(8 days)
To provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor or indoor.
It consists of a rigid, mechanical, steel frame and nylon upholstery back and seat. It has two 24" rear wheels and two 8" front casters for turning and maneuverability.
The provided text describes a 510(k) summary for the HAIDA HD 11 Manual Wheelchair. As a manual wheelchair, the device is subject to mechanical and safety performance testing rather than the kind of AI/algorithm performance studies often associated with diagnostic or image analysis devices. Therefore, many of the requested categories (like sample size for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance) are not applicable to this type of medical device submission.
Here's the breakdown based on the provided text:
Acceptance Criteria and Device Performance
The device's performance is demonstrated by its compliance with established industry standards for manual wheelchairs.
Applicable sections from the provided text:
"It meets the applicable performance requirements as specified in ANSI/RESNA WC Vol. 1 Sec. 1, Sec.5, Sec.7, Sec.8, Sec.15, Sec.16 and California Bureau of Home Furnishings 117."
| Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|
| ANSI/RESNA WC Vol. 1 Sec. 1 (Requirement for Wheelchairs) | Met |
| ANSI/RESNA WC Vol. 1 Sec. 5 (Dynamic, Static, and Impact) | Met |
| ANSI/RESNA WC Vol. 1 Sec. 7 (Fatigue) | Met |
| ANSI/RESNA WC Vol. 1 Sec. 8 (Strength) | Met |
| ANSI/RESNA WC Vol. 1 Sec. 15 (Flammability) | Met |
| ANSI/RESNA WC Vol. 1 Sec. 16 (Stability) | Met |
| California Bureau of Home Furnishings 117 | Met |
Non-Applicable Categories for this Device Type:
The following categories typically apply to AI/software-based medical devices or diagnostic tools. Since the HAIDA HD 11 Manual Wheelchair is a mechanical device, these concepts are not relevant to its 510(k) submission.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a mechanical device. Performance testing is typically conducted on representative product units, not "data sets."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical devices is defined by compliance with engineering standards, not expert consensus on diagnostic 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 device is not AI-driven or diagnostic.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a manual device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical devices, ground truth is defined by objective engineering specifications and adherence to recognized performance standards (e.g., ANSI/RESNA).
- The sample size for the training set: Not applicable. This is not a machine learning or AI device.
- 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).