(44 days)
The Danyang Huayi® K7 Wheelchair is indicated for providing mobility to persons limited to a sitting position.
The Danyang Huayi K7 wheelchair is a wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid. mechanical, steel frame and nylon upholstery back and seat that meet ISO 7176-16: Resistance to ignition of Upholstered parts. It has two 24" rear wheels and two 8" front casters for turning and maneuverability. The Danyang Huavi K7 wheelchair is intended for the use in indoors and outdoors, over smooth surface (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that free of large obstacles and inclines greater than 9 degrees.
The Danyang Huayi K7 Wheelchair is a mechanical wheelchair, and its acceptance criteria and performance are primarily based on conformance to international standards, rather than a clinical study measuring diagnostic performance of an AI-powered device.
Here's a breakdown of the requested information based on the provided document, adapted for a medical device that is not an AI diagnostic tool:
Acceptance Criteria and Device Performance (Danyang Huayi K7 Wheelchair)
The acceptance criteria for the Danyang Huayi K7 Wheelchair are defined by its successful conformance to a series of ISO standards for wheelchairs. The "reported device performance" in this context is the statement of conformity to these standards.
| Acceptance Criteria (ISO Standard) | Reported Device Performance |
|---|---|
| ISO 7176-1: Determination of static stability | Conforms |
| ISO 7176-3: Determination of efficiency of brakes | Conforms |
| ISO 7176-5: Determination of overall dimension, mass, and turning space | Conforms |
| ISO 7176-7: Measurement of seating and wheel dimensions | Conforms |
| ISO 7176-8: Requirements and test methods for static, impact, and fatigue strengths | Conforms |
| ISO 7176-11: Test dummies | Conforms |
| ISO 7176-13: Determination of friction of test surface | Conforms |
| ISO 7176-15: Requirements for information disclosure, documentation, and labeling | Conforms |
| ISO 7176-16: Resistance to ignition of upholstered parts - requirements and test methods | Conforms |
Additional Information (Not Applicable for a Non-AI Mechanical Device):
The following sections are designed to evaluate AI-powered diagnostic devices. Since the Danyang Huayi K7 Wheelchair is a mechanical mobility device, these criteria are not applicable and are addressed as such below.
- Sample size used for the test set and the data provenance: Not applicable. This is a mechanical device, not an AI diagnostic tool using a test set of data. Testing would involve physical prototypes/production units.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a mechanical wheelchair is objective measurements and performance against engineering standards, not expert interpretation of data.
- Adjudication method (e.g., 2+1, 3+1, none) 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. This is not an AI diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device, no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device is based on the objective measurements and performance criteria defined by the specified ISO standards for wheelchairs.
- The sample size for the training set: Not applicable. This is a mechanical device, not an AI algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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).