(212 days)
Convaid's Champ model CH10 is a lightweight non-ridge high strength aluminum and steel manual wheelchair with a tilt and recline mobility system for everyday indoor and outdoor use on flat firm terrain. The Convaid Champ is a self or attendant propelled device, its' intended function and use is to provide mobility to children with physical disabilities who are frequently or permanently nonambulatory and limited to a sitting position.
In addition the Champ CH10T transit model has been tested and approved for use as seating in a motor vehicle when used in conjunction with an approved fourpoint, strap-type tiedown system per ANSI-RESNA WC-19:2000.
The Champ CH10 and CH10T are lightweight folding aluminum and steel framed wheelchairs with a seating module that can be used with an optional activity base. It contains the same typical components found on most manual wheelchairs. Champ CH10T transit model is the CH10 model with the addition of transport anchors. The CH10T model has been crash tested to WC- Vol 1 section 19:2000 and approved for use as seating in a motor vehicle.
The Convaid Champ Manual Wheelchair (model CH10 and CH10T) is a lightweight folding aluminum and steel framed wheelchair designed to provide mobility for children with physical disabilities. The CH10T transit model includes transport anchors and has been crash-tested for use as seating in a motor vehicle.
Here’s a breakdown of the acceptance criteria and the study proving the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| RESNA WC 1:2009-1 | Met applicable requirements |
| RESNA WC 1:2009-3 | Met applicable requirements |
| RESNA WC 1:2009-5 | Met applicable requirements |
| RESNA WC 1:2009-7 | Met applicable requirements |
| RESNA WC 1:2009-8 | Met applicable requirements |
| RESNA WC 1:2009-15 | Met applicable requirements |
| RESNA WC 1:2009-16 | Met applicable requirements |
| ANSI-RESNA WC Vol 1 section 19:2000 (CH10T only) | Crash-tested and approved for use as seating in a motor vehicle |
| ISO 10993-5 (Biocompatibility - Cytotoxicity) | Met applicable requirements |
| ISO 10993-10 (Biocompatibility - Irritation and Sensitization) | Met applicable requirements |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of human studies or data. The testing described is primarily non-clinical, evaluating the physical device against established performance standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This section is not applicable as the study involves physical testing against established ISO and RESNA standards, not expert-adjudicated ground truth for a test set of data. The "ground truth" or acceptance criteria are defined by the performance requirements outlined in the standards themselves.
4. Adjudication Method for the Test Set
This is not applicable for non-clinical performance testing against established standards. The determination of whether the device "met applicable requirements" would be made by the testing facility based on objective measurements and compliance with the specified parameters of each standard.
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
This is not applicable. The device is a manual wheelchair, and the described studies are non-clinical performance tests against engineering and safety standards, not an AI-powered diagnostic tool requiring MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable for a manual wheelchair. The performance tests are performed on the physical device itself.
7. The Type of Ground Truth Used
The ground truth used in this context is the performance thresholds and specifications defined by internationally recognized standards for wheelchairs and medical devices. These include:
- RESNA WC standards (e.g., WC 1:2009-1, 1:2009-3, etc.) for various aspects of wheelchair performance, durability, and safety.
- ANSI-RESNA WC Vol 1 section 19:2000 for crash testing and occupant safety in motor vehicles.
- ISO 10993-5 and ISO 10993-10 for biocompatibility of materials.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for an AI algorithm. The performance evaluation relies on the device's ability to meet the predefined criteria of the mentioned industry standards.
§ 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).