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the intended use of the Invacare M71 Power Wheelchair is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.

The Invacare Model M71 power wheelchair is a battery powered, motor driven device with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. It is a rigid or "non- folding" type power wheelchair, with mid wheel drive capability.

The wheelchair frame is of rigid or non-folding type design. The wheelchair frame is of rigid or non-folding type design. The frame consists predominately of round 1 1/4 " diameter x .07 wall, steel tubing. The frame is of welded construction. The chair can be disassembled into 6 pieces without the use of tools for transport in vehicles that are not equipped with wheel chair lifts and ramps. To easy re-assembly, the mating parts are color-coded or labeled at the joints. Painted shrouds are used to conceal the wheelchair frame, motors and controller.

The wheelchair is designed with front wheel, walking beam type suspension. That is, the front swivel casters are mounted to two separate front extension frame members, and are thus, independent of each other. Each extension frame member pivots independently in a vertical plane about a horizontal axis. This allows the chair to better negotiate small obstacles such as curbs, or ramps, from a complete stop. The rear casters pivot as well, and also serve as wheelchair anti-tippers.

The Invacare M71 wheelchair incorporates a direct, drive, which includes two separate right angle gear motors. Because it is a direct drive system, there are no belts, pulleys, chains, sprockets or the like, to periodically adjust or maintain. Both gearboxes are sealed and maintenance free.

The Invacare M71 wheelchair is powered by two 12 volt, U-1 deep cycle gel cell batteries. The operating range; between battery re-charging is approximately 12 miles. Range will vary with battery condition, surface terrain and operator weight. The On Board Charger is standard.

The provided text is a 510(k) summary for the Invacare Model M71 Power Wheelchair. It focuses on demonstrating substantial equivalence to predicate devices and performing performance testing. It does not describe an AI/ML device or a study involving human readers or ground truth establishment in the typical sense of AI/ML evaluation.

Therefore, many of the requested categories are not applicable to this document. I will fill in the relevant information and indicate when a category is not applicable for this specific type of device submission.

Here's the breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for performance testing. It refers to "the Invacare M71 Power Wheelchair" which implies testing was done on the device (or representative units) itself, not a dataset of patient data.
• Data Provenance: Not applicable in the context of typical AI/ML data provenance (e.g., country of origin, retrospective/prospective). The testing relates to the physical device's performance against a standard.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable. Ground truth, in the context of AI/ML, refers to validated labels or outcomes for data. This document describes performance testing of a physical medical device against an engineering standard, not an AI/ML model evaluated against expert-derived ground truth.

4. Adjudication Method for the Test Set

• Not Applicable. As there's no expert-derived ground truth for an AI/ML output, there's no adjudication method described. Performance against the EMC standard would be assessed by engineers and test equipment.

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

• Not Applicable. This document pertains to a power wheelchair, not an AI/ML diagnostic or assistive device where human reader studies would be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This describes a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Not Applicable. The "ground truth" for the device's performance is adherence to the specified engineering standard (ISO EMC Draft Standard 7176-14) for electromagnetic compatibility. This is an objective measurement against defined criteria, not expert consensus, pathology, or outcomes data in the AI/ML sense.

8. The Sample Size for the Training Set

• Not Applicable. This device is a power wheelchair, not an AI/ML model; therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.

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