(11 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
The AVANTICARE Mechanical Wheelchair, MS-8000 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The dcvice can bc disassembled for transport and it is foldable easily. The device uses a standard sling type back and scat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
The provided document is a 510(k) premarket notification for a mechanical wheelchair (LERADO, AVANTICARE Mechanical Wheelchair, MS-8000). The document primarily focuses on establishing substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study information, based solely on the provided text:
Acceptance Criteria and Device Performance (LERADO, AVANTICARE Mechanical Wheelchair, MS-8000)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | To provide mobility to persons restricted to a sitting position. |
| Applicable Performance Standards | Meets applicable performance requirements as specified in ANSI/RESNA WC vol. I and ISO 7176 Wheelchair Standards. |
| Flame Retardancy | Upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant. |
| Weight Limit | 100 kgs (same as predicate device). |
| Foldability | Can be disassembled for transport and is easily foldable. Mainframe is foldable (same as predicate device). |
| Overall Dimensions | Similar to predicate device (with some differences noted, not impacting safety). |
| Upholstery Material | Back upholstery material is the same resistance-ignitability fabric as the predicate device. |
| Seat Heights | Small difference compared to predicate device, but not leading to any safety hazard. |
| Hanger and Rear Axle Designs | Same as predicate device. |
| Caster Sizes | Different from predicate device; predicate device's caster size is smaller and moves more easily. |
| Overall Appearance | Differences exist between the new device and predicate device, but these are noted as "not safety aspect." |
| Weight and Size | Larger than predicate device, intended to make the user feel more comfortable during transport. |
| Optional Accessories | Same as predicate device, offering users the same choice of needed accessories. |
Study Information:
-
Sample size used for the test set and the data provenance:
The document does not specify a separate "test set" in the context of an AI/algorithm-based device. The performance testing refers to meeting established industry standards (ANSI/RESNA WC vol. I and ISO 7176 Wheelchair Standards) rather than a study on a specific dataset of patient outcomes or expert interpretations. The device itself is a physical product (mechanical wheelchair). Therefore, data provenance is not applicable in the typical sense of medical imaging or diagnostic algorithms. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a mechanical device, not a diagnostic or prognostic algorithm that requires expert ground truth establishment for a test set. Acceptance criteria are based on engineering standards and design comparisons. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as there is no test set requiring expert adjudication for ground truth. -
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. The device is a mechanical wheelchair and does not involve AI assistance or human readers. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a mechanical device, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a mechanical wheelchair, the "ground truth" for performance is established by adherence to recognized engineering and safety standards (ANSI/RESNA WC vol. I and ISO 7176 Wheelchair Standards) and by direct comparison of physical and functional attributes to a legally marketed predicate device. The information provided about "Upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant" is also a type of regulatory-defined ground truth for a specific material property. -
The sample size for the training set:
Not applicable. This is a mechanical device, not an algorithm that requires a training set. -
How the ground truth for the training set was established:
Not applicable, as there is no 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).