upholstery of the same material that passed a resistance ignition test by SGS.
- Cruising range: 25 miles (new device) vs. 20 miles (predicate). The difference is attributed to battery size, and it's stated that for real-life use, they are "substantially equivalent" as range depends on environmental factors.
- Maximum speed: 5 mph (new device) vs. 4 mph (predicate). It is claimed that the higher speed does not lead to any safety concerns and meets relevant requirements for braking time, distance, and dynamic stability, thus being "substantially equivalent" in this aspect.
- Minor differences: Appearance dimensions (overall, wheels, seat), seat can be tilted and reclined, and weight limit. These differences are deemed not to affect performance for the "regular operator" and are therefore "substantially equivalent."
Information not available in the provided text (as it pertains to AI/algorithm studies):
- Sample sizes used for the test set and the data provenance: Not applicable to this device type.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- 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).