(209 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. It is designed for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and packed dirt) that are free of large obstacles and inclines greater than 8 degrees.
A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or impossible due to illness, injury, or disability.
The Manual Wheelchairs Model SY 100-MA02 (02A & 02B) and Model SY 100-MA06 (or other clients private labeling) are user propelled, manually operated folding wheelchairs that are indicated for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and packed dirt) that are free of large obstacles and inclines greater than 8 degrees. Each consists of four wheels, a mechanical steel frame and nylon upholstery that is ignition resistant. The device is designed to be lightweight and foldable, and can be dissembled. In both models, both rear and caster wheels use solid tires.
The model SY100-MA02 has two sub-models (02A & 02B) which both has a physical dimension of 1025 (depth) x 661 (width) x 920 (height) mm, with the seat itself has a dimension of 408 (depth) x 440 (width) x 455 (height) mm. The device has a weight capacity of 130 kilograms.
Sub-model MA02A uses hard plastic back wheels and weighs approximately 16.5 kilograms. Sub-model MA02B uses wired steel wheels and weighs 13.8 kilograms. Both sub-models are dark green in color.
Model SY100-MA06 has a physical dimension of 1026 (depth) x 651 (width) x 860 (height) mm. with the seat itself has a dimension of 394 (depth) x 374 (width) x 482 (height) mm, and a weight capacity of 100 kilograms, and weighs approximately 15.2 kilograms.
The provided text describes a 510(k) premarket notification for a manual wheelchair and does not contain information about an AI/ML powered device. Therefore, many of the requested categories in the prompt are not applicable.
However, I can extract information related to the acceptance criteria and the study performed for this manual wheelchair.
1. Table of Acceptance Criteria and Reported Device Performance
| Description | Acceptance Criteria (Test Standard) | Reported Device Performance |
|---|---|---|
| Static Stability | Meets ISO 7176-1:1999 | Meets ISO 7176-1:1999 |
| Effectiveness of Brakes | Meets ISO 7176-3: 2003 | Meets ISO 7176-3: 2003 |
| Static Strength | Meets ISO 7176-8: 1998 | Meets ISO 7176-8: 1998 |
| Impact Strength | Meets ISO 7176-8: 1998 | Meets ISO 7176-8: 1998 |
| Fatigue Strength | Meets ISO 7176-8:1998 | Meets ISO 7176-8:1998 |
| Resistance to Ignition | Meets ISO 7176-16:1997 | Meets ISO 7176-16:1997 |
| Weight Capacity (Model SY100-MA02) | 130 Kg | 130 Kg |
| Weight Capacity (Model SY100-MA06) | 100 Kg | 100 Kg |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "Our Devices" (Manual Wheelchair Model SY100-MA02 (02A & 02B) and Model SY100-MA06) as having undergone testing. It's implied that at least one of each model/sub-model was tested.
- Data Provenance: The tests were conducted following recommended procedures outlined in consensus standards (ISO 7176 series). The document does not specify the country of origin for the testing or whether the data was retrospective or prospective, but it's non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a non-clinical performance assessment of a mechanical device against international standards, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is a technical performance test, not a subjective assessment requiring adjudication.
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. This is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this medical device is adherence to established international performance standards (ISO 7176 series) for mechanical wheelchairs. These standards define the acceptable physical and functional characteristics.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device that requires a training set.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).