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HAIDA HD21 powered wheelchair is intended for an indoor/outdoor power wheelchair that provides transportation for disabled or elderly persons limited to a seated position.

It is a motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

The HAIDA HD21 powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market.

The provided text is a 510(k) summary for a powered wheelchair (HAIDA HD21). It does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

The document primarily focuses on:

• Device Identification: Trade name, common name, classification, and product code.
• Predicate Devices: Identifying similar devices already on the market (CWD01 and KV10HB).
• Intended Use: Describing the purpose of the powered wheelchair.
• Device Description: Briefly outlining the design as similar to existing powered wheelchairs.
• Substantial Equivalence: Stating that the HAIDA HD21 is substantially equivalent to the predicate devices and that any minor differences do not raise new safety or effectiveness concerns.
• FDA 510(k) Clearance Letter: Formal approval from the FDA based on the substantial equivalence claim.
• Indications for Use Statement: Detailed description of how the device is intended to be used.

Since the provided text does not describe an active study or acceptance criteria, I cannot fill out the requested table and information. This kind of information is typically found in a "Performance Data" or "Clinical Data" section of a 510(k) submission, which is not present in the provided excerpts.

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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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