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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."

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.

1. 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."
2. 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.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. 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.
6. 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).
7. The sample size for the training set: Not applicable. This is not a machine learning or AI device.
8. How the ground truth for the training set was established: Not applicable.

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